Clinical Trial Coordinator II

at  Thermo Fisher Scientific

JOB DESCRIPTION

Summarized Purpose:
Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring
files are reviewed according to the schedule detailed in the organization’s SOP and department guidance
document. Provides administrative support for site activation activities. Aids the development of the
critical path for site activation within assigned projects in support of rapid site activations. Represents the
organization in the global medical research community. May develop collaborative relationships with
investigators and site personnel to conduct feasibility assessments in accordance with feasibility
processes and within deliverable timelines. May develop a local knowledge base of sites in the respective
market through collaboratively working with local company personnel. May utilize local knowledge,
organization systems, external site lists and sponsor directives to develop and review site lists that are
suitable for the strategic needs of feasibility activities and to provide local input into the site tiering
process. May act as a buddy during onboarding phase. Supports training of new staff and participates in
departmental initiatives to aid in process improvements/enhancements.Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
Bachelor’s degree preferred.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at
least 2 years).
Essential functions:
 According to the specific role (Central or Local), coordinates, oversees and
completes functions on assigned trial(s) activities as detailed on the task matrix.
 Performs department, Internal, Country and Investigator file reviews as assigned
and documents findings in appropriate system(s).
 Ensures allocated tasks are performed on time, within budget and to a highquality standard. Proactively communicates any risks to project leads and line
manager as appropriate.
 Performs administrative tasks on assigned trials including but not limited to
timely processing of documents sent to Client (e)TMF as assigned, performing
(e)TMF reviews, distributing mass mailings and communications as needed,
providing documents and reports to internal team members.
 Reviews and tracks local regulatory documents.
 Analyzes and reconciles study metrics and findings reports. Assists with
clarification and resolution of findings related to site documentation.
 Maintains vendor trackers

Please refer the Job description for details