Senior Clinical Research Associate - Cardiovascular (Bilingual-English/Spanish) (Remote)

MSD•Rahway, FL

2d•$129,000 - $203,100•Remote

About The Position

The Senior Clinical Research Associate is accountable for performance and compliance for assigned clinical trial protocols and sites within a country. Under the oversight of the CRA Manager or CRD, the role ensures study conduct complies with ICH/GCP, country regulations, company policies and procedures, quality standards, and adverse event reporting requirements. The Senior CRA serves as the primary site contact and site manager throughout all phases of a clinical research study and takes overall responsibility for allocated sites. The role also helps identify and develop new research sites and contributes subject-matter expertise on monitoring processes and systems. Candidates residing in South Florida are strongly preferred. The position involves domestic and international travel approximately 65%–75% of working time, typically about 2–3 days per week. A current driver’s license is required. The role is remote, with the primary location listed as Rahway, New Jersey, and no relocation offered. Spanish fluency is required, along with English proficiency and strong communication skills. Candidates need either an associate’s degree, certificate, or equivalent in a scientific or healthcare discipline and at least seven years of relevant healthcare experience, including at least four years of direct site monitoring experience in bio/pharma/CRO; or a bachelor’s degree or above and at least four years of direct site monitoring experience in bio/pharma/CRO. The salary range for the primary location is $129,000–$203,100. The successful candidate will be eligible for an annual bonus and long-term incentive, if applicable. Benefits include medical, dental, vision, and other insurance benefits for employees and families, retirement benefits including a 401(k), paid holidays, vacation, and compassionate and sick days.

Requirements

Fluent Spanish speaking skills are required.
Fluency in local languages and English, verbally and in writing, with excellent communication skills and the ability to understand and present technical information effectively.
Associate’s degree, certificate, or equivalent in a scientific or healthcare discipline, plus at least seven years of relevant healthcare experience, including at least four years of direct site management/monitoring experience in bio/pharma/CRO; alternatively, a bachelor’s degree or above and at least four years of direct site management/monitoring experience in bio/pharma/CRO.
Excellent understanding and working knowledge of clinical research, clinical trial phases, current GCP/ICH, and applicable country clinical research laws and guidelines.
Excellent understanding of global and country/regional clinical research guidelines and ability to work within them.
Demonstrated ability to mentor and lead.
Hands-on knowledge of Good Documentation Practices.
Proven site management skills, including independent management of site performance and patient recruitment.
Demonstrated high-level monitoring skills and independent professional judgment.
Good IT skills, including MS Office and clinical IT applications on computers, tablets, and mobile devices, and ability to adapt to new applications and devices.
Ability to understand and analyze data and metrics and act appropriately, including in a virtual environment.
Experience conducting site motivational visits intended to boost site enrollment.
Ability to manage complex issues in a solution-oriented manner, perform root cause analysis, and implement preventive and corrective actions.
Effective time management, organizational, interpersonal, conflict management, and problem-solving skills.
Ability to work independently across multiple protocols, sites, and therapy areas; prioritize and handle multiple tasks in a changing environment; and demonstrate accountability and urgency.
Ability to work effectively in a multicultural matrix environment and establish and maintain culturally sensitive working relationships.
Customer-focused approach, high-quality and compliance mindset, positive and growth mindset, self-direction, and professional demeanor consistent with organizational policies and practices.
Ability to travel domestically and internationally approximately 65%–75% of working time, typically about 2–3 days per week.
Current driver’s license required.

Nice To Haves

Candidates residing in South Florida are strongly preferred.

Responsibilities

Develop strong site relationships and maintain continuity of those relationships throughout all trial phases.
Perform clinical study site management and monitoring in compliance with ICH-GCP, sponsor SOPs, local laws and regulations, the protocol, the Site Monitoring Plan, and related documents.
Develop an in-depth understanding of study protocols and associated procedures.
Coordinate and manage tasks with other sponsor roles to achieve site readiness.
Participate in and provide input to site selection and validation activities.
Conduct remote and on-site monitoring and oversight to ensure site data are complete, accurate, and unbiased and that subjects’ rights, safety, and well-being are protected.
Conduct site visits, including validation, initiation, monitoring, and close-out visits, and complete clear, accurate visit and non-visit contact reports on time.
Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out.
Communicate with investigators and site staff about protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, audits and inspections, and site performance.
Identify, assess, and resolve site performance, quality, or compliance problems, escalating them through the defined CRA pathway as appropriate and in collaboration with relevant colleagues.
Partner with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters functions, vendors, IRBs/IECs, and regulatory authorities in support of assigned sites.
Maintain information and documentation in CTMS, eTMF, and other systems according to applicable timelines.
Contribute to CRA team knowledge as a process subject-matter expert by sharing best practices, recommending improvements, and providing training as appropriate.
Support or lead audit and inspection activities as needed.
Help identify potential new sites under the country strategy and work with them to develop clinical research capabilities.
Mentor or buddy junior CRAs on processes and study requirements and conduct co-monitoring visits when appropriate.
Perform quality control visits when delegated by other roles and appropriately trained.