- tart-up (from site identification through pre-initiation)
Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during start-up phase.
- Build relationships with investigators and site staff
- Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include: Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments. Conduct remote Qualification Visits (QVs)
- Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
- Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
- Prepare and submit IRB/IED and MoH/RA (if applicable) applicant(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
- Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy
- Forecast, develop, manage, and revise plans and strategies for: IRB/IEC and MoH/RA submission/approval, Site activation, Patient recruitment & retention
- Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
- Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
- Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
- Ensure that assigned sites are audit and inspection ready
- Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
- Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.
- Show commitment and perform consistent high quality work.
- Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.
- Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
- Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.
- Provide input and feedback for Performance Development Conversation(s).
- Proactively keep manager informed about work progress and any issues.
- Develop expertise to become a subject matter expert.
- Work in a self-driven capacity, with limited need for oversight.
- Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)
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