JOB DESCRIPTION

Description :

Perform site contract negotiation, site start up activities & site evaluation including, collection and review and close out of required critical documents from sites (including submissions and notifications to Institutional Review Boards or Ethics Committees (where applicable) by creating, updating, tracking, and maintaining study-specific trial management files, tools, and systems.

Responsibilities :

• Independently administers and negotiates site contracts and amended documents that support projects within Clinical Operations in accordance with sponsor and Company requirements.
• Support contract management tasks with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
• Serves as communication liaison between site contracts staff, internal and external customers.
• Successful negotiation processes for complex site contracts that support projects within Clinical Operations.
• Primary contact and liaison with investigative sites during study maintenance and when assigned, site start-up (SSU) activities, with responsibility for collection of the required investigator and regulatory documents to ensure EC applications are made within the timelines agreed with project management and SU team.
• Perform site evaluation including, collection and review and close out of required critical documents from sites (including submissions and notifications to Institutional Review Boards or Ethics Committees (where applicable)) by creating, updating, tracking, and maintaining study-specific trial management files, tools, and systems.
• Effectively communicate with sites, colleagues and study team management via email, phone, and web meetings.
• Collect and track regulatory & investigator documents required for effective and compliant study start up, site activation and maintenance.
• Draft a variety of reports, documents and correspondence for regulatory agencies, participating clinical trial sites and for internal purposes to assist in the ongoing monitoring and evaluation of the clinical trial's progress.
• Follow up with sites in order to ensure documents required are collected in a timely manner.
• Update study documents when there are changes in study personnel / study amendments.
• Contribute to the preparation of submissions to IRB / IEC with appropriate supervision.
• Ensure high quality site documents are filed in the TMF in a timely manner according to study plans.
• Manage milestone and drivers in client CTMS.

Experience Level : Intermediate Level

Intermediate Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market.

With a network of almost 30, consultants and more than 4, clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune .

Diversity, Equity & Inclusion

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options.

Last updated : 2024-02-23