Clinical Research Associate / Research Administrator Flashcards
what important twin studies do you know about specific to psychology
newbauer study
separation of orphaned identical twins and triplets into homes with different economic climates
anything to do with genetic component and ‘risk’ of mental health illness
e.g Sz
9% for 1st degree relative, 27% for children with 2 affected parents and 50% for MZ twins
basic principle that in MZ twins reared in different environments, the % risk of concordance is indicative of the genetic heritability of disorder
- lack of consideration of shared / differences during prenatal environment
what important twin studies do you know about
by twinsuk
ultraprocessed foods
identical twins - same nutritional values food but one UP and one whole food
blood sugar and fat level increased, with headaches and not satiated
PREDICT
no one size fits all for dietary advice as even in MZ twins reaction to food groups and same diet is not the same
- variation in blood responses
- MZ only shared 37% of gut bacteria (strangers is 35%)
what is the general utility of using twins (i.e Mz vs Dz and the science behind it)
monozygotic = identical - 100% same dna genomes and always the same gender - developed from 1 embryo (fertilisation of one egg by one sperm)
- idea is if something is largely influenced by genetics, you would expect to see similar levels / prevalence in MZ twins (& at the same time reveals the extent of environmental influence)
dizygotic (fraternal) = non-identical - developed from 2 separate embryos (fertilisation of 2 eggs by 2 sperms)
genotype & phenotype
geno - combination of alleles possessed for a specific gene - purely from parents
pheno - combination of individuals observable characteritstics and traits - influenced by ^ & environmental, lifestyle and epigenetics (how env influence gene expression) factors
have to consider the equal environments assumption - assuming that extent to which MZ and DZ twins share the same environments is the same - this may not be the case
how will i demonstrate the px always comes first + create a safe and positive experience for them
How do you handle participant queries or concerns to ensure a positive experience?
Can you describe a time you had to manage a difficult or unresponsive participant? How did you handle the situation?
taking time to listen, read and understand the information provided by participants and their family members both over the phone, email, and in written information.
Should I either be told or get the sense that they are having a more negative experience, or do not feel completely safe, I would urgently flag this to the appropriate team member, as a priority, to demonstrate the patient always comes first.
prev demonstrated in research by flagging data decline to relevant team members and inclusive and safe experience for blind patient in exercise class
TwinsUK example: despite being ‘eligible’ considering the symptoms of a patient with mci and the comfortability and suitability in taking part in the MRI study, considering issues with informed consent, and liased with mri team + clinic team to ensure safe, comfortable visit, with twin having to leave the room at points - thanked me for my clear communication and coordination of the day
what is my understanding of the term ‘good clinical practice’
& what is the general purpose of healthcare research?
policy knowledge: GDPR, data proection act, mental capacity act
agreed international standard for conducting clinical research
GCP in research means you will (look for a sum-up of the training we undertake):
protect the rights and safety of patients taking part in research studies
collect reliable research data
(by the NIHR - national institute for health and care research)
purpose: - through evidence-based solutions
* improving health outcomes
* improving patient wellbeing
* impacting health policies
ethics approved by HRA (health research authority)
IRAS - international research application system
correct receival of informed consent - both at the time of signing up and prior to the study on the day & provision of a detailed PIS (strengths and weaknesses of taking part, where will data be stored, what samples will be taken, what results, how data will be used)
keeping an up to date delegation & protocol log of all staff members involved, signed, with research CV, training they need / have undertaken (e.g facility induction and redcap use), and their roles within the study
The rights, safety, and well-being of participants are the most important considerations and should prevail over the interests of science and society.
what are the administrative duties i have undertaken in chief-pd (currrent role)?
large scale data entry
large scale scanning and uploading of documents into correct folders, marking information onto the correct spreadsheets
collection of data from another site
sending out of studies materials
relaying patient queries to the correct staff member
what are the administrative duties i have undertaken in a primary care setting?
use of systmone and outcomes4health (learnt very quickly)
communication to patients, allied health professionals and third party bodies via email, referrals, telephones and post
reporting results, booking appointments, answering queries etc.
some patients were involved in studies so receipt of study documentation
What interests you about this position and why do you think you’d be a good fit?
first, cover why you want that position - why i’m interested (what about the role I want to learn e.g managerial, monitoring level, aligns with my strengths and career path
* interests: the possibility to use my current strong admin, recruitment, and study knowledge background, within this organisation, studies, and participant base, to elevate my current research career to contribute towards creating and amending core participant communications, problem-solve recruitment demands, facilitate multi-disciplinary team discussions, monitor study processes and progress, and having a strong role in reporting of study progess
* a few of my strengths include communication, both within and between various clinical teams (honed at GP) and with participants (over the phone and via email), strong organisation, time-management and prioritisation skills (completing masters alongside part-time 0-hours role, to ensure I got the best and my maximum contribution to both) and creative, knowledge based problem-solving, with a participant-centred approach
second, mention why specifically at twinsuk - thriving in this department, training, presenting, setting up scheduling meetings - want to progress my research career here
*
- have worked in my current role for just over a year, have put everything into it and have got a lot out of it, including the proactive training of a new staff members, development of unique communication templates, and recently intiating meetings and conversations across teams to aid recruitment, scheduling, and case-by-case problem solving, importantly knowing I would like to continue my career in research assistance and facilitation within this organisation, and using my unique knowledge base and recruitment stand point to positively contribute to this ASM role - discovered my ambition to continue and elevate my career in research
third: fast, timely handover to a knowledgable and fast learner who already understands the core of twins and mri study
- maternity cover requires a smooth handover, to someone willing and adept at learning fast, preferably with a foundational understanding of the role and the organisation (I fit this)
How have you tracked study and participant progress in previous roles? What tools or methods have you used?
leaving audit trails through various databases including redcap, systmone, and the admin and access dbs, excel spreadsheets
make a physical, timed note to ensure certain participants or queries are not missed and are dealt with within the appropriate times - keeping in mind the availability of relevant staff members + understanding who to contact in case of absence
collated and reported on current recruitment across a range of studies through keeping track of recruitment numbers, queries, and challenges, feeding back in a clear manner and asking appropriate questions to enable assistance/ set up conversations between different teams
what is involved in annual progress reports: what is currently being done e.g which meetings occur, how many twins have been seen, in line with targets, and how many we are hoping to see, who is in which role, any ethics updates
Can you describe a time when you identified a delay or issue in a study and how you addressed it?
Issue with automated emails, ensured that this issue was reported but at the same time ensured to send a manual email and keep a spreadsheet when reported in specific cases, to make sure recruitment not delayed
reducing the time taken to respond to participant queries and the number of participant contacts through creation of universal, but editable templates, keeping these updated, and recently encouraged other team members to include mention of other studies within the first recruitment email to ensure maximum study take-up
How do you ensure effective communication and collaboration with operational teams?
Have you ever worked with cross-functional teams? How did you handle any conflicts or miscommunications?
Describe a situation where there was a disagreement or conflicting priorities among team members. How did you facilitate a resolution
I am an active listener, which allows me to ask intuitive, to the point questions, for conversations to be as impactful and useful to all parties involved as possible
- I will keep in mind challenges to each team member & the knowledge they posses, to make sure the benefit of each collaborator is maximised e.g collating and summarising zygosity queries to the attention of my boss as well as the head of the lab team, expressing their urgency, being involved in the set-up of meetings, the development of a plan of action and importantly, the constant relaying and feedback to the participants urgently querying this, until a timely, faster solution was delivered and a standard set for future situations
my current role deals with cross-functional and multi-disciplinary teams daily, as twin queries often require communication with multiple team members across and external to the department
- miscommunications: keeping a precise and detailed audit trail to refer back to, taking ownership of anything unclear presented on my behalf, and feedback once a miscommunication has been resolved
- conflicts: personally and professionally I am strongly against conflict and handle stressful, testing situations calmly and rationally, making sure both parties are heard and understood - reflect to ensure this does not happen again, put procedures in place
- have witnessed and knowledge of workplace conflicts and having reflected on these, can often come about through personality clashes, or one/both members not feeling listened to / prioritising their teams needs - important to consider both sides, see from other POV and compromise by undertanding prioties and boundaries of the opposite party
Can you give an example of a process you implemented to improve study management?
study delivery: simply asking participants to tell us the best time to call, for control over our time rather than continuous phone disruptions
providing accurate, relevant feedback both proactively and when asked, on challenges, queries, and positives during recruitment, study queries and processes
describe the chief-pd trial? what have i learnt about clinical research whilst working there?
cholinersterase inhibitors to prevent falls in parkinsons disease
bristol med school - ageing and movement research group
- with PD, experienced a fall within previous year
largest trial using a novel drug treatment in the uk
600 participants from 39 uk sites
on cholinesterase inhibitors through transdermal patches (typically used for ppl with memory problems)
manage priorities under pressure
admin & booking for covid clinic alongside regular running of gp with reduced staff
what is twins uk?
health study of over 16 000 uk twins
multiple studies at one time
largest uk adults twin registry and most clinically detailed in the world
> 18 y/o
any questions?
PROSPECT study: particular interest of mine - haven’t worked on a diet specific study, particularly with a focus on motivations (dietary advice) and prevention, in a population beyond twins - working in the community presents a new challenge here
* Will there be an opportunity to be involved in this study as it begins to be rolled out and in what capacity
MRI study - as there is now ongoing data to be analysed, when might some preliminary findings/conclusions from different researchers begin to emerge using MRI data combined with twinsuk vast 30 year collection of health and historical linked data - can this be expected before the conclusion of the study in 3 years time? - will this influence the role / be something I will be involved with
facts to know about guys and st thomas’ research centre?
1 of 8 accredited health sciences research centres in the uk linked with king’s health partners
number 1 trust for clinical research in london
values the post holder requires?
put patients first
take pride in what they do
respect others
strive to be the best
act with integrity (honest and moral)
will you be able to acquire and communicate ‘excellent knowledge of current studies’
presentation and critique of screening tool in africa for cognitive deficits in those with HIV
high scoring and deep understanding of the research and the sphere it was in
what do you think your daily role would look like?
dynamic and fast-past, able to prioritise a diverse list of tasks throughout the day and across the week / month and willing to switch between jobs - keeping time-scheduled spreadsheets to stay on top of different prioritised workloads to avoid any backlogs and ensure timely completion
Maintaining clear and constant communication with admin and mri teams (e.g greeting and checking in at the start of each week), chairing and taking part in stakeholder meetings, including taking minutes, feeding back on study recruitment, engagement and challenges to operational meetings and in KPIs
weekly going over next batch uploads, % responses vs numbers invited, recruitment strategy with admin, checking charts for twins progress through the different stages of booking, collating recruitment information to contribute to weekly progress reports in kpis and annual reports
keep an eye on audits, and audit in any response to queries / challenges e.g twin arrival time, scan time - good way to monitor complaints
aware of twins feedback and any queries arising
Keeping on top of new staff training, study materials, their laptops, and running audits to ensure training up to date and data entry complete
what environmental influences can you think of?
gender (DZ)
culture
friend group
educational attainment
mental health
treatment by parents
teamwork
in research - dissertations, understood my strength was in data management and processing, took this job as I knew I could do it fastest
in healthcare - getting px her medication by end of day - ended in 2 positive reviews - good at delegating tasks and being realistic with my own timelines and able to ask for help
last minute recruitment - phoning and coordinating accom, travel as well as feeding back to team members before the deadline esp. for mris, good at coordinating when multiple contacts with the same twin, effectively relaying information to gauge help in the situation
Reflection / final statement - a good team player but also very comfortable with taking the lead, either when asked or proactively, using my strengths to benefit the team as well as understanding my limitations in terms of time, to effectively delegate
integrity
owning up to confidentiality error - early on in job and could have hidden behind superiors
ensured to contact the patient, take accountability, explain the situation and complaints protocol, gave the contact of the PM, px ended up being ok
workplace conflict
if unable to sort it myself, discuss sensitively with relevant team leaders and try to sort it at the level the situation occured rather than bringing more people in with escalation
why have you applied for this role and how do your qualities fit with this role?
good combination of my previous experience both at the academic and professional level (GP and research data entry / recruitment) but with exciting new pathways, more responsibility over study monitoring and offers to train and have more than an administrative impact on research
Background at Twinsuk of over a year got everything out of the current role and beyond, including training, active role in study schedules, recruitment plans, and expenses
Reinforced that this environment is ideal to support my learning and building confidence in new abilities e.g taking minutes and reporting on progress, and is an environment to be inquisitive and ambitious about my research career
biggest challenge coming into this role
scientific aspects of the research studies, coming from a predominantly psychological background
however, have a strong ability to read a scientific research paper, doing the neccessary reading to understand it & able to critique and analyse pros and cons - I was not confident about this coming into the role, especially communicating study information - I have built confidence in participant communications, study information and my ability to recruit
Shifting away from admin team, different priorities which may not always align with my previous colleagues - working within a new team, in communication with the admin team but prioritising the needs decisions made by the mri team and vicky - build on my already strong relationships between these teams, being a reliable and considerate ASM, understanding my priorities while ensuring the communicate undesirable results to teams clearly and with compassion
facilitating and holding meetings with multi-disciplinary team leads - take minutes in Ops, observe how department head clearly and orderly gets each team to report their updates , resolves problems and thinks critically, allowing other members to help, facilitating useful discussions - have contributed when I have felt relevant & presented a detailed recruitment summary when needed
very willing to learn, overthinker so overprepare as I want to be the best I can possibly be, and take constructive feedback to improve
different phases of a trial?
phase I - testing phase on a small population
phase II - re-testing on a larger population
phase III - larger population still and comparison to the current market
Tell us about a time you had to manage multiple studies or projects simultaneously. How did you prioritize your tasks?
part of my daily role to coordinate and facilitate the recruitment of twins into their eligible studies, having scheduling at the forefront
chief pd and masters degree, particularly during my dissertation - wfh vs office vs uni - take time to map out my week at the weekend to have a clear idea and setting time apart for unexpected daily tasks (time blocking for important tasks, less priority later on in the day/week) - use colour coding on spreadsheets as well as a daily/weekly to-do list
round up sentence: organised in personal, academic and professional life using to-do lists, daily reflections, and colour coded excel spreadsheets, as well as time blocking and prioritising to stay on top of my workload and anticipate and create time for unexpected work
- very happy and proactively look for courses to help with prioritisation/organisation/how to handle your workload independently
If a study needed an urgent amendment, how would you go about implementing it while ensuring minimal disruption?
having observed the management of multiple studies, as well as taking the operational notes each week for all twinsuk studies, I would ensure to prioritise meeting the relevant team members/collaborators to discuss the urgent amendment, have this written up precisely and accuracy, to avoid repetition, and feed this across to the relevant teams to action
important to have specific examples of why the amendment needed to be made, how it helps / what would happen if it wasn;t put in place
How would you handle a situation where participant engagement in a study is lower than expected?
have experienced this heavily within my current role, and have been involved at the administrative and operational level to problem-solve and discuss different options to engage participants
at the personal level, it has involved amending my communications to certain participant groups e.g young males more receptive over the phone, at the end of a work day, and mentioning first that they are due a visit, before presenting the study names/dates, and offering to provide most information over email, along with a plan of how they should go from here
- in general, research centres on males but twinsuk has opposite issue with most engagement from committed women >60 - definitely warranted to spend some time, using the VAP, and asking twins when communicating our research about what influences their engagement
- example of males doing mri - keen interest in results from clinic visit so focus on this with mri as an add on
thinking about more receptive participants e.g more visits, more recent, social media interest and emailing about other queries - using every opportunity to invite twins in and engage them with our research
important qualities for this role
organisation - dynamic role with many different aspects which may need prioritising throughout the day - time scheduled spreadsheets, daily and weekly to-do lists with time blocked for unexpected and important tasks - showed this doing dissertation x data entry role as working on this independently
attention to detail - data inspection and long periods of concentration required - have experience data cleaning, mass marking of foreign exam papers, remembering twin queries and individual situations, making detailed notes, to ensure I am on top of the situation and underpins my participant-centred approach
work independently and have a strong understanding of the research to relay onto patients and relatives
Strong monitoring of study to report on progress, targets, recruitment initiatives, and thinking proactively before problems arise e.g a protocol put in place when twin disagrees about eligibility, timely delivery of IFs
managing expectations and constant communications between teams - part of my current role, have an understanding of each team and members
“How do you ensure effective communication between various teams to keep everyone aligned on study progress?”
this ties into chairing meetings & reporting back on study targets and progress reports to external teams
ensure from my end that a my communication is clear, timely, and delivered apropriately to that team e.g recruitment and administrative perspective to admin vs filling slots and deadlines with mri team
think of an example of doing this at twins
“Can you explain your understanding of ICH/GCP guidelines and how they apply to the management of research studies?”
Can you describe a research project you managed and the key challenges you faced?
How do you track project deliverables and ensure they align with study timelines
colour time coded excel spreadsheet - weekly diaries with time blocking for essential, high priority activities
How do you handle sensitive information when interacting with study participants
more organisation / time management questions:
Tell me about a time when you had to juggle multiple competing deadlines. How did you manage them?”
“What systems or tools do you use to stay organized and ensure all study milestones are met?”
“How do you ensure that study-related documents and communications remain well-structured and accessible?”
Multiple deadlines: dissertation, online final exams, and data entry - transparent with each team about my other commitments and clear about my time-allocation and progress expectations - spent time reflecting and re-adjusting if certain tasks were not being met or rushed - if difficult making deadline / needing to re-allocate times then being transparent and delegating if need to
At TwinsUk: constantly have study targets, meeting at the end of the quarter as well as within the quarter for sub-studies - make an effort to document interested twins to book in a timely manner, and target those eligible for multiple studies to help hit targets - stay organised and meet targets through awareness, monitoring and communication between teams for maximum recruitment
Progress tracking spreadsheets, personally to-do lists and coloured time management spreadsheets for myself as well as study related targets
Have many communication templates, both incorporating study VIS’s and links, as well as my own communications including key detailed and FAQs - have passed this across to a newer colleague to aid written responses to a high level
How do you balance working independently with collaborating effectively with a research team?
Chief-pd: had an independent role of data entry, timely postage of study material but communicated daily about participant queries and needs with the larger team
Can you walk me through a problem-solving approach you took to resolve a critical study-related challenge
Alzheimer’s patient
Have you ever worked on a remotely conducted research study? What challenges did you encounter, and how did you overcome them?
How do you maintain clear and consistent communication in remotely delivered studies
Both my undergraduate and postgraduate dissertations recruited over 150 participants through social media outlets and word of mouth all remotely - responsible for the set up including ethics, survey creation, data collection and analysis and final write up
Knowledge of remote study on a large scale through operational meeting and minutes taking for the department - understand the importance of participant communication, especially due to elderly population, questioning study drop-out, missing test results, and not wanting to be involved, to help recruitment later down the line, as well as adaptation of study materials and communications for the elder, more frail target population - have witnessed the importance of target adjustment due to external influences (post), communications with involved teams (lab) and accessibility to participants + communicating study purpose & materials to admin in case they received communications
Situational questions:
‘Handle conflicting interests between 2 teams’
‘Deal with an urgent finding’
Conflicting interest: have knowledge of the conflicting interests that can occur between the mri (study) team vs the admin team at Twins - examples include machine servicing losing possible slots to meet participant recruitment numbers + disagreements on participant eligibility
Action: get a clear picture of both sides viewpoints, understand priorities lie with what is best for the study and the people carrying it out, relay this message clearly, explaining the reasons and consequences
Result: demonstrated seeing both parties viewpoints by listening and noting their thoughts, will take both standpoints into consideration in future
Urgent finding:
I have knowledge of and witnessed an urgent finding coming in, from an admin perspective
A few specific examples including urgent blood test results (picked up call and forwarded message to lab) and urgent incidental findings from MrI study
My previous action to take detailed notes before alerting the relevant team members involved in the reporting and contacting - going beyond this as an ASM, ensure it has been properly noted on the database, ensure the correct people who need to write a report are alerted and if not immediately available, alert another member, have a timeline of when each task should be completed by, checking each stage as a priority, to ensure participant is contacted asap but with a considered report and actions for them to take
Ensured I have followed protocol and have overseen the urgent finding from start to end, focused on the timely manner, and made it personal responsibility for each stage to be completed, making detailed notes and auditing along the way
What is a site file and what does this contain
Brief description of MRI study
Investigating early biomarkers of disease and ageing both in the body and the brain
Magnetic Resonance Imaging (MRI) is a non-invasive scanning technique that uses magnetic fields and radio waves to generate detailed images of the internal structures of the body. MRI allows us to safely see changes inside the body, often long before any clinical signs or symptoms are noticed.
Aiming for 2500 individuals over the 5 years
What is your understanding of the TwinsUk Biobank and current Programme of Research
PoR: holds all substudies under our umbrella programme of research, consenting to this biobank consents the twins to all studies they take part in, meaning individual consent forms and sub-studies do not need their own ethics applications, just within the biobank
Tell me about yourself
Why stay at TwinsUk and what I would like my career to look like in 5 years
TwinsUK has already developed so much in my first year, including rolling out 3 new studies: biopsy, eeg and chr x, as well as mri getting strongly underway, including spreading the word personally and having my twin friends join - from vital covid collaborations to the new community possibility for PROSPECT and hot in here (care homes) this is an exciting research hub where I can see my research career developing, improving my research management skills and learning from incredibly experienced and impressive lead researchers and management staff across the department
Real interest in working in research was sparked by undertaking 2 large online dissertations at university, followed by data management and processing role at the largest novel drug therapy trial in the UK (CHIEF-PD)
- this role aligns strongly with my career hopes, as I wish to be a study manager on a project, having all the information and responsibility on me - this is a great, well-timed step up from my recruitment and administration role which I have put a lot into, and advanced by training a colleague, getting involved in the expenses, taking departmental minutes, and feel I am ready for a new challenge in the environment I am currently thriving in
I have discovered and developed my strengths in communication, organisation, problem solving, and working with multiple teams, and want to advance these further, as well as develop newer skills such as tracking progress through data and chairing meetings, with this role
What do I know about the governance, set up, and maintenance process of trials
Look this up!
Understanding of study set up - what are the stages
My understanding driven by my 2 academic large-scale remote dissertations - understanding research area and gaps, ethics approval, why important? Participants targeted and recruitment plan for this, eligibility criteria and planning data to be collected, to what standard, and how this will be stored
difference between radiographer and radiologist
radiographer: undertake the MRI scans and obtain the images
radiologist: interprets MRI scan images and feeds back to participants about their results
how have I used research databases and software before, and how can I ensure reliability and consistency in progress reports?
large scale db in previous role to data clean, monitor, enter and report on missing data or trends of inconsistencies - checked for errors of others - fast-paced with high attention to detail
in this role: crf manager, access and admin db, redcap - training of a colleague and accessing data for other teams who are unable to get this data themselves
experience creating progress reports: presenting updates on data, results and graphs to academic supervisor - ensured my reporting was uniform and comparable each time, making direct comparisons to previous reports and being transparent about any reductions
- ensured reporting in Ops was in line with usual reporting of recruitment, sought out information needed from colleagues, collated all current number and descriptive data, as well as predicting future progress using recruitment methods - and anticipating any changes
reliability: reporting the same, similar graphs not changing this weekly - helpful to have this peer checked
accuracy: using software where possible to collate the numbers, cross-checking these, constant monitoring for missing data, alerting and training the relevant teams if necessary
