Clinical Trial Coordinator II

Employment Details

Employment Type: Full time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office

Job Description

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 mentorship 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 result timelines. May develop a local knowledge base of sites in the respective market through collaboratively working with local company personnel. May apply 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.

Qualifications

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 4 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 high-quality 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 supervises local regulatory documents.