Research Coordinator
Research Coordinator Job Description
Position : Research Coordinator
Location : Irving, TX
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 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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