Location: Remote, US

  

Employment Type: Full Time - Regular

  

Team: IRO: US Site Network

  

 **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 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.



 **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

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.

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

\- 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.

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.

·       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.





 **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 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 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 currently unable to sponsor work visas.



  

