Senior Clinical Research Coordinator

The Senior Clinical Research Coordinator (CRC) oversees and administers clinical research studies and associated activities. This position will support multiple research projects under the MIRROR program.

Responsibilities

Oversees and administers clinical research studies and associated activities; assists with development and management of study budgets; reviews protocol requirements and collects impact statements to assign costs to assessments/procedures; provides feedback on time necessary for conduct staff to administer assessments/procedures; cooperates with Geneva Corporate Manager to ensure studies remain financially healthy; assists in project planning and ensures pre-established work scope, study protocol, and regulatory requirements are followed; recruits and coordinates research subjects as appropriate; serves as principal administrative liaison for the project; oversees and coordinates administrative and staff services to investigators; develops and maintains record keeping systems and procedures; promotes safety and confidentiality of research participants; adheres to OSHA, GCP, GLP, and infection control procedures; plans and coordinates initiation of research study protocol and implementation of operating policies and procedures; plans, implements, and maintains data collection and analysis systems; organizes and facilitates meetings, conferences, and events; documents correspondence and communication pertinent to research; interacts and communicates with Principal Investigator, site personnel, research participants, The Geneva Foundation, and funding organization; creates and adheres to a data quality and quality assurance plan; assists with interim and annual reports; serves as primary liaison at data collection site; maintains regulatory documentation for IACUC/IRB and communications with sponsor or Federal/regulatory office; manages study budgets; cooperates with institutional compliance and monitoring efforts; coordinates and facilitates monitoring and auditing visits; notifies PI and institutional officials of external audits and inspections; may manage CRCs, research assistants, and conduct team members; assists with staffing, hiring, salary negotiations, and performance reviews; oversees programmatic/study related conduct; ensures sponsor and Geneva enrollment/milestones, study execution, and monitoring expectations are met

Requirements

Bachelors degree or equivalent work experience required; US Citizenship required to work at this government site; Demonstrated competence in oral and written communication; Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor; Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner; Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software; Knowledge of CFR, GCP and ICH guidelines

Nice to have

Masters degree preferred; 8 years' experience in clinical research preferred; 5+ years non-profit, research, or healthcare experience desired; Certified Clinical Research Coordinator (CCRC) certification preferred