Job OverviewUnder moderate supervision, executes the feasibility, site identification, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional or country level.Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, andreports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes projecttimelines.
With moderate oversight and supervision, perform tasks at a country/region level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines.
May also include maintenance activities.Essential Functions
- Serve as a Single Point of Contact (SPOC) to perform feasibility, site activation, and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs, and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary.
Review documents for completeness, consistency, and accuracy, under the guidance of senior staff.
- Prepare site documents, reviewing for completeness and accuracy.
- Inform team members of completion of regulatory, contractual, and other documents for individual sites.
- Distribute completed documents to sites and internal project team members.
- Update and maintain internal systems, databases, tracking tools, timelines, and project plans with accurate and complete project-specific information.
- Review, track, and follow up on the progress, approval, and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents.
Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.Qualifications
- Bachelor's Degree in Life Sciences or a related field.
- 1 - 3 years of experience in management, negotiation, drafting, and modification of contracts; budget management.
- 3 years of experience in a healthcare environment: CROs or Pharma companies.#J-18808-Ljbffr