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

MSD•Rahway, NJ

3d•Remote

About The Position

The Senior Clinical Research Associate is accountable for performance and compliance for assigned protocols and sites in 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 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 develops the territory for clinical research by identifying and developing new sites and contributes expertise on monitoring processes and systems in internal meetings and workstreams. The position includes remote and on-site site-management and monitoring activities, site visits, regulatory-document collection and review, site-performance oversight, and collaboration with internal functions and external partners. The CRA maintains study information in CTMS, eTMF, and other systems; contributes to process improvements and team knowledge; supports or leads audits and inspections; and mentors junior CRAs. Domestic and international travel is approximately 65%–75% of working time, expected to be about 2–3 days per week. A current driver’s license is required. South Florida residents are strongly preferred. The position is remote, with the primary posting location listed as Rahway, New Jersey.

Requirements

Fluent Spanish speaking skills.
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 7 years of relevant healthcare-field experience, including at least 4 years of direct site-management (monitoring) experience in bio/pharma/CRO; or a bachelor’s degree or above plus at least 4 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 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-motivation visits designed to boost site enrollment.
Ability to manage complex issues in a solution-oriented manner.
Ability to 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.
High sense of accountability and urgency; ability to set priorities and handle multiple tasks in a changing environment.
Ability to work effectively in a matrix, multicultural environment and establish culturally sensitive working relationships.
Customer-focused approach and commitment to quality and compliance.
Positive and growth mindset; able to work independently and be self-driven.
Professional demeanor and communication consistent with organizational policies and practices.
Ability to travel domestically and internationally approximately 65%–75% of working time, with expected travel of about 2–3 days per week.
Current driver’s license.

Nice To Haves

Candidates residing in South Florida are strongly preferred.

Responsibilities

Develop strong site relationships and maintain continuity of those relationships through all phases of the trial.
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 associated documents.
Develop an in-depth understanding of the study protocol and related procedures.
Coordinate and manage tasks with other sponsor roles to achieve Site Ready.
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 validation, initiation, monitoring, and close-out visits, and prepare clear, comprehensive, accurate visit and non-visit contact reports on time.
Collect, review, and monitor required 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 overall site performance.
Identify, assess, and resolve site-performance, quality, or compliance problems, escalating them as appropriate through the defined CRA Escalation Pathway in collaboration with relevant colleagues.
Work with internal country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, and headquarters functions, as well as vendors, IRB/IECs, and Regulatory Authorities, to support assigned sites.
Manage and maintain information and documentation in CTMS, eTMF, and other appropriate systems within required timelines.
Contribute to CRA team knowledge as a process Subject Matter Expert by sharing best practices, recommending continuous improvements, and providing training as needed.
Support and/or lead audit and inspection activities as needed.
Follow country strategy to identify potential new sites and work with them to develop clinical research capabilities.
Mentor or buddy junior CRAs on process and study requirements and conduct co-monitoring visits where appropriate.
Perform Quality Control visits if delegated by other roles and appropriately trained.