Site Activation Specialist

The Site Activation Specialist is responsible for site start-up activities for the assigned studies within the Site Alliance and Site Activation Sub-Chapter under Clinical Operations. The position will require strong stakeholder management working closely with Contracting, Legal, Privacy, Study Teams, CRO, and Sites.

Responsibilities: 

● Responsible for the effective operations and delivery of site activation deliverables across all regions, within the assigned projects.

● Supports the pre-study site identification/selection process for relevant studies through collection and analysis of site feasibility information.

● Maintain regular communications with investigational sites/CRO to ensure timely completion of the required site activation activities/documentation and resolve or escalate issues in a timely manner

● Collect, receive and perform the first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines, and study timelines and requirements

● Coordinate Investigator Review Board (IRB)/Ethics Committee (EC)/other relevant regulatory submissions in collaboration with sites/study teams

● Work with sites to ensure informed consent form meets the required regulatory and company requirements.

● Facilitate the translation of essential documents that may be required in languages other than English for the purposes of submission to and approval from Competent Authorities and/or IRB/EC.

● Coordinate the clinical trial insurance process to ensure timely results and support throughout the conduct of the clinical study.

● Support contract and budget negotiations in partnership with Contracting and Study Teams.

● Ensure Purchase orders and Fair Market Value assessments are completed for timely start-start up.

● Support study instrument placements, Obtain import/export licensure

● Support implementation and use of eTools at the site

● Collect and maintain relevant country, local, state, and site-level regulatory intelligence for future use

● Work closely with Study Teams to deliver study start-up tasks.

● Solve identified issues with appropriate timely escalation to the Study Teams

● Support internal audit and external inspection activities; contribute to CAPAs as required.

● May be responsible for other responsibilities as assigned.

Qualifications: 

● Associate or Bachelor’s degree in chemistry, biology, other life sciences, or a related field, or equivalent combination of education and experience
● Experience in study start-up is required
● Experience with CRO management is a plus.
● Experience in clinical trial planning, including IRB/Ethics Committee, Competent authority submissions and contracts
● Knowledge of clinical trial methodologies, medical terminology, ICH/GCP
● Must be fluent in English, and the language of the appointed location
● Working knowledge of global and local regulatory requirements (IVDR and other applicable regulations) is a plus.
● Understand the quality expectations and emphasis on the right first time, attention to detail
● Ability to organize tasks, time, and priorities, ability to multi-task
● Required to support multi-national team members, and flexibility in working hours may be needed.
● Participate and work effectively with multiple cross-functional teams