Clinical Research Associate (CRA) - Immunology (Remote)

MSD • Rahway, NJ

3d • $96,200 - $151,400 • Remote

About The Position

The Clinical Research Associate (CRA) is accountable for performance and compliance for assigned clinical trial protocols and sites within a country. Under the oversight of the CRA Manager, the role ensures 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 helps expand 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.

This remote role involves domestic and international travel approximately 65%–75% of working time, typically about two to three days per week. Candidates in the Southwest, Northwest, and Rocky Mountain regions (WA, OR, CA, AZ, CO, UT, ID, NM, or MT) are strongly preferred. A current driver’s license is required. The position is based primarily in Rahway, New Jersey, with remote work arrangements.

Requirements

• Fluency in local languages and English, both verbal and written, and strong communication skills, including the ability to understand and present technical information effectively.
• Good understanding and working knowledge of clinical research, clinical trial phases, current GCP/ICH, 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 management of site performance and patient recruitment.
• Strong 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 manage multiple tasks in a changing environment.
• Accountability, urgency, customer focus, quality and compliance mindset, self-direction, and professional demeanor.
• Ability to work effectively in a multicultural matrix environment and maintain culturally sensitive working relationships.
• A current valid driver’s license.
• Associate degree, certificate, or equivalent in a scientific or healthcare discipline and at least five years of relevant healthcare-field experience, including at least two years of direct site management (monitoring) experience in a bio/pharma/CRO; or a bachelor’s degree or above and at least two years of direct site management (monitoring) experience in a bio/pharma/CRO.

Nice To Haves

• Experience in immunology.
• Preferred skills include accountability, adaptability, immunology research, and immunotherapy.
• Candidates located in WA, OR, CA, AZ, CO, UT, ID, NM, or MT are strongly preferred.

Responsibilities

• Develop strong site relationships and maintain continuity of those relationships 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 related documents.
• Develop an in-depth understanding of study protocols and related procedures.
• Coordinate and manage tasks with other sponsor roles 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 site 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 through the defined CRA Escalation Pathway in collaboration with relevant colleagues as needed.
• Partner with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters functional areas, vendors, IRBs/IECs, and regulatory authorities in support of assigned sites.
• Maintain information and documentation in CTMS, eTMF, and other relevant systems within required timelines.
• Contribute to CRA team knowledge as a process subject matter expert, buddy or mentor, and by sharing best practices as appropriate.
• Support or lead audit and inspection activities as needed.
• Perform co-monitoring visits where appropriate.
• Help identify potential new sites according to the country strategy and work with them to develop clinical research capabilities.
• Travel domestically and internationally approximately 65%–75% of working time, typically two to three days per week.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and families.
• Retirement benefits, including a 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

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