Clinical Research Associate (CRA) - Immunology (Remote)

MSD•Rahway, NJ

4d•$96,200 - $151,400•Remote

About The Position

The Clinical Research Associate (CRA) is accountable for performance and compliance for assigned clinical research protocols and sites in a country. Under the oversight of the CRA-Manager, the CRA 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, taking overall responsibility for allocated sites. The role also develops and expands 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 position is remote. Candidates in the Southwest, Northwest, and Rocky Mountain regions (WA, OR, CA, AZ, CO, UT, ID, NM, or MT) are strongly preferred. Travel domestically and internationally is approximately 65%–75% of working time, typically about 2–3 days per week. A current driver’s license is required.

Requirements

Fluency in local languages and English, verbally and in writing, 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, and applicable country clinical research laws and guidelines.
Good understanding of global and country/regional clinical research guidelines and the 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 Microsoft Office and clinical IT applications on computers, tablets, and mobile devices, and the ability to adapt to new applications.
Ability to understand and analyze data and metrics and act appropriately.
Ability to manage complex issues, work in a solution-oriented manner, perform root cause analysis, and implement preventative 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.
Strong accountability and urgency; ability to prioritize and handle multiple tasks in a changing environment.
Ability to work effectively in a multicultural matrix environment and establish culturally sensitive working relationships.
Customer-focused approach and a strong quality and compliance mindset.
Positive and growth mindset; self-driven and able to work independently.
Professional demeanor and communication consistent with organizational policies and practices.
Associate 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.
Ability to travel domestically and internationally approximately 65%–75% of working time, typically 2–3 days per week.
Current driver’s license.

Nice To Haves

Experience in immunology.
Accountability.
Adaptability.
Immunology research.
Immunotherapy.

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.
Gain 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.
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 promptly record clear, comprehensive, and accurate visit and non-visit contact reports.
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 site performance.
Identify, assess, and resolve site performance, quality, or compliance issues; escalate them through the defined CRA Escalation Pathway in collaboration with relevant colleagues as appropriate.
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 applicable systems in accordance with timelines.
Contribute to CRA team knowledge as a process subject matter expert and buddy or mentor, and share best practices as appropriate.
Support or lead audit and inspection activities as needed.
Perform co-monitoring visits where appropriate.
Follow the country strategy defined by the CRD and/or CRA-Manager to identify potential sites and develop their clinical research capabilities.