CRA Manager

United States

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Job Description

TKL Research is a full-service, international Clinical Research Organization (CRO) serving the pharmaceutical, biotechnology, medical device and consumer healthcare industries. We provide comprehensive clinical trial management services for Phase 1-4 clinical research studies, including an inpatient Phase 1 facility and outpatient specialized research clinics.

We are seeking a highly motivated CRA Manager for our growing organization!

The CRA Manager is responsible for managing clinical monitoring activities in a team oriented environment as determined by the project and TKL SOPs. Works with the Directors of Clinical Monitoring and Monitoring Quality and the Project Managers to assure clinical monitoring performance standards are consistent across all projects. Responsible for assigning study visits to each CRA, and forecasting and meeting the monitoring requirements according to the work scope. The CRA Manager is also responsible for communicating to appropriate TKL personnel any needs, issues, and problems on a regular basis.

Responsibilities include, but are not limited to:

Supervises team of CRAs to assure consistency and compliance in monitoring of clinical investigations.
Ensure project timelines are met in conjunction with Project Manager. Serves as a resource, along with Project Manager, to CRAs to assist in trouble shooting at research sites.
Perform field evaluation visits and/or hands-on training with CRAs, as needed to ensure high quality monitoring.
Track time allocation for CRAs to ensure accountability, productivity and efficiency, via review of timecards, itineraries, expense accounts, and site visit grouping.
Maintain general knowledge of study protocols and procedures to which CRAs are assigned.
Communicate regularly with the Project Managers on the status of CRA assignments, performance, needs, tasks and all other relevant issues.
Initiate regular CRA communication and meetings.
Attend project related internal and client meetings, as appropriate.
Provide appropriate training, as necessary, for CRAs in job-related activities (eg, SOPs, processes, travel policies & accountability, GCPs, and other relevant regulatory information) to ensure CRAs are kept current.
Participate in departmental process and performance improvement activities.
Create and implement tools to track and report on the quality and efficiency of CRAs.
Work with Director, Clinical Monitoring to provide input regarding performance management and salary administration, disciplinary actions and other related tasks concerning employee evaluations and performance.
Miscellaneous duties, as necessary, in support of Clinical Monitoring initiatives and TKL business priorities and objectives.

Skills/Requirements

Minimum Bachelor’s degree; health sciences field preferred. Ideal candidate will have at least 5 years field monitoring experience and a minimum 5 years of industry experience. Must possess detailed knowledge of FDA regulations and GCP/ICH guidelines as they apply to the conduct of clinical research. The CRA Manager will have the ability to anticipate and solve problems while analyzing complex issues and environments. Must be willing and able to travel on a regular basis for regional management responsibilities and relationship management with sites, sponsors, and vendors. Proficiency in Microsoft Office is required. Must also possess excellent mentoring and supervisory skills in order to build a staff that works as a team delivering uniform product to each sponsor. We are considering remote-based candidates for this opening. Home/Remote office experience is required. This is a full-time opportunity.

We offer a competitive compensation package for full time employees, commensurate with your background and experience, including full benefits, 401(k) with match and a profit sharing plan.

www.tklresearch.com