What are the responsibilities and job description for the Senior Research Coordinator position at Amavita Research Services LLC?
Company Description Amavita Research Services LLC is a GCSA-certified (2026–2029), ICH-GCP E6 (R3) compliant cardiovascular clinical research site based in Miami, FL, conducting Phase 1–4 trials for global biopharma and medical device sponsors. The site is led by Principal Investigator Dr. Pedro Martinez-Clark, MD, FACC, Chief Medical Officer Dr. William W. O'Neill, MD, FACC, a pioneer of TAVR in the United States, and Chief Operating Officer Nereisy Alonso, an experienced coordinator of industry-sponsored cardiovascular trials. Amavita offers disciplined study start-up, rapid patient enrollment through its CardioElite referral network, and hands-on trial coordination across EDC, IWRS/IRT, and payment reconciliation systems. A bilingual English/Spanish team supports inclusive screening, informed consent, and retention of South Florida’s diverse patient population, helping sponsors meet diversity-in-trials commitments. Core therapeutic areas include heart failure, acute coronary syndromes, hypertension, peripheral artery disease, structural heart disease (including TAVR), and cardiovascular imaging.
Role Description The Senior Research Coordinator is a contract, on-site role based in Miami, FL, responsible for coordinating cardiovascular clinical trials from start-up through close-out. This role manages day-to-day study operations, including patient screening, informed consent, scheduling, visit coordination, data collection, and documentation in alignment with protocol, ICH-GCP, and site SOPs. The Senior Research Coordinator will complete and maintain source documents, enter data into EDC systems, manage queries, support safety reporting, and prepare for monitoring visits, audits, and inspections. This position collaborates closely with investigators, sub-investigators, nursing staff, and sponsors/CROs to ensure protocol adherence, enrollment targets, and high-quality data. Additional responsibilities include supporting IRB submissions, maintaining regulatory binders, training junior staff, and contributing to process improvements that enhance study timelines and participant experience.
Qualifications
- Strong Research and Data Collection skills, including experience with source documentation, EDC platforms, and query resolution.
- Advanced Analytical Skills to interpret protocols, lab results, and study data, and to identify protocol deviations and trends.
- Effective Communication skills for interacting with participants, investigators, site staff, sponsors/CROs, and external partners.
- Working knowledge of Institutional Review Board (IRB) processes, including submissions, amendments, continuing reviews, and safety reporting.
- Prior experience (typically 3–5 years) as a clinical research coordinator or similar role, preferably in cardiology or related therapeutic areas.
- Thorough understanding of ICH-GCP, FDA regulations, and clinical trial conduct in