The CRA Line Manager supervises the Clinical Research Associates (CRAs) and provides oversight to ensure successful monitoring of projects at MedSource. The CRA Line Manager participates in the interviewing and hiring process, recommends monitoring staffing solutions, and manages the performance, training, and growth opportunities of the CRAs.
DUTIES AND RESPONSIBILITIES:
- Serve as main point of contact for CRAs for any non-project specific needs.
- Manage performance and support training needs and growth opportunities of CRAs.
- Communicate regularly with CRAs to ensure their knowledge, understanding, and compliance with assigned project goals and departmental and corporate strategies and objectives.
- Support Business Development by assisting with resource planning for new projects.
- Participate with the MedSource Executive Management Team to determine and operationalize corporate strategy and vision for the continued growth of MedSource.
- Participate in Clinical Operations-related recruiting, interviewing and hiring.
- Conduct new employee orientation and onboarding.
- Participate in project review meetings with senior management.
- Monitor and/or manage assigned studies as needed according to all applicable SOPs, regulations, and guidelines.
- Perform field visits to assess CRA performance and conduct other visits as needed.
- Assist project teams with coordination of study activities to ensure project deliverables meet sponsor deadlines and ensure all objectives and expectations are fulfilled.
- Work with all operational units to help investigate issues and promote effective resolutions.
- Assist in the development of quality standards and programs.
- Establish strong professional relationships with clients and colleagues by building trust, open communication, and managing day-to day operational issues.
- Provide excellent customer service to both internal and external clients; ensure the same from the CRAs.
- Review and approve weekly timesheets for MedSource tasks.
- Review and approve requests from CRAs for time off.
- Perform other duties as assigned by MedSource senior management.
MINIMUM JOB REQUIREMENTS:
- BA/BS in a Life Science field or commensurate experience.
- Five (5) years of experience in clinical research.
- Prior site monitoring experience.
- Personnel management experience, including performance review, time management prioritization, resource allocation, etc.
- In-depth knowledge and experience of the drug development process including study initiation, clinical monitoring, drug safety, regulatory affairs, data management and analysis, and clinical study report generation.
- Ability to travel approximately 50% both domestically and internationally. Must possess a valid driver’s license, passport, and maintain a personal credit card or have an available line of credit for charging travel expenses.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
- Excellent oral and written communication skills.
- Excellent interpersonal and organizational skills with strong attention to detail.
- Good customer/client relationship management and proactive problem-solving skills.
- Knowledge of the principles, methods, and procedures of clinical research.
- Knowledge of scientific experimental design and methodology and protocol development.
- Knowledge of FDA, ICH and GCP guidelines for the conduct of clinical trials in human subjects.
- Ability to motivate and provide technical leadership, advice, guidance, and direction to all levels of staff.
- Exhibit staff development and performance management skills.
- Ability to analyze and interpret data and prepare evaluative summary reports.
- Ability to develop and deliver presentations.
- Ability to develop and implement clinical research study plans and standard operating procedures.
- Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment (both verbal and written).
- Ability to handle multiple tasks simultaneously, meet rigorous timelines, and work effectively in stressful situations.
- Adapt easily to change and endorse/encourage staff adoption of change.
CONDITIONS OF EMPLOYMENT:
- Verification of educational requirements, employment history, professional references, and certifications/training.
We are committed to diversity in the workplace and are an equal opportunity employer.