Clinical Research Associate, Cardiovascular

This is a fully remote position, open to applicants in Florida, +1 more state.

📋 Description

• Establishes robust relationships with site personnel and ensures the continuity of these relationships throughout all stages of the trial.

• Conducts management and monitoring activities for clinical study sites, adhering to ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documentation.

• Acquires a thorough understanding of the study protocol and related procedures.

• Coordinates and oversees various tasks in partnership with other sponsor roles to ensure Site Ready status.

• Engages in and contributes to site selection and validation processes.

• Executes both remote and on-site monitoring and oversight activities utilizing various tools to ensure:

• Data produced at the site are complete, accurate, and impartial. The rights, safety, and well-being of subjects are safeguarded.

• Performs site visits, including but not limited to validation visits, initiation visits, monitoring visits, and close-out visits, while accurately documenting clear and comprehensive visit and non-visit contact reports in a timely manner.

• Gathers, reviews, and oversees required regulatory documentation for study initiation, maintenance, and closure.

• Communicates effectively with Investigators and site staff regarding protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.

• Identifies, evaluates, and resolves issues related to site performance, quality, or compliance, escalating as necessary according to the defined CRA Escalation Pathway, in collaboration with the CRA-Manager, CRM, TA Head, and CRD when needed.

• Collaborates with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, and regional operations, as well as HQ functional areas and external vendors, IRB/IECs, and Regulatory Authorities in support of assigned sites.

• Manages and maintains information and documentation in CTMS, eTMF, and other relevant systems as required and within specified timelines.

⛳️ Requirements

• Minimum of 5 years of relevant experience within the healthcare sector.

• At least 2 years of direct experience in site management (monitoring) in a bio/pharma/CRO environment.

• Associate's degree, certificate, or equivalent in a scientific or healthcare field OR a Bachelor's degree (or higher).

• Proficient in both Spanish and English (verbal and written).

• Solid understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH guidelines, and country-specific clinical research laws.

• Practical knowledge of Good Documentation Practices.

• Demonstrated skills in Site Management, including the management of site performance and patient recruitment.

• Proficient IT skills (experience with MS Office and various clinical IT applications on computers, tablets, and mobile devices).

• Ability to comprehend and analyze data/metrics and respond appropriately.

• Capable of handling complex issues and works with a solution-oriented approach.

🏝️ Benefits

• Medical coverage.

• Dental insurance.

• Vision healthcare and additional insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate leave and sick days.