Clinical Research Manager

Brandon, FL
Full Time
Experienced

Clinical Research Manager 

Location: On-Site – Bay Area Cardiology & Vascular Associates (BACA), part of the Cardiovascular Associates of America (CVAUSA) Research Network 

Organization: Bay Area Cardiology & Vascular Associates (BACA) 

At Bay Area Cardiology & Vascular Associates (BACA), we’re advancing cardiovascular care through research that truly changes lives. As part of the Cardiovascular Associates of America (CVAUSA) national network, we bring together clinical excellence, cutting-edge innovation, and the shared mission to make every study count. 
 
We’re seeking a Clinical Research Manager—a strategic, hands-on leader who can guide our research team, champion quality and compliance, and help grow one of the region’s most dynamic cardiovascular research programs. 

The Role 

As the Clinical Research Manager, you’ll oversee the daily operations of BACA’s clinical research program, leading a team of 4–5 talented coordinators and regulatory professionals. You’ll set the tone for excellence in patient care, regulatory compliance, and operational execution. 
 
This role blends leadership and innovation—you’ll implement research technology (including REALTIME-CTMS, eSource, and eRegulatory systems), standardize processes, and work closely with CVAUSA’s central research leadership to expand study volume, strengthen sponsor relationships, and ensure consistent performance across all trials. 

What You’ll Do 

  • Lead the team: Manage, mentor, and develop a team of 4–5 study coordinators and regulatory staff, fostering collaboration, accountability, and professional growth. 

  • Drive quality and compliance: Oversee adherence to ICH-GCP, FDA, IRB, and CVAUSA policies, ensuring every trial meets the highest ethical and operational standards. 

  • Oversee regulatory excellence: Supervise IRB submissions, essential document maintenance, and reporting of deviations, violations, and safety events (AEs/SAEs). 

  • Implement technology: Lead the rollout and optimization of REALTIME-CTMS, eSource, and eRegulatory systems, creating efficient, paperless workflows that enhance data quality and oversight. 

  • Cultivate partnerships: Collaborate with sponsors, CROs, and CVAUSA network teams to ensure smooth study activation, communication, and monitoring. 

  • Grow the program: Identify opportunities to expand the site’s research portfolio, improve efficiency, and enhance enrollment capabilities across cardiovascular trials. 

  • Ensure audit readiness: Establish systems and conduct internal quality reviews to maintain ongoing inspection readiness and data integrity. 

  • Support operations: Step in as needed to assist with study coordination activities, maintaining a practical understanding of day-to-day trial execution. 

Metrics of Success 

  • Growth in active clinical trials and patient enrollment across the research program. 

  • Audit readiness and quality metrics demonstrating compliance with GCP, FDA, and IRB standards. 

  • Implementation and adoption of REALTIME-CTMS, eSource, and eRegulatory solutions across the site. 

  • Staff engagement and retention rates reflecting effective leadership and team development. 

  • Sponsor and CRO satisfaction scores based on communication, responsiveness, and site performance. 

  • Timely and accurate reporting of safety events, deviations, and essential document updates. 

  • Achievement of annual goals for new study activations, startup timelines, and operational efficiency. 

What We’re Looking For 

  • 5+ years of experience in clinical research coordination and/or regulatory management, preferably within cardiovascular or specialty medical research. 

  • Proven leadership experience managing research staff or site teams. 

  • Strong understanding of ICH-GCP, FDA regulations, IRB processes, and sponsor communication practices. 

  • Experience implementing or managing Clinical Trial Management Systems (CTMS) and eSource/eRegulatory solutions; REALTIME-CTMS experience highly preferred. 

  • Exceptional communication, problem-solving, and organizational skills. 

  • A forward-thinking mindset—someone who leads by example, embraces innovation, and thrives in a growing, fast-paced research environment. 

Ideal Experience 

  • Previous role as a Lead Coordinator, Regulatory Lead, or Site Research Manager with multi-study oversight. 

  • Hands-on experience training and mentoring research staff. 

  • Experience supporting sponsor audits, monitoring visits, and regulatory inspections. 

  • Familiarity with private practice or physician-owned research environments. 

  • Success implementing technology solutions that streamline operations and improve compliance. 

Why BACA & CVAUSA 

At BACA, you’ll lead with purpose—empowering your team to deliver research that saves lives. Backed by the strength of the CVAUSA Research Network, you’ll have access to national expertise, shared resources, and the support needed to take our program to the next level. 

✨ This isn’t just management. This is leadership that shapes the future of cardiovascular research—right here at BACA, powered by CVAUSA.

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