The base salary range for this position is $170,000 - $190,000.
What you will be Doing
Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:
- Coordinate site management activities:
- Site identification, recruitment, and selection.
- Regulatory document collection and review.
- Overall scheduling and management of all site visits.
- Develop site/monitoring tools and training materials.
- Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.
- Coordinate and oversee daily operations of clinical monitoring team:
- Set and enforce project timelines with the assigned study team.
- Coordinate remote review of clinical data within EDC system.
- Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract.
- Review and approve trip reports and follow-up letters within required timeframe.
- Manage quality and regulatory compliance among clinical monitoring team and investigational sites.
- Manage project milestones and proactively address deficiencies
Manage CRA performance:
- Define and implement functional standards, goals, and expectations with clinical monitoring team.
- Serve as CRA mentor and perform accompanied field assessment visits as required.
- Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.
- Documentation Duties/Responsibilities:
- Assure that the appropriate SOPs are followed.
- Ensure all project documentation is appropriately filed per SOPs.
- Assist PM in preparation of audit responses, as appropriate.
- Thorough knowledge of clinical research process.
- Strong communication skills (verbal and written) to express complex ideas.
- Excellent organizational and interpersonal skills.
- Ability to manage multiple priorities within various clinical trials.
- Ability to reason independently and recommend specific solutions in clinical settings.
- Understanding of basic data processing functions, including electronic data capture.
- Working knowledge of current ICH GCP guidelines and applicable regulations.
- Ability to work independently, prioritize and work with a matrix team environment is essential.
- Prior experience in electronic data capture (EDC) preferred.
- Able to mentor CRAs and more junior Clinical Trial Managers.
- BS/BA (or equivalent) in one of the life sciences and a minimum of 4 years direct experience in clinical studies
- Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis
- Minimum of 5 years as a successful Lead CRA or Clinical Trial Manager.