Clinical Research Associate; CRA - Cardiovascular; Remote

Position: Clinical Research Associate (CRA) - Cardiovascular (Remote)
** Job Description*
* ** CANDIDATE MUST RESIDE IN ONE OF THE FOLLOWING LOCATIONS AND BE FLUENT IN SPANISH**  **:
South Florida - Ft. Lauderdale, Miami, Boca Raton, Key Largo*
* + The role is accountable for performance and compliance for assigned protocols and sites in a country.

+ Under the oversight of the CRA-Manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

+ Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

+ Actively develops and expands the territory for clinical research, finding and developing new sites.

+ Participates in internal meetings and work streams as SME for monitoring processes and

+ Systems.

** Responsibilities include, but are not limited to:*
* + Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

+ Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.

+ Gains an in-depth understanding of the study protocol and related procedures.

+ Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

+ Participates & provides inputs on site selection and validation activities.

+ Performs remote and on-site monitoring & oversight activities using various tools to ensure:

+ Data generated at site are complete, accurate and unbiased.

+ Subjects' right, safety and well-being are protected.

+ Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.

+ Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

+ Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

+ Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed.

+ Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.

+ Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.

+ Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.

+ Supports and/or leads audit/inspection activities as needed.

+ Performs co-monitoring visits where appropriate.

+ Following the country strategy defined by CRD and/or CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

** Extent of Travel:*
* + Ability to travel domestically and internationally approximately 65%-75% of working time.

+ Expected travelling ~2-3 days/week.

+ Current driver's license required.

** CORE Competency Expectations:*
* + Fluent in Spanish and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.

+ Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

+ Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

+ Hands on knowledge of Good Documentation Practices.

+ Proven Skills in Site Management including management of site performance and patient recruitment.

+ Demonstrated high level of monitoring skill with independent professional judgment.

+ Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.

+ Ability to understand and analyze data/metrics and act appropriately.

+ Capable of managing complex issues, works in a solution-oriented manner.

+ Performs root cause analysis and implements preventative and corrective action.

** Behavioral Competency Expectations:*
* + Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.

+ Demonstrated high level of monitoring skill with independent professional judgement.

+ Able to work highly independently across multiple protocols, sites and therapy areas.

+ High sense of…