Senior Clinical Research Coordinator

American Oncology Partners, PA; United States; On-site; USD 61,000 - 88,000; Full time

Benefits offered by this job

Health insurance

401(k) match

Paid time off (PTO)

Tuition assistance

Job summary

Oncology Consultants in the United States seeks a Senior Clinical Research Coordinator to oversee clinical trials from initiation to close-out. You will support investigators, ensure regulatory compliance, and mentor staff in data capture, safety reporting, and study documentation.

The role requires coordinating patient recruitment, conducting visits, and maintaining study records across multiple trials while communicating with sponsors, IRBs, and physicians.

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.

Responsibilities

• 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.
• Patient Recruitment, Enrollment & Study Coordination: Coordinate patient recruitment, enrollment, scheduling, and overall subject participation throughout the clinical trial.
• 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.
• Data Management, Documentation & Monitoring Support: Maintain accurate study documentation, case report forms, and support sponsor monitoring and audit activities.
• Research Program Support, Communication & Project Coordination: Support research department operations, communication, reporting, and overall research program coordination.

Skills

Clinical research coordination

Regulatory compliance

Patient recruitment

Data management

Communication

Education

Life sciences degree

RN (Registered Nurse)

Bachelor of Science

PhD

MD

Job description

Location: Oncology Consultants - Medical Center CCO Office

Hiring Range: $61,400.00 - $88,175.00

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% American Oncology Network AON is an alliance of physicians and veteran healthcare leaders dedicated to ensuring the long-term success and viability of oncology diagnosis and treatment in community-based settings. It is the fastest growing national network of community oncology practices delivering local access to exceptional cancer care. AON serves its expanding network of partner practices by providing proven practice management expertise. Our employees across the country work together to empower physicians to make cancer care better. By driving integrated, collaborative care, we are proudly helping community oncologists deliver the highest quality care to every patient. Cancer touches everyone. Being able to make a difference in the lives of those fighting this disease is something our employees at AON cherish and never take for granted. A career in oncology offers all sorts of rewards. But working at AON offers employees more than most. As a fast-growing national company, the opportunity to join a national workforce with flexible work options is available. We offer competitive compensation packages that include comprehensive health insurance with a robust provider network. Our 401k, which offers a 100% match and investment options, is available to full-time and part-time staff members, and we feature a generous Paid Time Off (PTO) program. At AON, we offer you more than a job, we offer you a career. As a network of independent oncology practices working together as one, we host annual summits each year, providing our employees a chance to collaborate with AON peers from across the country. Promoting from within is a priority at AON, and we support our team members continued growth through professional development programs and tuition assistance.