What We Do
Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position Overview
The Region Manager assumes overall responsibility for the management of sites assigned. This individual’s responsibility spans the entire functionality of the sites to include personnel management, site profitability and the successful conduct of all studies while providing a high-quality point of intersection for staff, study participants, CROs and sponsors. The Region Manager provides leadership and oversight of site operations according to CARE SOPs, GCP and FDA/ICH Guidelines
What You'll Be Working On
Duties include but not limited to:
Personnel:
· 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)
o Ensure all training is up to date
· Conduct weekly 1:1 meeting with each direct report
o Review performance and KPIs
o 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
New Staff:
· Review potential candidates and conduct interviews for all roles within assigned region and provide timely feedback
· Onboard new employees at all assigned sites.
o Complete the new hire checklist for each new employee
o Meet with new employees daily during their first week of employment to review expectations and progress on assigned training
o Meet all new employees on site during their first week of employment.
o Ensure all Care Access training is complete prior to requesting study specific training
o Provide additional training resources, if applicable
Management of Studies and Site Workload:
· 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
Quality:
· 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
Financial:
· 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.
o Decrease hourly staff when appropriate
o Apply coverage when short staffed
Site Maintenance:
· 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
Community Engagement:
· 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.
Physical and Travel Requirements
· Candidates must be willing to travel up to 50% of the time nationwide. Frequency and length of travel may depend on the length and project requirements
Knowledge, Skills, and Abilities:
· Excellent working knowledge of medical and research terminology Must have a client service mentality
· Excellent working knowledge of federal regulations, good clinical practices (GCP)
· Ability to communicate and work effectively with a diverse team of professionals
· Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments
· Communication Skills: Strong verbal and written communication skills
· Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals
· Strong computer skills with demonstrated abilities using clinical trials database, IWRS, electronic data capture, MS word and excel
· Ability to balance tasks with competing priorities
· Critical thinker and problem solver
· Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done
· Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
· High level of self-motivation, energy and possess a high degree of urgency.
· Ability to work independently in a fast-paced environment with minimal supervision
· Ability to adapt to frequent changes in responsibilities and workloads.
Certifications/Licenses, Education, and Experience:
· Bachelor’s Degree preferred, or equivalent combination of education, training and experience.
· A minimum of 1+ years of relevant management experience
· A minimum of 3+ years prior Clinical Research Coordinator experience required
· 2 years’ experience as a Care Access Research Clinical Research Coordinator is preferred
Benefits (US Full-Time Employees Only)
PTO/vacation days, sick days, holidays.
100% paid medical, dental, and vision Insurance. 75% for dependents.
HSA plan
Short-term disability, long-term disability, and life Insurance.
Culture of growth and equality
401k retirement plan