Senior Clinical Research Coordinator
About The Position
The Senior Clinical Research Coordinator coordinates clinical trials from site study initiation through study closeout. The role supports Principal Investigators and Sub-investigators with patient screening, enrollment, informed consent, and trial treatment, and is responsible for data collection, documentation, and record keeping across multiple studies in accordance with Oncology Consultants’ SOPs, Good Clinical Practice (GCP), and FDA/ICH guidelines. The coordinator also trains and mentors research staff and may support or lead Research Department projects or programs. The position works under the direct supervision of the Research Department Manager and requires effective communication with physicians, coworkers, sponsors, collaborators, and patients. The position covers study feasibility and start-up, regulatory submissions and compliance, patient recruitment and enrollment, clinical trial procedures and patient care, data management, sponsor monitoring and audits, and research program coordination. It includes maintaining study records and databases, supporting investigators and research teams, and ensuring protocol compliance and patient safety. Travel is listed at 0–25%.
Requirements
- At least 5 years of clinical research experience.
- A degree in life sciences or health sciences, such as Registered Nurse (R.N.), Bachelor of Science, Doctor of Philosophy (Ph.D.), Medical Doctorate (M.D.), or another relevant degree.
- NIH Protection of Human Subjects online course, required every 2 years.
- IATA training, required every 2 years.
- Ability to communicate effectively with physicians, coworkers, sponsors, collaborators, and patients.
Nice To Haves
- Research certification through a recognized national organization such as SOCRA or ACRP is encouraged.
- Continuing education participation is expected.
Responsibilities
- Evaluate study feasibility and support regulatory submissions, study initiation, and compliance with regulatory, IRB, and protocol requirements.
- Assist with preparation and submission of documents to the Institutional Review Board (IRB), protocol amendments, and progress reports.
- Participate in site initiation activities, investigator meetings, and clinical trial conferences as directed.
- Prepare for and participate in FDA inspections, sponsor monitoring visits, and audits.
- Ensure informed consent is properly obtained and documented before study procedures; document protocol deviations and exemptions; maintain secure storage and appropriate disposal of study documents; and protect patient confidentiality.
- Assist in maintaining budgetary data for each clinical trial.
- Participate in subject recruitment and eligibility evaluation; review eligibility criteria with investigators; interview subjects; and maintain screening and enrollment logs.
- Explain protocol requirements, informed consent, and follow-up procedures to subjects; schedule study visits; follow randomization procedures; and assess subject compliance.
- Provide subjects with information about reporting study-related events, contact subjects for follow-up and new study information, document communications and interactions, and contact primary care providers as directed.
- Attend clinic visits with investigators and assist with study procedures; perform peripheral venipuncture and phlebotomy if licensed.
- Collect, process, batch, and ship specimens according to protocol; obtain results and report them to the investigator.
- Ensure study drugs are dispensed according to protocol, maintain accountability records, and review returned drugs for compliance.
- Review subject diaries and questionnaires, recognize and report abnormal laboratory values, collect adverse-event information for investigator review, and monitor overall subject compliance.
- Obtain and review source documents, abstract data to study forms, enter timely and accurate case report form data, and maintain source documentation.
- Transmit data to sponsors or CROs, resolve data queries, schedule monitoring visits, and prepare case report forms and source documents for monitoring and audits.
- Meet with the research team during monitoring visits to discuss queries and protocol issues.
- Communicate with subjects, investigators, sponsors, IRBs, and the research team; meet regularly with investigators and the research team to discuss protocol progress.
- Assist with planning and implementing research projects and support outreach and patient recruitment efforts.
- Facilitate study tools for nurses, pharmacists, coordinators, and data managers; attend practice management and Research Department meetings; and maintain protocol synopses and clinical research databases.
- Assist with planning department coverage for clinic visits, data management, and meetings; participate in education, training, and continuing education activities.
- Demonstrate superior customer service and professional communication; organize and manage assigned research projects or programs.
- Train and mentor research staff.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
