Position Summary

The Senior Clinical Research Coordinator is responsible for the coordination of the clinical trial process from site study initiation through study close out. The SRCRC supports the efforts of the Principal Investigator and Sub-investigators in screening, enrollment, the informed consent process and the treatment of patients on clinical trials and is responsible for data collection, documentation and record-keeping activities pertaining to multiple clinical research studies according to Oncology Consultant’s SOPs, GCP and FDA/ICH guidelines. The SRCRC is responsible to train and mentor research staff. The Senior Clinical Research Coordinator functions under direct supervision of the Research Department Manager. This role will require that the SRCRC support and/or lead projects or programs within the Research Department. This position will require the ability to communicate effectively with physicians, coworkers, research sponsors, collaborators, and patients.

Key Performance Areas

KPA 1 – Study Start-Up & Regulatory Compliance

Responsible for study feasibility, regulatory submissions, and study initiation activities to ensure all clinical trials meet regulatory, IRB, and protocol requirements.

• Apply knowledge of study design to evaluate protocol feasibility at the site.

• Assist in preparing and submitting documents to Institutional Review Board (IRB).

• Participate in study site initiation activities.

• Attend investigator meetings and clinical trial conferences as directed.

• Submit protocol amendments and progress reports to IRB.

• Prepare for and participate in FDA inspections.

• Ensure informed consent is properly obtained and documented prior to study procedures.

• Document protocol deviations and exemptions.

• Maintain secure storage and appropriate disposal of study-related documents.

• Protect patient confidentiality and privacy.

• Assist in maintenance of budgetary data for each clinical trial.

KPA 2 – Patient Recruitment, Enrollment & Study Coordination

Coordinate patient recruitment, enrollment, scheduling, and overall subject participation throughout the clinical trial.

• Participate in subject recruitment and evaluation of eligibility.

• Review inclusion/exclusion criteria with investigator to confirm eligibility.

• Conduct subject interviews to assess willingness and ability to complete study.

• Maintain patient screening and enrollment logs.

• Review protocol requirements, informed consent, and follow-up procedures with subjects.

• Schedule research-related patient visits and follow-up visits.

• Follow randomization procedures per protocol.

• Assess subject compliance with test drug and study procedures.

• Provide subjects with information on reporting study-related events.

• Contact subjects for follow-up visits and new study information.

• Document telephone communications and patient interactions.

• Contact primary care providers regarding study participation as directed.

KPA 3 – Clinical Trial Execution & Patient Care Activities

Provide direct patient care and coordinate all clinical and protocol-related procedures to ensure study compliance and patient safety.

• Attend clinic visits with investigator and assist with study procedures.

• Perform peripheral venipuncture and phlebotomy (if licensed).

• Ensure proper specimen collection, processing, batching, and shipping per protocol.

• Prepare and ship study specimens per protocol manual.

• Obtain results and report to investigator.

• Ensure study drugs are dispensed per protocol and maintain accountability records.

• Review returned drugs for compliance and document findings.

• Review subject diaries and questionnaires.

• Recognize and report abnormal laboratory values.

• Collect and document adverse events for investigator review.

• Ensure overall subject compliance throughout the research study.

KPA 4 – Data Management, Documentation & Monitoring Support

Maintain accurate study documentation, case report forms, and support sponsor monitoring and audit activities.

• Obtain and review source documents and abstract data to study forms.

• Record accurate and timely data on case report forms.

• Maintain source documentation for all case report entries.

• Transmit data to sponsors or CROs as required.

• Resolve data queries.

• Schedule sponsor monitoring visits.

• Prepare case report forms and source documents for monitoring and audits.

• Meet with research team during monitoring visits to discuss queries and protocol issues.

• Participate in monitoring visits and audits.

KPA 5 – Research Program Support, Communication & Project Coordination

Support research department operations, communication, reporting, and overall research program coordination.

• Communicate effectively with subjects, investigators, sponsors, IRBs, and research team.

• Meet regularly with investigator and research team to discuss protocol progress.

• Assist in planning and implementation of research projects.

• Support outreach and patient recruitment efforts for clinical trials.

• Facilitate study tools for nurses, pharmacists, coordinators, and data managers.

• Attend practice management and research department meetings.

• Create and maintain clinical research databases tracking patient accrual and research activity.

• Maintain protocol synopsis for active projects.

• Assist in planning department coverage for clinic visits, data management, and meetings.

• Participate in educational and training activities and continuing education.

• Demonstrate commitment to superior customer service and professional communication.

• Responsible for organization and management of assigned research projects or programs.

Position Qualifications

Education

• Degree in the life sciences or health sciences such as Registered Nurse (R.N.), bachelor's in science, Doctor in Philosophy (Ph.D.), Medical Doctorate (M.D.), other.

Minimum Relevant Experience

• 5 plus years of clinical research experience.

Certifications/Licenses

• Continuing education participation is expected, and research certification through a recognized national organization (SOCRA, ACRP) is encouraged.

• NIH protection of Human subjects online course will be required every 2 years.

• IATA training will be required every 2 years.

Travel: 0 - 25%