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Clinical Research Associate
hace 3 meses
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 the person ensures compliance of study conduct with ICH/GCP and country regulations, our 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.
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 regulations, 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: o Data generated at site are complete, accurate and unbiased. o Subjects' right, safety and wellbeing 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 Escalation Pathway as appropriate in collaboration with leadership as needed.
- Works in partnership with country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, headquarter functional areas and externally with vendors and Regulatory Authorities in support of assigned sites.
- Manages and maintains information and documentation in various other systems as appropriate and per timelines.
- Contributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required.
- Supports and/or leads audit/inspection activities as needed.
- Performs comonitoring visits where appropriate.
- Following the country strategy defined by Clinical Research Director and/or Clinical Reseach Associates manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
Experience Requirements:
Required:
- Min. 2 years of direct site management (monitoring) experience
Educational Requirements:
Preferred:
B.A./B.S. with strong emphasis in science and/or biology
Search Firm Representatives Please Read Carefully
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:
R235255
