Associate Clinical Research Associate

2 weeks ago


Midrand, Gauteng, South Africa MSD Full time

Brief Description of Position


With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.

- 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 indepth 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 onsite monitoring & oversight activities using various tools to ensure:
  • 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, closeout visits and records clear, comprehensive and accurate visit & nonvisit contact reports appropriately in a timely manner.
  • Collects, reviews, and monitors required regulatory documentation for study startup, study maintenance and study closeout.
  • 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.
  • Supports audit/inspection activities as needed.
  • Performs comonitoring where appropriate.

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Valid Driving License:

Hazardous Material(s):

Requisition ID:
R248089

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