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Associate Clinical Research Associate
3 weeks ago
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.
- Data generated at site are complete, accurate and unbiased
- Subjects right, safety and well-being are protectedConducts 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 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 co-monitoring where appropriate.
**Competency Expectations**: Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.
Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.
Hands on knowledge of Good Documentation Practices.
Developing skills in Site Management including management of site performance and patient recruitment.
Developing level of monitoring skill and independent professional judgment.
Works with high quality and compliance mindset.
Capable of managing complex issues, solution-oriented approach.
Ability to perform root cause analysis and implement preventative and corrective action.
B.A./B.S. required with strong emphasis in science and/or biology.
Min. 2 years of clinical research experience. Related CR experience.
Search Firm Representatives Please Read Carefully
Regular
Not Applicable
**Requisition ID**: R332376.
**Job skills required**: Finance, English, Research, Compliance
**Job skills preferred**: Biology, Legal
