Clinical Research Coordinator II

hace 2 semanas

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

Overview:
As a Clinical Trial Coordinator II, you will provide essential administrative and technical assistance to the Project Team. Your role will be pivotal in maintaining audit readiness by ensuring that files are reviewed in accordance with the established schedule outlined in the organization's Standard Operating Procedures (SOP) and departmental guidance documents. You will also support site activation efforts and contribute to the development of the critical path for site activation within assigned projects, facilitating efficient site activations.

Key Responsibilities:
● Represent the organization within the global medical research community.
● Foster collaborative relationships with investigators and site personnel to conduct feasibility assessments in line with established processes and timelines.
● Build a local knowledge base of sites within the respective market by working closely with local company personnel.
● Utilize 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, while also providing local input into the site tiering process.
● Act as a mentor during the onboarding phase for new team members.
● Participate in training initiatives for new staff and engage in departmental projects aimed at process enhancements.

Qualifications:
High school diploma or equivalent, along with relevant formal academic or vocational qualifications. A Bachelor's degree is preferred. Previous experience that equips you with the necessary knowledge, skills, and abilities to excel in this role (equivalent to at least 2 years) is essential.

Essential Functions:
● Depending on the specific role (Central or Local), coordinate, oversee, and execute functions related to assigned trial activities as specified in the task matrix.
● Conduct department, internal, country, and investigator file reviews as assigned, documenting findings in the appropriate systems.
  • Ensure that assigned tasks are completed on time, within budget, and to a high-quality standard.
Proactively communicate any potential risks to project leads and line management as necessary.
● Perform administrative duties related to assigned trials, including but not limited to the timely processing of documents sent to the Client (eTMF), conducting eTMF reviews, distributing mass communications, and providing necessary documents and reports to internal team members.
  • Review and track local regulatory documents.
  • Analyze and reconcile study metrics and findings reports.
Assist in clarifying and resolving issues related to site documentation.
  • Maintain vendor trackers.

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