Job Overview
Under 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, and reports 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 project timelines. 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
- With moderate oversight and supervision, serve a Single Point of Contact (SPOC) to perform site maintenance, amendment, and site support activities, with involvement in site activation activities as needed,
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 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 the progress, the 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.
- Manage ongoing study maintenance activities throughout the study lifecycle, including protocol amendments, site updates, essential document maintenance, and implementation of sponsor-driven changes.
- Support site budget and contract negotiation activities, including review, preparation, tracking, and coordination with investigative sites and sponsors to facilitate timely study start-up and amendment implementation.
- Coordinate and manage IRB/EC submissions and maintenance activities, including initial submissions, amendments, in accordance with local regulatory requirements and site procedures.
- Partner with investigators, site personnel, sponsors, and internal stakeholders to proactively identify and resolve start-up, regulatory, and maintenance issues that may impact study timelines.
- Maintain effective relationships with investigative sites and act as a key contact to support site engagement, issue escalation, and timely completion of start-up and maintenance deliverables.
- Monitor start-up and maintenance performance metrics and provide timely updates, risk identification, and escalation of potential delays to project teams and management as appropriate.
Qualifications
- Experience in Clinical Research, including Regulatory Start-Up, CRA, Study Coordinator, or Site Management roles is preferred.
- Experience with IRB submissions (initial and maintenance) and site budget/contract negotiations (initial and amendments)
- Ability to communicate effectively in English, including participation in teleconferences and preparation of written communications with global teams and sponsors.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
