job description examples Flashcards
l. Work with budgeting, billing, regulatory, and finance during study start-up and protocol amendments as needed
I work with our regulatory coordinator on a weekly basis, and have interacted with the billing office when assisting PM with invoicing questions, and handling patient reimbursement
oversee accurate and timely updates to CTMS
responsible for accuracy and timeliness of my own studies in CTMS; usually sit with new CRCs the first few times they are enrolling or editing a patient in CTMS to ensure accuracy and completeness
review metrics and enrollment, communicate challenges
ongoing efforts to review enrollment with our individual physician teams weekly, and as a larger collaborative discussion at staff and physician meetings
collaborate with departments and schedule SIVs during start up
I have scheduled and participated in numerous SIVs over the years, and am familiar with collaborations during start up with depts like CHPS, IDS, stem cell lab, apheresis, and radiology
development and maintenance of eCRFs and source doc tools
I have had the opportunity to develop and edit source doc tools such as eligibility checklists and CHPS worksheets; I have not edited or created eCRFs in CTMS but this is a skill I wish to learn
recruitment efforts
i. helping to facilitate regular pre-screening of patients. Creating patient brochures for our biobank study to be handed to patients or placed in clinic.
e. Closely monitoring study statuses, data issues and deadlines, drafting reportable event forms, sponsor and CRO interactions, troubleshooting:
i. being on such a supportive, interactive team like lymphoma, I am used to looping in others as needed including the PMs, APPs, RNs, PI, etc.; used to regularly checking in during weekly team meetings, staff meetings, on Teams group chats, etc. I think this level of communication and interaction is imperative to having successful, safe studies and a successful, supportive team
d. Ensuring a balanced workload, study feasibility and selection, staff priorities; stepping in when staff’s workload exceeds capacity, troubleshooting operational issues
i. providing input on study assignments for new CRCs and shifting study assignments around based on our team’s current needs and bandwidth
ii. stepping in when we’ve had staff turnover, learning new studies quickly, being delegated as a back-up for trials needing additional CRC or data help, or for trials assigned to brand new coordinators. Stepping in recently to process and ship for my team’s samples when biospecimen was unable to.
interviewing and hiring
i. is something I am grateful to have been looped into over the last 3 or so years, participating in in-person and remote interviews either by myself or with a CRN depending on which position we’re interviewing for; debriefing with PMs after interviews and through hiring decisions for CRCs and DM, holding 2nd interviews alone with potential finalist CRC candidates to chat with them one-on-one and discuss my role, have an open conversation about the day-to-day expectations, what I love about my role, etc.
ii. discussing the need for a full-time DM for our data-heavy, complex studies with the PMs. Deciding what this new workflow would look like for our team, and what their priorities would be
scheduling regular meetings and providing updates
i. have had the opportunity to do this by participating in staff meetings by leading the team through a new work instruction document or process (such as the CRU’s remote monitoring and pennbox instructions), and meeting regularly with onboarding CRCs and DM