Remote Region Manager

Summary

Join our team as a Region Manager at Care Access, where you'll oversee site operations, personnel management, and study conduct while providing a high-quality point of intersection for staff, study participants, CROs, and sponsors.

Responsibilities

• Travel to each site within the region and meet with team members (including PI) face-to-face (quarterly at minimum)
• Conduct regular site and Region team meetings
• Meet with PI regularly (bi-weekly at minimum)
• Ensure all training is up to date
• Conduct weekly 1:1 meeting with each direct report
• Review performance and KPIs
• Ongoing employee development and mentoring
• Maintain appropriate documentation for each direct report
• Provide timely evaluation of areas needing improvement and assist in developing a plan for improvement with staff member with objective measurable goals
• Escalate issues appropriately to ensure they are addressed in a timely manner. Engage HR and Director of Site Operations if necessary
• Carry out disciplinary process as required
• Manage underperformance proactively
• Work with HR to implement Performance Improvement Plan (PIP) if necessary to clearly outline the path to employee success
• Conduct annual performance appraisals and have goal setting and milestone meetings regularly throughout the year with employees to discuss progress
• Ensure HR policies are implemented and maintained at all sites
• Ensure that all staff are up to date on annual training and documentation is in their record
• Encourage a positive team-oriented environment at each site in the region
• Ensure high staff morale and low turnover rates
• Ensure time sheets are reviewed and submitted in the required timeframe for non-exempt employees
• Review all travel and expense requests to ensure they are within policy prior to approval
• Work with the Director of Site Operations to review and address injury reports if necessary
• Review potential candidates and conduct interviews for all roles within assigned region and provide timely feedback
• Onboard new employees at all assigned sites
• Complete the new hire checklist for each new employee
• Meet with new employees daily during their first week of employment to review expectations and progress on assigned training
• Meet all new employees on site during their first week of employment
• Ensure all Care Access training is complete prior to requesting study specific training
• Provide additional training resources, if applicable
• Collaborate with Investigator(s) to evaluate and determine feasibility of upcoming opportunities/protocols
• Review protocols to anticipate special needs regarding staff (unblinded, assessors) procedures, outside services and/or costs
• Ability to perform the duties of a Clinical Research Coordinator and actively performs CRC responsibilities at sites
• Coordinate Investigator and Sub-Investigator coverage
• Attend Site Evaluation Visits, Site Initiation Visits in person or remotely
• Regularly assess and adjust workload for site staff to ensure the success of each study
• Work closely with the Study Start Up Team to ensure timely study start-up and activation of new trials
• Ensure study required training has been completed by staff and PI
• Update Director, Site Operations on all pending and active study details
• Be available as a resource to provide expertise on protocols
• Work closely with internal recruitment and marketing teams to ensure recruitment activities are optimized for all studies
• Regularly review metrics for all sites in the region and ensure information is accurate and study goals are being met
• Ensure source is reviewed timely for all new studies
• Oversee all CRC’s work to ensure QC is performed, data is entered, and all queries are resolved in a timely manner
• Create and implement processes that will enhance and improve workflow; minimize deviations, minimize no-shows, benefit overall functionality at each site in the region. Work with Director of Site Operations as processes may be implemented at other locations
• Participate in all internal and external audits; play an active role in their management
• Work directly with the site teams to address items on monitoring reports and Care internal audit reports in a timely manner
• Ensure all Quality Issues at the sites are reported via QMS timely
• Work closely with Operational Compliance and Quality Assurance teams; participate in Root Cause Analysis (RCA) and ensure timely execution of all required actions
• Maintain a calendar of all monitoring visits (including internal audits)
• When possible, meet with CRAs during their monitoring visits (remotely or in person)
• Routinely review all monitoring follow-up letters for action items and quality trends; ensure timely completion of all action items
• Work closely with the Business Development team to ensure the timely responses to feasibility questionnaires and scheduling of Site Evaluation Visits as appropriate
• Keep Director of Site Operations apprised of any study changes and all study related issues that affect the revenue generation at the sites
• Ensure the proper maintenance of participants W-9s to support annual 1099 filings
• Coordinate site staff to cover workload at each site
• Decrease hourly staff when appropriate
• Apply coverage when short staffed
• Keep Director of Site Operations apprised of any site maintenance issues
• Coordinate building and equipment maintenance
• Ensure sites are kept clean and organized
• Region safety resource- knowledgeable on applicable state and federal regulations/OSHA fostering a safe work environment for all staff. Ensure all staff are following OSHA guidelines
• Ensure that sites have the equipment necessary to safely perform job responsibilities
• Review monthly checklists submitted for each site. Ensure there are no lapses in equipment calibration
• Regularly assess space needs and work closely with Director, Site Operations to identify new/additional space, if needed
• Oversee and actively participate in new site builds and decommission of sites
• Develop Partnerships with local providers and community leaders
• Coordinate and participate in community events and patient education considering Care’s diversity initiative in each region