Oncology Clinical Research Coordinator III

## Description **Job Title: Clinical Research Coordinator III- Oncology** **FSLA Classification:** Non-Exempt **Reports to:** CRC Manager **Job Summary/ Objective:** The Clinical Research Coordinator III is responsible for supporting the management and oversight of clinical trials. This role involves working closely with a team to ensure the smooth execution of research studies under the guidance of the Investigator and CRC Manager. **Essential Functions:** ***Overseeing Clinical Trials:*** - Ensure smooth conduct of study visits and clinical trials. - Monitor study participants’ health throughout the trial. - Schedule study visits within protocol-required timelines - Coordinate lab work, imaging, and other required procedures - Document all aspects of the study visit and subject status. ***Data Collection and Analysis:*** - Collect and enter data obtained from study visits into source documents, study logs, and EMR, as well as EDC where data management personnel are not assigned. - Assist data management team with resolution of queries ***Participant Interaction:*** - Educate study participants about study objectives and visit procedures. - Communicate with study participants regarding any adverse events or side effects and the management of them. - Administer applicable questionnaires. - Monitor participants' adherence to protocol guidelines. ***Collaboration and Compliance:*** - Liaise with laboratories - Liaise with Imaging vendors - Liaise with pharmacy staff and infusion nurses - Liaise with regulatory and quality assurance departments on protocol adherence and documents. - Monitor study compliance with protocols and ethical standards. - Ensure adherence to regulatory requirements. ***Record Keeping:*** - Maintain research records, including source documents, study logs, case report forms, and EMR - Direct specimen collection, labeling, packaging, transport, shipping, and storage. ***Logistics and Supplies:*** - Ensure all necessary equipment and supplies are in stock and functional. **Education/Experience/Skills:** ***Education:*** Bachelor's degree preferred in a health-related field ***Experience***: +3 years of experience in Clinical Research **Skills:** ***Regulatory*** - Filing and accessing documents, Study Submission Assistant, Conduct Close-out Visits - Report protocol deviations and SAEs to the IRB (where not performed by the Research Navigator) ***Finance*** - Stipend payments - Manage site budgets - Insurance Coordination ***Subject Interaction*** - Recruit, interview, screen, enroll, and randomize subjects - Obtain Informed Consent - Collect medical history - Conduct study visits - Triage patients' questions ***Administrative*** - Source documentation - EDC completion - Query resolution - AE/SAE documentation and reporting - Address protocol violations and deviations - Order/ maintain supplies ***Clinical Skills*** - Phlebotomy preferred - Vital Signs - EKG - Order and organize lab reports - IP Administration - Manage Medical Records ***Others*** - Support training and answer questions of other staff members - Support monitoring visits - Leads sponsor communication - Manage subject visits during managers’ absence - Liaise with Investigators in manager’s absence **Working Conditions/ Physical Demands:** Standard operating hours are Monday through Friday, 8:00 a.m. to 5:00 p.m. May be required to complete job-related tasks outside of that time frame more than a standard 40-hour work week. Requires prolonged walking, standing, bending, stooping, and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires a normal range of hearing and eyesight to record, prepare, and communicate appropriate reports. **Travel required**: as needed (travel to IMs may be required) **Disclaimer** This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may…