Job Summary:

Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.

Essential Responsibilities and Duties:

• Under supervision, coordinates aspects of patient involvement for complex and/or multiple studies from study initiation until study completion.
• Organizes research information for clinical trials.
• Observes subjects and assists with data analysis and reporting.
• Schedules the collection of data.
• Reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately.
• Monitors, and reports research data to maintain quality and compliance.
• Performs administrative and regulatory duties related to the study as appropriate.
• Participates in other protocol development activities.
• Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.)
• Educates potential participants and caregivers on protocol specific details and expectations.
• Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).
• Assists Clinical Trial Manager (CTM) with oversight of vendors, accounting, regulatory, client satisfaction, recruitment, quality, and trial outcomes.
• Assists the CTM in planning, creating processes, trainings and development of staff.
• Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.

Education/Experience/Skills:

• High school graduate or equivalent; Bachelors Degree, preferred
• CCRC certification preferred
• 2-3 years of experience in the clinical research field, preferred
• Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials.
• Strong leadership and mentorship skills.
• Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level.
• Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations.