Clinical Study Coordinator

General Summary

Provides administrative support for clinical trial management by organizing and coordinating clinical studies and local teams for clinical research trials, monitors study timelines, and manages clinic floor regarding equipment set up and scheduling meetings.

Primary Responsibilities

• Participates in the assessment, preparation and implementation of studies for the clinic to ensure timely and high-quality study output.

• Provides support in reviewing and assessing protocol, clinic budget, case report forms, informed consent forms and volunteer information.

• Coordinates availability of study materials and equipment, creation of corresponding instructions, validation and verification of testing new equipment and approval of invoices.

• Communicates any changes in scope or cost to management and escalates issues and/or major deviations as needed.

• Prepares and maintains clinical documents. Monitors submission of documents to the Institutional Review Board (IRB).

Level-Specific

Responsibilities

• Supports the organization and preparation of clinic specific meetings, site invitation visits and monitoring visits in cooperation with the data entry staff.

• Assists in the closing of the clinical conduct of the study by coordinating restitution and/or storage of study materials, equipment and documents and study evaluation.

• Assists with managing the clinic floor by answering questions, helping with setup, modifying schedules, etc.

• Assists with the planning and coordinating of outpatient visits.

• Tracks study specific training.

Knowledge, Skills and Abilities

• Good knowledge of ICH/GCP guidelines

• Good knowledge of internal and external regulations, standard operating procedures and work instructions

• Good knowledge of pharmacokinetics and pharmacodynamics

• Good written and oral communication skills

• Good ability to conduct authorized medical procedures and measurements such as sampling, CPR, Immediate Life Support, etc.

Physical Requirements

Work is typically performed in an clinic environment, using simple, easy muscular movements, involving only the handling of light materials, tools, or equipment and may require long periods of standing and walking.

Typical Minimum Education*

Associate’s degree or international equivalent