Senior Region Manager, Research-Empowered Communities

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 up to sites in an assigned geography. 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 Regional 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:

The Senior Region Manager, Research Empowered Communities (REC), will be responsible for:

· Overall ownership of Clinical Operations at REC sites: Including P&L ownership of REC sites, Enhanced stakeholder management of Principal Investigators, relevant REC-specific external and internal stakeholders, inclusive of Clinical Research Coordinators at the site. As needed direct Liaison to Community contacts.

· Leading and proactively managing a team: Set goals and objectives for the team in alignment with KPIs. Manage team performance, ensuring continuous feedback, support, and coaching are provided. In partnership with the Director of Site Conduct, interview and hire new staff members as needed. Liaise with the Training Manager to train and onboard new team members and ensure all annual training and documentation is up to date.

· Ensure active management of studies and site workload and maintenance: In partnership with Investigator(s), evaluate and determine feasibility of upcoming opportunities/protocols. Liaise with appropriate stakeholders to ensure site, coordinator, study, and sponsor needs are met in terms of staff coverage, vendor support, site maintenance, and timely study start-up and activation of new trials in line with established and regulatory guidelines/requirements as applicable. Ensure QC/QA of key materials and reports, and work with the QA team and site teams to address any issues that may arise, including coordinating the creation of CAPA plans as required for complete and timely execution. Responsible for planned revenue generation of each site within the assigned region. Review protocols to identify needed outsourcing procedures and plan for and communicate any upcoming staffing needs to the Director of Site Conduct.

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work expected and are not necessarily all-inclusive.

Physical and Travel Requirements

· Travel requirements will be as needed, up to 50% of the time nationwide. Frequency and length of travel may depend on site level activities (e.g., Site Evaluation Visits, etc.)

· No significant lifting.

What You Bring

· Knowledge, Skills and Abilities:

o Excellent working knowledge of medical and research terminology. 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:

o 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. Must have a client service mentality.

Certifications/Licenses, Education, and Experience:

· Bachelor’s Degree preferred, or equivalent combination of education, training and experience

· A minimum of 1 year of relevant management experience

· A minimum of 3 years prior Clinical Research Coordinator experience

· 1 year of experience as a Care Access Research Clinical Research Coordinator Preferred.

· RN or LPN preferred.

· Research Professional Certification- CCRP/CCRC 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

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.