Clinical Research Associate (CRA) - Immunology (Remote)

Merck•Rahway, NJ

8d•$96,200 - $151,400•Remote

About The Position

The Clinical Research Associate (CRA) is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA-Manager, the CRA ensures that study conduct complies with ICH/GCP, country regulations, company policies and procedures, quality standards, and internal and external 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 clinical research territory by identifying and developing new sites, and participates in internal meetings and workstreams as a subject matter expert for monitoring processes and systems. The CRA builds strong, continuous site relationships; manages and monitors sites in accordance with applicable requirements; and conducts remote and on-site oversight to support accurate, complete, and unbiased data and protect subjects’ rights, safety, and well-being. The role includes site selection and readiness activities, site visits, regulatory-document management, communication with investigators and site staff, issue resolution and escalation, and collaboration with internal functions, vendors, ethics committees, and regulatory authorities. The CRA maintains study information in CTMS, eTMF, and other systems, contributes expertise and mentoring to the CRA team, and supports or leads audits and inspections as needed. The position is remote, with candidates in the Southwest or Northwest (Washington, Oregon, California, or Arizona) strongly preferred. Domestic and international travel is approximately 65%–75% of working time, typically 2–3 days per week. A current driver’s license is required. The role is regular employment and offers a salary range of $96,200–$151,400, with eligibility for an annual bonus and long-term incentive, if applicable.

Requirements

Fluency in local languages and English, both verbal and written, with excellent communication skills and the ability to understand and present technical information effectively.
Good understanding and working knowledge of clinical research, clinical trial phases, current GCP/ICH requirements, and country clinical research laws and guidelines.
Understanding of global and country/regional clinical research guidelines and ability to work within them.
Hands-on knowledge of Good Documentation Practices.
Proven site management skills, including site performance management 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.
Ability to understand and analyze data and metrics and act appropriately.
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; set priorities; and handle multiple tasks in a changing environment.
Ability to work effectively in a multicultural matrix environment and establish culturally sensitive working relationships.
Customer focus, a strong quality and compliance mindset, accountability, urgency, a positive and growth mindset, self-direction, and professional demeanor.
Associate’s degree, certificate, or equivalent in a scientific or healthcare discipline and at least 5 years of relevant healthcare-field experience, including at least 2 years of direct site management (monitoring) experience in a bio/pharma/CRO; or a bachelor’s degree or above and at least 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.
Current driver’s license.
Ability to travel domestically and internationally approximately 65%–75% of working time, with expected travel of 2–3 days per week.

Nice To Haves

Experience in immunology.
Immunology research or immunotherapy experience.
Candidates located in the Southwest or Northwest, specifically Washington, Oregon, California, or Arizona, are strongly preferred.
Accountability and adaptability.

Responsibilities

Develop strong site relationships and ensure continuity throughout all phases of a 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 study protocols and related procedures.
Coordinate and manage tasks with sponsor colleagues to achieve site readiness.
Participate in and provide input to site selection and validation activities.
Perform 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 complete timely, clear, comprehensive, and accurate visit and non-visit contact reports.
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, resolve, and appropriately escalate site performance, quality, or compliance problems 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.
Manage and maintain information and documentation in CTMS, eTMF, and other systems within required timelines.
Contribute to CRA team knowledge as a process subject matter expert, buddy, or mentor, and share best practices.
Support and/or lead audit and inspection activities as needed.
Perform co-monitoring visits where appropriate.
Contribute to identifying potential new sites and developing their clinical research capabilities in accordance with country strategy.
Participate in internal meetings and workstreams as a subject matter expert for monitoring processes and systems.