Sr. Spclst, Clinical Research

Job Description

The role is accountable for performance and compliance for assigned protocols and sites in a

country.

Under the oversight of the CRA-Manager or CRD the person ensures compliance of study

conduct with ICH/GCP and country regulations our ogaization policies and procedures quality

standards and adverse event reporting requirements internally and externally.

Acts as primary site contact and site manager throughout all phases of a clinical research study

taking overall responsibility of allocated sites.

Actively develops and expands the territory for clinical research finding and developing new

sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.

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 internally 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 strongly to CRA team knowledge by acting as process Subject Matter Expert

(SME) sharing best practices making recommendations for continuous improvement and

providing training as appropriate/required.

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

Following the country strategy defined by CRD and CRA-Manager contributes to the

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

research capabilities.

Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring

visits where appropriate.

Could perform Quality control visits if delegated by other roles and trained appropriately.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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