Clinical Research Associate (CRA) - Neurology (Remote)

Merck•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 trial protocols and sites in 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, taking overall responsibility for allocated sites. The role also develops the territory for clinical research by finding and developing new sites, and participates in internal meetings and workstreams as a subject matter expert for monitoring processes and systems. The CRA develops strong site relationships, manages and monitors sites in accordance with applicable guidelines and study documents, and conducts remote and on-site oversight to ensure accurate, complete, unbiased data and protection of subjects’ rights, safety, and well-being. The position collaborates with sponsor functions, vendors, IRBs/IECs, regulatory authorities, investigators, and site staff; maintains study information and documentation in CTMS, eTMF, and other systems; and may contribute to audits, inspections, co-monitoring, mentoring, and process improvement. The role is remote, with candidates in the Southeast region (GA, FL, AL, MS, LA) strongly preferred. Domestic and international travel is approximately 65%–75% of working time, with an expected 2–3 travel days per week. Experience in Neurology is preferred.

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, and applicable country clinical research laws and guidelines.
Good 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.
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 and work 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 accountability and urgency; ability to prioritize and handle multiple tasks in a changing environment.
Ability to work effectively in a multicultural matrix environment and maintain culturally sensitive working relationships.
Customer focus, a strong quality and compliance mindset, a positive and growth mindset, self-direction, and professional conduct and communication.
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.

Nice To Haves

Experience in Neurology.
Candidates located in the Southeast region (GA, FL, AL, MS, LA) are strongly preferred.
Current driver’s license preferred.

Responsibilities

Develop strong site relationships and ensure 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, protocols, site monitoring plans, and associated 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 validation, initiation, monitoring, and close-out visits, and complete clear, comprehensive, and accurate visit and non-visit contact reports promptly.
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, and resolve site performance, quality, or compliance problems, escalating them through the defined CRA Escalation Pathway as appropriate and 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.
Maintain information and documentation in CTMS, eTMF, and other systems as appropriate and within timelines.
Contribute to CRA team knowledge as a process subject matter expert, buddy, or mentor, and share 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 country strategy and work with them to develop clinical research capabilities.
Participate in internal meetings and workstreams as a subject matter expert for monitoring processes and systems.