Are you ready to be a part of breakthrough research? The Clinical Research Coordinator III (CRC Lead) is responsible for project allocation and immediate oversight of clinical research coordinators and clinical research associates, along with primary coordination of assigned studies. This includes managing schedules and coverage for the coordinator team, improving efficiency of research systems and processes, training of personnel, and resolution of day-to-day administrative and operational problems to ensure the successful implementation of research protocols.
Primary Duties and
Responsible for immediate oversight of CRC team, including project allocation, staff scheduling and staff training; contributes to performance reviews for CRC team. Identifies and ensures needed resources and logistics for research activities, including determining appropriate course of action in solving day-to-day research operations problems. Responsible for departmental reporting related to protocol activity, accrual data, workload, and other research information; present this information to management.
Participates in project feasibility reviews and study initiation visits and provides strategic guidance on study set-up and implementation. Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality and efficiency. Provides oversight for institutional, pharmaceutical and internal audits, including facilitating third party study monitoring and designs and implements needed corrective actions.
Provides assistance with research project budget development, including identifying and classifying routine care vs. research related care and provides assistance with research participant research billing and reconciliation. Provides study coordination for assigned projects, including patient screening and consenting, regulatory reporting, completion required data collection, maintenance of source documents, facilitation of all study logistics to ensure successful protocol implantation and patient safety.
Attend meetings and conferences related to research activities, including research staff meetings. Participate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested.
Bachelor's degree in a related field is required. Master's degree is preferred. Licenses and
SoCRA or ACRP certification within one (1) year of hire. Basic Life Support (BLS) from the American Heart Association is required. Phlebotomy Certification (CPT) from CDPH is preferred.
Certified Registered Medical Assistant is preferred. Experience and
Five (5) years of clinical research coordination or related experience is required. Maintains comprehensive knowledge of all departmental research protocols to ensure the compliant execution of studies in accordance with research governing entity requirements, including but not limited to Sponsor, FDA and IRB requirements. Ability to use software applications and operate technological devices (e.g., computer, laptop, tablet, smartphone, etc.
Acts as a team lead to include overseeing the work of others, assigning or allocating work to team, and ensuring tasks are completed according to deadlines and quality standards. Establishes effective working relationships with cross-functional team(s) Collaborates to problem solve and make decisions to achieve desired outcomes Responds timely, effectively and appropriately to deliverables Shares knowledge, time and expertise to assist other members of the team Cultivates and maintains strong customer relationships and rapport with stakeholders and/or client groups Identifies and responds appropriately to both internal and external customer needs utilizing available resources Represents 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.