Clinical Research Coordinator III - Cardiology

About the Role

This position serves as a Clinical Research Coordinator III (CRC Lead), responsible for project allocation and immediate oversight of clinical research coordinators and clinical research associates, along with primary coordination of assigned studies. The role includes managing schedules, improving research systems and processes, training personnel, and resolving day-to-day administrative and operational problems to ensure successful implementation of research protocols.

Responsibilities

• Provide immediate oversight of the CRC team, including project allocation, staff scheduling, and staff training; contribute to performance reviews for the CRC team.
• Identify and ensure needed resources and logistics for research activities, including determining appropriate courses of action to solve day-to-day research operations problems.
• Handle departmental reporting related to protocol activity, accrual data, workload, and other research information; present this information to management.
• Participate in project feasibility reviews and study initiation visits; provide strategic guidance on study set-up and implementation.
• Identify quality and performance improvement opportunities; collaborate with staff to develop action plans to improve quality and efficiency.
• Provide oversight for institutional, pharmaceutical, and internal audits, including facilitating third-party study monitoring and designing corrective actions.
• Assist with research project budget development, including identifying and classifying routine care vs. research-related care; assist with research participant billing and reconciliation.
• Coordinate assigned projects, including patient screening and consenting, regulatory reporting, data collection, maintenance of source documents, and facilitation of study logistics to ensure successful protocol implementation and patient safety.
• Attend meetings and conferences related to research activities, including research staff meetings.
• Participate in planning, workshops, evaluation meetings, and seminars as necessary or requested.

Requirements

• Bachelor’s degree in a related field is required; Master’s degree is preferred.
• SoCRA or ACRP certification within one (1) year of hire.
• Basic Life Support (BLS) certification from the American Heart Association is required.
• Phlebotomy Certification (CPT) from CDPH is preferred.
• Certified Registered Medical Assistant is preferred.
• Five (5) years of clinical research coordination or related experience is required.
• Maintain comprehensive knowledge of all departmental research protocols to ensure compliant execution of studies in accordance with governing entity requirements (e.g., Sponsor, FDA, IRB).

Skills

• Ability to use software applications and operate technological devices (e.g., computer, laptop, tablet, smartphone).
• Act as a team lead, overseeing the work of others, assigning tasks, and ensuring completion according to deadlines and quality standards.
• Establish effective working relationships with cross-functional teams.
• Collaborate to problem-solve and make decisions to achieve desired outcomes.
• Respond timely, effectively, and appropriately to deliverables.
• Share knowledge, time, and expertise to assist other team members.
• Cultivate and maintain strong customer relationships and rapport with stakeholders and/or client groups.
• Identify and respond appropriately to both internal and external customer needs using available resources.
• Represent the company with external constituents.

Physical Demands

• Able to perform moderate lifting.
• Able to sit, stand, and walk for prolonged periods of time.
• Able to read papers and online documents.
• Able to operate standard office equipment.
• Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.