Region Manager

Title: Region Manager-Florida

Location: Remote, US

Type: Full Time - Regular

Workplace: remote

Category: IRO: US Site Network

Job Description:

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

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 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.