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Clinical Operations Coordinator II

hace 2 meses

Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo

Overview:
As a vital member of the Project Team, the Clinical Trial Coordinator II plays a crucial role in providing both administrative and technical assistance. This position is essential for maintaining audit readiness by ensuring that files are systematically reviewed in accordance with the organization's Standard Operating Procedures (SOP) and departmental guidelines. The coordinator also supports site activation processes, contributing to the development of the critical path for rapid site activations within assigned projects.

Key Responsibilities:
● Collaborates with the global medical research community, representing the organization effectively.
● Establishes and nurtures collaborative relationships with investigators and site personnel to conduct thorough feasibility assessments, adhering to established timelines.
● Develops a comprehensive local knowledge base of sites in the relevant market by working closely with local company personnel.
● Utilizes local insights, organizational systems, external site lists, and sponsor directives to curate and evaluate site lists that align with the strategic needs of feasibility activities.
● May assist in the onboarding process by acting as a buddy and supporting the training of new staff members.
● Engages in departmental initiatives aimed at enhancing processes and improving overall efficiency.

Qualifications:
High School diploma or equivalent is required, with relevant formal academic or vocational qualifications. A Bachelor's degree is preferred. Candidates should possess prior experience that equips them with the necessary knowledge, skills, and abilities to excel in this role, typically comparable to at least two years of experience.

Essential Functions:
● Depending on the specific role (Central or Local), coordinates, oversees, and executes functions related to assigned trial activities as outlined in the task matrix.
● Conducts reviews of departmental, internal, country, and investigator files as assigned, documenting findings in the appropriate systems.
● Ensures that allocated tasks are completed punctually, within budget, and to a high standard of quality.
● Proactively communicates any potential risks to project leads and line management as necessary.
● Performs administrative duties for assigned trials, including timely processing of documents, conducting (e)TMF reviews, and managing communications.
● Reviews and monitors local regulatory documents and analyzes study metrics and findings reports.
● Assists in clarifying and resolving any discrepancies related to site documentation.
● Maintains vendor trackers to ensure effective oversight.