What are the responsibilities and job description for the Clinical Site Manager position at Rochester Clinical Research?
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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
- 3-5 years of experience in clinical research, with at least 2 years in a managerial role overseeing clinical studies or trials
Salary : $90,000 - $95,000
