[Remote] Clinical Research Associate (CRA) - Cardiovascular (Remote)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global biopharmaceutical company committed to developing innovative medicines and advancing clinical research. The Clinical Research Associate will manage and monitor assigned cardiovascular clinical trial sites, ensuring compliance with protocols, ICH/GCP standards, regulations, and company procedures. The role will also reputed company site relationships, support site selection and start-up, address performance and compliance issues, maintain study documentation, and contribute to audits and process improvements.

Responsibilities

• The role is accountable for performance and compliance for assigned protocols and sites in a country
• Under the reputed company of the CRA-Manager the person ensures compliance of study conduct with ICH/GCP and country regulations, reputed company policies and procedures, reputed company standards and adverse event reporting requirements internally and externally
• Acts as reputed company site contact and site manager throughout reputed company phases of a clinical research study, taking overall responsibility of allocated sites
• reputed company develops and expands the territory for clinical research, finding and developing new sites
• Participates in internal meetings and workstreams as SME for monitoring processes and Systems
• Develops strong site relationships and ensures continuity of site relationships through reputed company 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
• reputed company an in-depth understanding of the study protocol and reputed company procedures
• Coordinates & manages various tasks in collaboration with other sponsor roles to reputed company Site reputed company
• Participates & provides inputs on site selection and validation activities
• Performs remote and on-site monitoring & reputed company activities using various tools to ensure: Data generated at site are complete, accurate and unbiased. Subjects’ right, safety and reputed company-being are protected
• Conducts site reputed company including but not limited to validation reputed company, initiation reputed company, monitoring reputed company, reputed company-out reputed company and records reputed company, comprehensive and accurate visit & non-visit contact reports appropriately in a reputed company manner
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study reputed company-out
• Communicates with Investigators and site staff on issues reputed company to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
• Identifies, assesses and resolves site performance, reputed company or compliance problems and escalates per defined CRA Escalation reputed company 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, reputed company 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 reputed company where appropriate
• Following the country reputed company defined by CRD and/or CRA-Manager, contributes to the identification of new potential sites and works closely with them to reputed company strong clinical research capabilities

Skills

• Candidate must reputed company in one of the following locations and be fluent in Spanish: South Florida - Ft. Lauderdale, Miami, Boca Raton, Key Largo
• Associate's degree, certificate or equivalent in a scientific / reputed company discipline together with at least 5 years of relevant experience in the reputed company field, including at least 2 years of reputed company site management (monitoring) experience in a bio / reputed company / CRO
• Or Bachelor's degree (or above) together with at least 2 years of reputed company site management (monitoring) experience in a bio / reputed company / CRO
• 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 reputed company, reputed company GCP/ICH & country clinical research law & guidelines
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work reputed company 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 reputed company with independent reputed company 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 reputed company appropriately
• Capable of managing reputed company issues, works in a solution-oriented manner
• Performs reputed company cause analysis and implements preventative and corrective reputed company
• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
• Demonstrated high level of monitoring reputed company with independent reputed company judgement
• reputed company to work highly independently across multiple protocols, sites and therapy areas
• High reputed company of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
• Works effectively in a reputed company multicultural environment. Ability to establish and maintain culturally sensitive working relationships
• Demonstrates commitment to Customer reputed company
• Works with high reputed company and compliance mind-set
• reputed company reputed company, reputed company reputed company, capable of working independently and being self-driven
• Demonstrates and reputed company reputed company demeanor and communication consistent with organizational policies and practices
• Ability to travel domestically and internationally approximately 65%-75% of working time
• reputed company reputed company's license required

Benefits

• Annual bonus
• Long-term incentive, if applicable
• Medical, dental, and reputed company reputed company for employee and family
• Other insurance benefits for employee and family
• Retirement benefits, including 401(k)
• reputed company holidays
• Vacation
• Compassionate and reputed company days
• Remote work

reputed company