Research Coordinator

Job Summary

The Clinical Research Coordinator (CRC) is a specialized research professional working with, and under the direction of the clinical Principal Investigator (PI) on multiple ongoing research studies. Utilizing Good Clinical Practice, the Clinical Research Coordinator ensures assigned studies are conducted in accordance with Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), local regulations; Institutional Review Board Approvals, and Memorial Healthcare policies and procedures.

Primary Job Responsibilities

• Ensures human subject protections via diligence in research participant screening, recruitment, consenting, enrollment, randomization, monitoring of treatment, and follow-up procedures, ongoing risk assessment related to research interventions and protocol activities.
• Ensures ongoing research informed consent, addresses participant questions throughout study participation, and supports their goal for participating or terminating study participation.
• Captures and submits data accurately and efficiently.
• Maintains participant privacy, confidentiality, and safety of patients enrolled in clinical trials.
• Communicates effectively with research participants and their families, the research team, principal investigators, external study sponsors, primary care providers (e.g., clinical nurses, physicians, etc.), ancillary staff and the IRB to ensure protocol adherence, participant safety and regulatory compliance.
• Participates in study site activation activities, including regulatory documentation, training of research team and impacted departments.
• Supports regulatory efforts in the maintenance of regulatory documents in accordance with Memorial Healthcare Standards of Practice and applicable regulations.
• Maintains accurate documentation of study stipend and reimbursements per study protocol informed consent and budget.
• Acts as a liaison between site, investigators, principal investigator, Memorial Healthcare, IRBs and study sponsors.
• Creates study related reports as requested.
• Participates in meetings and provides information regarding applicable clinical trials.
• Participates in continuing education activities related to research to improve knowledge for job performance.
• Ensures compliance with research protocols by providing ongoing quality control audits.
• Participates with the PI and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance.

JOB SPECIFICATIONS

• Education: Bachelor’s degree in a scientific, health related, or business administration program preferred. At a minimum, a candidate must have a Bachelor’s degree with recent experience in a clinical setting.
• Experience: Minimum 2 years prior clinical experience or equivalent clinical trial experience. 1-2 years experience with research related activities with clinical practice, ICH guidelines, FDA and OHRP regulations, IND, SAE reporting, and protection of human research participant standards, regulations and laws preferred.
• MS Word, Excel, Outlook, EMR experience: Required.
• BLS: Specialized Certificates/Licenses: Clinical Research Certification CCRC/CCRP preferred, but not required.