Clinical Research Coordinator

Job Summary

• Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies.
• Participates in study budget negotiations and reconciles study budget accounts.
• Develops informational materials for recruitment of subjects. Monitors enrollment goals and modifies recruitment strategy as needed.
• Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately. Prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary). Prepares regulatory documents for sponsor.
• Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews. Performs subject interviews and assessments for data required by protocol(s).
• Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.).
• Reviews incoming subject adverse event (SAE) information, assists Principal Investigator (PI) in making submission determination of SAEs, and follows up to determine resolution of adverse events.
• Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply).
• Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
• Stays up to date with knowledge of regulatory affairs and/or issues.

Qualifications

Required

• Bachelor's degree in science or a health-related field and 2 years of clinical research experience. OR
• Associate's degree in science or a health-related field and 3 years of clinical research experience.

Preferred

• Society of Clinical Research Associates (SOCRA) /Association of Clinical Research Professionals (ACRP) Clinical Research Certification upon date of hire.

Required Skills

• Demonstrates analytical skills.
• Ability to simultaneously handle multiple priorities.
• Possesses strong technical aptitude.
• Demonstrates a high commitment to quality.
• Excellent organizational skills.