Senior Region Manager
24 days ago
Boston
Job Description About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit . How This Role Makes a Difference The Senior 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 Senior Region Manager provides leadership and oversight of site operations according to CARE SOPs, GCP and FDA/ICH Guidelines. The Senior Region Manager serves as a cross functional team lead and is an expert resource for all Region Managers. How You'll Make An Impact • 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), • 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, • Mentor and train new Region managers; be a resource to all RMs and liaison between Leadership, Physicians and RM team, • Region motivator and morale builder; work with Director of Site Operations to develop and implement incentive programs for staff to foster interdepartmental collaboration, teamwork, motivation and excellent participant experience., • 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., • 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, • 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, • Represent Site Network on new projects, • Conduct weekly Site Network Leadership meetings, • 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, • Work closely with Director, Site Operations to review site P&L and make adjustments as needed, • 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, • 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, • Development and implementation of strategic recruitment and targeted community outreach, • Meet regularly with existing community and provider partners to ensure understanding of current studies at their local site. Assist with identifying eligible patients based on inclusion/exclusion criteria, • Order and maintain marketing materials for the patient population for each partner/site., • Develop a strategy for each site to promote site growth and expansion including developing new partnerships of motivated potential community members., • Work cross functionally to develop and onboard new physician partners to include PI's, Sub-I's and Trial Access Partners. Ensure investigators are being paid appropriately. The Expertise Required, • 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 workloadsCertifications/Licenses, Education, and Experience:, • Bachelor's Degree preferred, or equivalent combination of education, training and experience., • A minimum of 2+ 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, • 1 year experience as a Care Access Region Manager is preferredHow We Work Together, • Location: Remote within the United States. This role requires up to 50% travel., • Travel: 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., • Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.Benefits & Perks, • Paid Time Off (PTO) and Company Paid Holidays, • 100% Employer paid medical, dental, and vision insurance plan options, • Health Savings Account and Flexible Spending Accounts, • Bi-weekly HSA employer contribution, • Company paid Short-Term Disability and Long-Term Disability We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to:
Cleaning
Driver & Delivery
Kitchen Porter
Chef & Cook
Waiters
Construction & Trades
Security
Fast Food
Salon & Beauty
Office & Admin
Retail
Sales & Marketing
Warehouse
Customer Service
Host & Hostess
Barista
Entertainment
Accounting & Finance
Animal Care
Art, Media, Design
Bar Staff
Child Care
Education
Engineering
Events & Promotion
Fashion
Healthcare
Information Technology
Legal
Management
Manufacturing
Online Jobs
Science
Sports & Wellness
Writing & Editing
Other
Page 13