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Research Coordinator

2 months ago

Fairfax, United States BBM Staffing Full time

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.