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Site Management Associate
Location
North Carolina
Posted
5 days ago
Salary
0
Seniority
Mid Level
Job Description
Site Management Associate
WEP Clinical
• Collaborate with Clinical Operations to develop site initiation timelines and ensure adherence to project milestones • Prepare and manage site startup documentation, including contracts, informed consent forms, and regulatory submissions • Coordinate with contracts and budget teams to ensure timely execution of site agreements • Assist with the preparation and submission of essential regulatory documents for site activation • Ensure all documents are approved by ethics committees and IRBs before site activation • Track progress of regulatory submissions, site contracts, and essential document collection • Verify site readiness with adequate resources and completed training prior to patient enrolment • Participate in study kick-off and initiation meetings to align expectations and timelines • Troubleshoot activation issues and escalate problems to the Project Manager or CRA when needed • Assist with the setup of study supplies and equipment at the site, including investigational products and lab kits
Job Requirements
- Bachelor's Degree (in a health or science field preferred)
- 2+ years’ experience in site management, clinical research, or equivalent combination of education, experience, and expertise
- Computer literacy and proficiency in Microsoft Office and clinical systems (e.g., EDC,CTMS, eTMF)
- Effective verbal and written communication skills
- Ability to handle confidential information with complete discretion
- Strong organizational skills and attention to detail
- Ability and willingness to travel up to 20% of the time
- The employee must be able to remain in a stationary position for extended periods.
Benefits
- Medical, dental, and vision insurance
- FSA, HSA
- Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
- Group short-term and long-term disability insurance
- Group Life Insurance
- 401K safe harbor plan and company match
- Paid vacation, holiday, sick and volunteer time
- Paid maternity & paternity leave
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• Being the main point of contact between site personnel and CRA involved in the project helping on query resolution and EDC completion • Serve as the primary site’s contact point for vendors, study supplies, and access management • Ensure that pre-study testing of local site facilities is completed • Assists the Monitors in their prompt completion of all subject event and site event information in CTMS • Track the resolution status of site issues and action items in CTMS • Act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies • Ensure regulatory and ethics committee submissions and notifications • Coordinate preparation for and follow-up on site, TMF and systems' audits and inspections • Manage the TMF on a site and a country level for regularly and file documents • Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists • Arrange and track initial and ongoing project training for site teams in all vendor-related systems • Document Management and translations status review of the study




