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 CThe 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 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.
Min Bachelor’s degree, preferably in the sciences or health related field. The ideal candidate will have at least 5 years of field monitoring experience and a minimum of 5 years of industry or related research experience. Candidate must have detailed knowledge of FDA regulations and GCP/ICH guidelines as they apply to the conduct of clinical research. Ability to travel on a regular basis for regional management responsibilities and relationship management with sites, sponsors and vendors is a requirement. Working knowledge of Microsoft Office Suite. Excellent written and verbal communication skills are required in order to effectively communicate to a wide variety of audiences including senior management. Must possess excellent mentoring and supervisory skills in order to build a staff that works as a team, delivering uniform product to each sponsor.
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.
We are considering remote-based candidates for this opening. Home/Remote office experience is required.
TKL Research, Inc. - 21 months ago