Senior Region Manager, Research Empowered Communities-East Region

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 Senior Region Manager for our Research Empowered Communities 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 subjects, CROs and sponsors. The Senior 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:

· 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.

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 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.

Financial:

· 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.

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: 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

Research Empowered Communities

· 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.

Physical and Travel Requirements

· 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

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 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.

Certifications/Licenses, Education, and Experience:

· 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

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

Diversity & Inclusion

We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to 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 value diversity and believe that unique contributions drive our success.

At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to 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.

Employment Statement

Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.