Clinical Research Associate (CRA) - Immunology (Remote)

MSD • Rahway, NJ

3d • Remote

About The Position

The Clinical Research Associate (CRA) - Immunology is responsible for the performance and compliance of assigned protocols and sites within a country. This role, under the oversight of the CRA-Manager, ensures that study conduct adheres to ICH/GCP, country regulations, company policies, quality standards, and adverse event reporting requirements. The CRA acts as the primary site contact and manager throughout all phases of a clinical research study, taking overall responsibility for allocated sites. Additionally, the CRA actively develops and expands the territory for clinical research by identifying and developing new sites. The role also involves participating in internal meetings and workstreams as a Subject Matter Expert (SME) for monitoring processes and systems.

Requirements

• Fluent in Local Languages and English (verbal and written).
• 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.
• Associate's degree, certificate or equivalent in a scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field, including at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO.
• OR Bachelor’s degree (or above) together with at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO.
• Current driver’s license required.

Nice To Haves

• Experience in Immunology preferred.
• Candidates located in the Southwest or Northwest (WA, OR, CA or AZ) regions are strongly preferred.

Responsibilities

• Develops strong site relationships and ensures continuity 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 and manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates and provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring and oversight activities using various tools to ensure data accuracy, subject protection, and compliance.
• Conducts site visits (validation, initiation, monitoring, close-out) and records clear, comprehensive, and accurate reports in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, maintenance, and close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, deviations, regulatory documentation, audits/inspections, and site performance.
• Identifies, assesses, and resolves site performance, quality, or compliance problems, escalating as appropriate in collaboration with the CRA-Manager and other stakeholders.
• Works in partnership with various internal and external functional areas (e.g., country operations, finance, pharmacovigilance, regulatory affairs, vendors, IRB/IECs, Regulatory Authorities) in support of assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF, and other systems as appropriate and per timelines.
• Contributes to CRA team knowledge by acting as a process SME, buddy/mentor, and sharing best practices.
• Supports and/or leads audit/inspection activities as needed.
• Performs co-monitoring visits where appropriate.
• Contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities, following the country strategy.
• Manages complex issues, works in a solution-oriented manner, performs root cause analysis, and implements preventative and corrective actions.

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days
• Annual bonus
• Long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree