- Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance.
- Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines.
- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
- Proactively manage sites to ensure timely site activation and escalate study issues appropriately and in a timely fashion.
- Participate in team meetings to progress trials and identify site issues that might impact the timelines.
- When needed, assist in preparation of Site Activation project specific plans and provide accurate projections and timelines to study teams agreed with the Sponsor Review and customize country and site specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolve informed consent issues and other potential difficulties with study sites.
- Liaise with Covance Regulatory department regarding document submission requirements, if applicable.
- Prepare submissions to IRB/IEC, and regulatory authorities if Global Regulatory Services (GRS) requires input. Liaise with applicable IRB/IEC and/or regulatory authorities (if applicable) regarding submission/ approval issues. Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time.
- May support the negotiation of site contracts and budgets with sites, if applicable andtrack progress of contract and budget milestones/developments, intervening and escalating as appropriate.
- Undertake tasks delegated by senior team members, depending upon country and situational requirements.
- Perform other duties as assigned by management.
Level of education preferred (if required or experience level which may be substituted for level of education).
Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM etc.).
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
- In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered.
- Minimum of 2 years of experience in clinical development or start up/ regulatory process.
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites.
- Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them.
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