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.