Job Description

Research Coordinator Job Description

Position: Research Coordinator

Responsibilities:

Protocol Compliance:

• Identify primary and secondary study objectives and outcome measures.
• Adhere to federal, state, and institutional regulations, policies, and procedures related to clinical research.
• Comply with the company's SOPs.
• Communicate effectively with the interdisciplinary team to ensure protocol compliance and timely execution of protocol-related procedures.
• Collaborate with the Principal Investigator (PI), pharmacy, and other relevant personnel to ensure proper use of and accountability for study drugs.
• Provide protocol-specific education to clinical staff.
• Facilitate and participate in meetings/teleconferences with sponsors, monitors, and auditors.
• Report serious adverse events, unanticipated problems, deviations, violations, and noncompliance to the Institutional Review Board (IRB) and sponsor.
• Contribute to the development of corrective and preventive action plans.

Informed Consent:

• Address barriers to effective informed consent discussions (e.g., literacy, language, distress).
• Abide by institutional policy and processes for informed consent.
• Ensure the use of the most current IRB-approved protocol consent document during patient consent.
• Collaborate with the physician investigator for initial and ongoing consent processes.
• Assess ongoing consent and patient understanding.
• Timely re-consent patients as needed.
• Understand tiered consent processes for optional correlative studies.

Management of Clinical Trial Patients:

• Collaborate with the investigator to assess study patient eligibility.
• Educate patients and families about protocol participation.
• Provide patient education on required study procedures.
• If the Research Coordinator is a Registered Nurse (RN), educate patients about clinical conditions and disease processes. If not an RN, schedule educational time with an RN.
• Identify patients requiring increased nursing assessment and management beyond trial requirements (if an RN).
• Coordinate and schedule protocol-required events (e.g., pharmacokinetics, scans, study visits, quality of life assessments).

Minimum Qualifications:

• Bachelor’s degree in a relevant field (e.g., life sciences, nursing, or pharmacy).
• Current Basic Life Support (BLS) certification.
• Current Texas Registered Nursing License for RNs (if applicable).
• Preferred: Oncology clinical trial experience and research coordination experience.

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