Specialist, Clinical Research Associate (MSD)

Roles and Responsibilities

Responsibilities include, but are not limited to:

• Develops strong site relationships and ensures continuity of site relationships 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 & manages various tasks in collaboration with other sponsor roles to achieve

Site Ready.

• Participates & provides inputs on site selection and validation activities.

• Performs remote and on-site monitoring & oversight activities using various tools to ensure:

o Data generated at site are complete, accurate and unbiased.

o Subjects’ right, safety and well-being are protected.

• Conducts site visits including but not limited to validation visits, initiation visits, monitoring

visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact

reports appropriately in a timely manner.

• Collects, reviews, and monitors required regulatory documentation for study start-up, study

maintenance and study close-out.

• Communicates with Investigators and site staff on issues related to protocol conduct,

recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections

and overall site performance.

• Identifies, assesses and resolves site performance, quality or compliance problems and

escalates per defined CRA Escalation Pathway as appropriate in collaboration with

CRA-Manager, CRM, TA Head and CRD as needed.

• Works in partnership with GCTO country operations, finance, regulatory affairs,

pharmacovigilance, legal and regional operations, HQ functional areas and externally with

vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.

• Manages and maintains information and documentation in CTMS, eTMF and various other

systems as appropriate and per timelines.

• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME),

buddy/mentor and sharing best practices as appropriate/required.

• Supports and/or leads audit/inspection activities as needed.

• Performs co-monitoring visits where appropriate.

• Following the country strategy defined by CRD and/or CRA-Manager, contributes to the

identification of new potential sites and works closely with them to develop strong clinical

research capabilities.

Required Skills:

Accountability, Adaptability, Adverse Event Reporting System, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Reporting, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Protocol Adherence, Regulatory Compliance, Training Team Members