Roles and Responsibilities of a CRC/CTA (13) Flashcards
What is a Clinical Trial?
Any investigation in human subjects intended to discover or verify the clinical, pharmacological/ and or other pharmacodynamic effects of an investigational product(s), and/ or study absorption, distribution, metabolism and excretion of an investigational product (s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.
What is ADME?
Absorption
Distribution
Metabolism
Excretion
What is human research? What does it involve?
Is research involving human participants, who may participate through:
-taking part in survey, interviews or focus groups
- undergoing psychological, medical testing or treatment (clinical trial)
- being observed by researchers (observational study-psychiatry trial)
- researchers having access to their personal documents or other materials (medical records-database review)
- The collection and use of their body organs, tissues or fluids (e.g skin, blood, urine, saliva, bones, hair, other biopsy specimen) (genetics study)
- Their information (in individually identifiable, re-identifiable or non-identifiable form) being assessed as part of an existing published or unpublished source or database.
Define Clinical Research Coordinator
A specialized research professional working with, and under the direction of, the Clinical Investigator
-Handles the bulk of daily clinical trial activities
Where do Clinical Research Coordinator’s work?
Work in the hospital
Who leads the study of the Clinical Trial?
Clinical Investigator
Legally responsible for the management of a clinical trial at a site
PI (principle investigator)
-Lead the study
What does a CRC do? IAD
Identify- identification of side effects of the IP (investigational product)
Assess- check on the patients well being/ safety
Discuss- discussing the informed consent, drug usage, trial participation, patient counselling
What are the background of CRCs?
Medical professionals
-Nurses, physician assistants
Non-medical professionals
- science background
- experience based training
Training of CRC:
On the job training by experienced CRCs
-may be done by sponsored companies (CRA trains CRC)
Investigator meetings
PI and CRC attend, global meeting (how to conduct the study and all about the study)
Informal Interaction
(networking)
Formal training courses
- Professional organizations
- Universities
- NYP poly
What are the skills and personalities needed to be a CRC?
Mixture of duties:
- Administrative- paper work
- Business- project management
- Medical - patient assessment
- Patient oriented-patient education, counselling, patient well being
Skills:
- have extremely good organizational skills
- Be detail-oriented
- Be people oriented
- Be self confident, flexible and adaptable to change
- Be focused, manage time well and follow through on problems and commitments (challenging, fast paced)
What are the roles and responsibilities of a CRC?
Play a key role in Clinical Research- they support, guide and motivate research participants while ensuring that the studies are carried out accurately, and with scientific and ethical integrity
Regardless of the particular research settings, the successful functioning of clinical research team revolves around the CRC
Overview of CRC’s responsibilities:
- Assist in evaluating new protocol for feasibility at the site
- Prepares the site for conducting the study
- Participates in Informed Consent Process
4.
CRC responsibilities:
What does assisting in evaluating new protocol for feasibility at the site involve?
- Review the protocol and other materials, such as the Investigator Brochure and informed consent form
- Review subject eligibility requirements
- Assess the ability to meet study timelines in light of other site commitments and overall feasibility
- Assess the resources necessary to do the study, including people, physical space, material
What does the investigator brochure include?
aka product leaflet
Includes anything about the drug
Pre clinical results/ Adverse event
Toxicity
IP= non-marketed drug
CRC responsibilities:
What does preparing the site for conducting the study involve?
Train the people involved
Set up and organize study files
Create or review study specific source documents and materials
Disseminate (spread/share/update) trial information to the rest of the study team
Create advertising, if appropriate
Prepare documents for submission to ethics committee
Collect the documents needed to initiate the study
Attend investigator meeting, as appropriate
Middle-man between doctor, patient and sponsor
CRC responsibilities:
What does participating in informed consent process involve?
Assist in writing consents
Present and discuss the informed consent form to potential subjects and answer their questions
Ensure that all necessary signatures and dates are obtained correctly in the informed consent forms
Document, distribute and file signed informed consent forms appropriately
Ensure that all amended consent forms are appropriately implemented and signed
CRC responsibilities:
What does managing study conduct throughout the trial involve?
Contact and screen potential subjects
Recruit subjects
Schedule subject and sponsor visits
Prepare for each subject visit to ensure that all appropriate study procedures are done
Assist the investigator with study subject visits
Ensure that all necessary data is gathered and recorded in the appropriate documents and case report forms
Review data collection forms entries for completeness, correctness and logical sense.
Review the source documents (medical records) and forms of adverse effects (side effects) that may be missed
CRC responsibilities:
What does managing study conduct throughout the trial involve?
part 2
Work with sponsor monitors (CRAs) during monitoring visits
Make corrections to case report forms, if appropriate
Resolve data queries
Ensure that study documents are complete, current and filed correctly
Ensure that study drugs accountability is done correctly for each subject and overall
Manage laboratory procedures (drawing blood samples, processing, packaging and shipping)
Record study supplies (lab kit, drug supply, study equipment) as necessary
Manage payment to study subjects, if appropriate
Assist studies closeout activities at the end of the study
Other duties the CRC is in charge of:
Maintain regular communications with sponsors and/or CROs, regulatory bodies, and the institution
CRO=contract research organisation
Collaborate with other department (laboratory, pharmacy, etc) as necessary
Assist the investigator with financial aspects of the trial, including budgeting and contracts
Solves problems
Coordinate sponsor and/or regulatory audits
Professionally represent the site to all people/ organizations in the best possible light
What are the career options for CRC?
In house clinical trial division in pharmaceutical companies
Clinical research organizations
Clinical trial units in hospitals
Clinical trial coordinators in specific departments/services
Regulatory authorities
What is the role of a Clinical Trials Assistant?
Work with the pharmaceutical companies/CROs
Administrative position
Support the clinical team in managing clinical trials project
(no patient interaction)
What are the typical roles and responsibilities of a Clinical Trial Assistant?
Assist the clinical trial team with accurate updating and maintaining clinical systems that track study site compliance and performance according to project timelines
Assist the clinical trial team in the preparation, handling, distribution, filing and archiving of clinical documents and reports according to SOPs
Assist the clinical trial team leader (CRAs) with preparation and distribution of study related supplies to various study sites
Assist with the tracking and management of CRFs (Case report forms)
Assist with tracking data queries and data management flow
What are the opportunities working in the clinical trial field?
High starting pay Flexible working schedule Better benefits -regional exposure as you travel for training and meetings -team building seminars -other skills training
Specialize and expertise
