Care Access · 4 hours ago
Senior Region Manager, Research Empowered Communities
United States
Full-time
Remote
Mid, Senior Level
3+ years exp
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No H1B
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Responsibilities
Travel to each site within the region and meet with team members face-to face (every 6-8 weeks or as needed)
Ensure regular site meetings with clear communication pathways are in place.
Conduct weekly 1:1 meetings with each direct report to review performance and KPIs.
Interview and hire new staff members as needed
Collaborate with Training Manager to train/orient new site employees, as well as ensure completion of new employee paperwork and processes
Work with site staff to set-up training plan based on prior experience
Ensure HR policies are implemented and maintained at all sites
Do annual performance appraisals and have goal setting and milestone meetings regularly throughout the year with employees to discuss progress
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 if necessary and provide appropriate HR documentation of any personnel issues and counseling
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
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
Review office operations to ensure compliance with current policies and procedures
Oversee and manage office relations to ensure high staff morale and low turnover rates
Ensure payroll is submitted accurately and in the required timeframe for non-exempt employees
Lead by example and display high level of integrity and professionalism
Approve staff Brex card usage.
Collaborate with Investigator(s) to evaluate and determine feasibility of upcoming opportunities/protocols
Review protocols to anticipate special needs regarding 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 when able with Investigator pre-study visits with sponsor/CRO for upcoming studies
Work with financial team to identify outside vendors and set-up agreements
Access and adjust distribution of studies to coordinators to best meet site, coordinator, study, sponsor needs
Work 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 in a timely manner
Update Director of Site Operations on all pending and active study details
Be available as a resource to provide expertise on protocols and in clinical assessments, and as a stand-in/back-up for employees as needed
Review study stats of sites in the region and ensure information is accurate and study goals are being met
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. Work with Regional Director as processes may be implemented at other locations
Perform QC/QA of study materials at each site within region and work with QA team on any issues that may arise
Work directly with the site teams to address items on monitoring reports and CARE QA reports
Attend all study audits and play an active role in their management and execution of follow up items
Coordinate the creation of CAPA plans as required and ensure their full and timely execution
Participate in community events and patient recruitment initiatives
Ensure recruitment activities are optimized and all sites in the region are meeting their study enrollment goals
Maintain calendar of each sites CRA visits
When possible, meet with all study CRAs during their monitoring visits to ensure all study needs are being met at each region site
Routinely review all monitoring follow-up letters for action items and quality trends.
Responsible for planned revenue generation for each site in the region
Works closely with the Business Development team to ensure the timely responses to feasibility questionnaires and scheduling of Site Evaluation Visits as appropriate
Work with budget and contract personnel. Perform a thorough review of protocols for new outsourcing procedures and unusual procedures that require increase in costs/time of staff to complete
Ensures that all subject compensation trackers are kept up to date and data entered within 24 hours from visit completion
Keep Director of Site Operations appraised of any study changes and all study related issues that affect the revenue generation at the sites
Oversee the monthly reconciliation of stipend payouts
Ensure the proper maintenance of subjects W-9s to support annual 1099 filings
Work with CARE management to identify and communicate staff needs as appropriate
Report site needs to the Director of Site Operations as needed
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: Professional for subjects and sponsor/CRO representatives
Ensure staff are following OSHA guidelines as pertain to the sites
Ensure that site have the equipment necessary to safely perform job responsibilities
Work with the Director of Site Operations 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
Weekly communication with existing community and physician partners to ensure understanding of current studies at their local site. Assisting to identify eligible patients based on inclusion/exclusion criteria.
Ordering and maintaining marketing materials for the patient population for each partner/site.
Community engagement and education- Coordinate and participate in community events and patient education considering Care’s diversity initiative in each region. Train site staff on these events as well.
Develop strategy for each site to promote site growth and expansion including developing new partnerships of motivated potential community members.
Work with Physician and Site Alliance team to develop and onboard new physician partners to include PI’s, Sub-I’s and Trial Access Partners. Ensure investigators are being paid appropriately.
Review and approve what studies are brought to each site based on community feedback.
Assist in coordinating site builds, remodeling/updates, and decommissioning of sites.
Candidates must be willing to travel up to 75% of the time nationwide. Frequency and length of travel may depend on the length and project requirements.
Qualification
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Required
Bachelor’s Degree preferred, or equivalent combination of education, training and experience.
A minimum of 1+ years of relevant work experience as a clinical research manager required
A minimum of 3+ years prior Clinical Research Coordinator experience required
A minimum of 2 years’ experience as a Care Access Research Clinical Research Coordinator
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 as evidenced by positive interactions with coworkers, management, clients, and vendors
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, IVR systems, 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 changes in responsibilities and workloads
Benefits
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
Company
Care Access
Care Access is a global research site that accelerates the availability of new treatments by enabling more communities to gain access clinical research.
501-1,000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Biomedical Advanced Research and Development Authority (BARDA)
2024-08-26Grant· undefined
Leadership Team
A
Ahmad Namvargolian
CEO & Co-Founder
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