Senior Associate, Operational Excellence

Reposted 10 Days Ago
Hiring Remotely in USA
Remote
Senior level
Other
The Role
The Senior Associate, Operational Excellence will manage site operations, ensure regulatory compliance, lead staff development, and support business growth in clinical research.
Summary Generated by Built In

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 to 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 www.CareAccess.com.

 
How This Role Makes a Difference

We are seeking an experienced clinical research associate to assist with the operations and strategic growth of our clinical research sites. The ideal candidate brings a strong background in clinical research management, regulatory compliance, and team development, with a proven ability to drive operational excellence and foster a culture of quality.  

This role requires a proactive, solutions-oriented professional who can balance day-to-day site operations with long-term business development and staff leadership. The successful candidate will ensure compliance with all applicable regulations, assist with study start-up and enrollment efforts, and cultivate an environment where staff thrive, and studies are executed at the highest standards.  

How You'll Make An Impact
  • Site Operations Management - Assist with daily site activities acting as the primary point of contact for the site, ensuring appropriate staffing, training, and adherence to SOPs. Maintain compliant facilities and equipment.  
  • Leadership & Staff Development: Assist with training and mentoring research staff. Uphold professional development goals and foster a culture of accountability, integrity, and continuous improvement.   
  • Work with Manager, Operational Excellence to ensure high staff morale and low turnover rates 
  • Regulatory & Compliance Oversight: Promote strict adherence to ICH-GCP, FDA, and local regulations, while maintaining audit readiness across all studies.  
  • Assist Manager, Operational Excellence, Operational Compliance, and Quality Assurance Departments with all Care Quality and FDA audits 
  • Business Development: Support feasibility assessments through partnership with Manager, Operational Excellence to ensure timely responses to questionnaires, and scheduling of site qualification visits.  
  • Study Start-Up & Enrollment Oversight: Support with regulatory packet submissions, and site initiation processes. Work with investigators to meet or exceed patient recruitment and retention goals.  
  • Assist with additional projects such as quality improvement initiatives, internal data monitoring ensuring accuracy, integrity, and timely entry of study data, and may represent the site at meetings and industry events.  
The Expertise Required
  • A minimum of 5 years of clinical research experience, with at least 1-2 years in a supervisory or management role. CRC experience a plus.  
  • Hands-on knowledge of ICH-GCP, FDA regulations, and local regulatory requirements.  
  • Demonstrated success in study management, study start-up, patient recruitment, and compliance oversight.  
  • Budget management, business development, or sponsor/CRO engagement experience is a strong plus.   
Certifications/Licenses, Education, and Experience:
  • An equivalent combination of education and direct clinical research leadership experience may be considered in place of formal degrees
  • Preferred: Bachelor’s degree in a health sciences field (e.g., Nursing, Biology, Pharmacology, Public Health, or related discipline).  
  • Minimum of five years Clinical Research experience.  
How We Work Together
  • Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
  • Travel: This role requires up to 50% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. 
    • Type of travel required: National 
  • Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
    • Walking - 10%
    • Standing - 10%
    • Sitting - 80%
    • Lifting up to 25 lbs - as needed
    • Driving - as needed

The expected salary range for this role is $70,000 - $100,000 USD per year for full time team members.

Benefits & Perks (US Full Time Employees)
  • 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
  • 401(k) Retirement Plan, with Company Match 

Diversity & Inclusion

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: [email protected]

Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100. 

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The Company
HQ: Boston, MA
818 Employees

What We Do

Care Access is a leading decentralized research organization (DRO) that breaks down traditional barriers in clinical research for patients, sponsors, and physicians. Its innovative model brings decentralized trials, Sites On Demand™, Virtual PIs, and Mobile Sites to previously-unreachable patient populations to expand the impact of clinical research. Supported by top pharmaceutical and biotech partners across 20 different therapeutic areas, Care Access is scaling and globalizing its new model for clinical trial delivery, where more physicians and patients can engage in life-saving research to develop new therapies faster. To find out how Care Access is transforming the future of clinical trials, visit www.careaccess.com or email [email protected].

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