Clinical Research Site Director

4 dni temu

Warszawa, Mazovia, Polska Care Access Pełny etat
Job Overview
Care Access is a pioneering organization that revolutionizes access to clinical trials for the benefit of patients everywhere. As a clinical research site director, you will be responsible for overseeing the day-to-day activities at our site under the direction of the Country Manager. Your primary objective will be to ensure delivery of enrollment goals while maintaining adherence to local regulations and CARE SOPs in all aspects of conducting clinical trials.

Responsibilities
  • Meet with team members face-to-face (at least monthly): Ensure regular site meetings with clear communication pathways are in place, and skip level meetings with Warsaw site staff to ensure 360 feedback and communication regarding the site performance and management.
  • Interview and hire new staff members as needed: Collaborate with Training Manager to train/onboard new site employees, as well as ensure completion of new employee paperwork and processes, and work with site staff to set up a training plan based on prior experience.
  • Ensure HR policies are implemented and maintained at all sites.
  • Participate in annual performance appraisals and have goal setting and milestone meetings regularly throughout the year with Warsaw site employees to discuss progress.
  • Assure that all staff are up to date on annual training and documentation is in their record.
  • Encourage a positive team-oriented environment.
  • Lead by example and display a high level of integrity and professionalism.
  • Collaborate with Investigator(s) to evaluate and determine feasibility of upcoming opportunities/protocols.
  • Coordinate Investigator and Sub-Investigator coverage.
  • Work with Country Manager to identify outside vendors and set up agreements.
  • Access and adjust distribution of studies to coordinators to best meet site, coordinator, study, sponsor needs.
  • Maintain relationships with physicians' network that create expansion opportunities (PIs, Sub-Is, doctor referrals).
  • Assure study required training has been completed by staff and PI in a timely manner as to not delay study start-up.
  • Update Country Manager on all pending and active study details.
  • Oversee all CRC's work to ensure data is entered in a timely manner, all queries answered, training is complete, and accesses are obtained on a timely basis.
  • Create and implement processes that will enhance and improve workflow, minimize deviations, minimize no-shows, to benefit overall functionality at each site in the region.
  • Attend all study audits and play an active role in their management and execution of follow-up items.
  • Ensure recruitment activities are optimized, and all studies are meeting their study enrollment goals.
  • Work closely with the Country Manager to ensure timely responses to feasibility questionnaires and scheduling of Site Evaluation Visits as appropriate.
  • Perform a thorough review of protocols for needed outsourcing procedures and unusual procedures that require an increase in costs/time of staff to complete.
  • Keep Country Manager informed of any study changes and all study-related issues that affect the revenue generation at the site.
  • Work with CARE management to identify and communicate staff needs as appropriate.
  • Keep Country Manager apprised of any site maintenance issues.
  • Ensure site is kept clean and organized: Professional for subjects and sponsor/CRO representatives.
  • Ensure that staff are following guidelines and SOPs as pertain to the sites.
  • Ensure that site has the equipment necessary to safely perform job responsibilities.
  • Work with the Country Manager to review and address injury reports if necessary.
  • Ensure the lab follows IATA guidelines and applicable staff are properly certified.
  • Collaborate and communicate with other departments regarding inter-site issues.

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