Lead Clinical Research Coordinator

Lead Clinical Research Coordinator (260000C7)

This role independently leads and oversees day‑to‑day operations of clinical research studies conducted by a principal investigator with minimal supervision. The coordinator develops knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and FDA regulations. Supervision of limited staff is possible.

Minimum Education

• B.A./B.S. in a science, technical, health‑related field or applicable discipline with at least 5 years of relevant research experience.
• Master’s degree with at least 4 years of relevant research experience.
• Doctor of Philosophy (Ph.D.) … with at least 2 years of relevant research experience.

Minimum Work Experience

• At least five years of experience with a bachelor’s degree.
• At least four years of experience with a master’s degree.
• At least 2 years of relevant research experience with a doctoral degree.

Required Skills / Knowledge

• Knowledge of clinical research designs and necessary infrastructure.
• Familiarity with databases, data collection tools and data analysis methods.
• Ability to manage multiple complex activities while maintaining attention to detail.
• Interpersonal skills that demonstrate formal and informal leadership in a diverse professional environment.

Required Licenses and Certifications

• Internal candidates:
  Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA), Certified Clinical Research Associate through the Association of Clinical Research Professionals (ACRP), or equivalent research certification. (Required on hire)
• External candidates:
  Certification as a CCRP through SoCRA or equivalent within one year of hire. (Required)

• Consistently demonstrates adherence to the standards for the responsible conduct of research.
• Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
• Stays informed of and adheres to institutional policies, and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidances (International Council on Harmonization) regarding human subjects’ research and use of protected health information.
• Uses research funds and resources appropriately.
• Maintains confidentiality of data as required.
• Meets all annual job‑related training and compliance requirements.

• Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.
• Accurately creates, completes, maintains and organizes study documents.
• Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.
• Uses and accounts for research funds and resources at performance level, including reconciling research subject billing.
• Works well with other members of the research team and seeks and provides input when appropriate.
• Serves as an effective liaison between the investigators, sponsors, hospital departments involved in research studies and the Clinical Research Center.
• Adheres to the IRB‑approved recruitment plan.
• Screens subjects for eligibility per the protocol and institutional policies.
• Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.
• Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.
• Engages participants/LARs in the informed consent process according to institutional policies.

• Conducts/participates in feasibility assessments to ensure adequate site resources and infrastructure are available for protocol participation.
• Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member.
• Ensures regulatory integrity of protocols…