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Clinical Site Manager
5 hours ago
Job Summary
The Clinical Site Manager is responsible for the overall management of the life of a clinical trial, overseeing the work of Study Coordinators and Clinical Research Nurses to ensure efficiency and success of the applicable trial.
Key Responsibilities
Team Leadership and Coordination
Supervise and mentor Study Coordinators and Clinical Research Nurses
Provide training and ensure all staff is familiar with the study protocol, ethical guidelines, and safety requirements
Foster effective communication among all stakeholders
Clinical Responsibilities
Be the expert on assigned trials; understanding and implementing the protocol.
Create study timelines and execution planning (IP delivery, lab kits, etc)
Involved in all study planning - monitor communications, attending IM + SIV, approving source creation (paper and electronic)
Be able to act as the backup to the coordinators
Serve as primary escalation and contact for resolution of issues that arise throughout trial for both internal and external teams
Regulatory Responsibilities
Managing internal greenlight process - ensuring all training and delegations are appropriately signed and completed, collaborating with regulatory
Maintain all appropriate documentation throughout the trial
Ensure all invoiceables are captured correctly for studies
Work with QA to evaluate root-cause analysis of CAPA's
Educational Responsibilities
Collaborate with new clinical staff to ensure adequate development of CRN's/SC's
Be a resource and educator for all coordinators
Qualifications
Strong team leadership and management skills
Strong verbal and written communication skills
Strong interpersonal and customer service skills
Strong organizational skills and attention to detail
Strong time management skills with a proven ability to meet deadlines
Strong analytical and problem-solving skills
Ability to prioritize tasks and to delegate them when appropriate
Ability to function well in a high-paced environment
Education and Experience
Bachelor's or Associates degree in health or science related field required
BSN Preferred
3-5 years of experience in clinical research, with at least 2 years in a managerial role overseeing clinical studies or trials
