Clinical Trial Coordinator
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Job Location:
Monthly Salary:
Posted on:
3 days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Clinical Trial Coordinator Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.
As part of our global team youll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Trial Coord youll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organizations SOP and department guidance document. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations. Representing CRG personnel you 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. Additionally you may act as a buddy during the onboarding phase and provide training to new staff as needed.
What Youll Do:
Coordinates and executes assigned clinical trial activities in line with the task matrix ensuring tasks are completed on time within budget and to a high-quality standard while proactively communicating risks.
Performs country site and investigator file reviews documenting findings and supporting resolution of site documentation issues.
Provides system support (CTMS Activate eTMF) and ensures data accuracy and maintenance.
Manages administrative trial tasks including document processing TMF reviews communications and reporting.
Supports regulatory submissions start-up activities and site activation processes working directly with sites to collect and manage required documentation.
Assists with preparation and distribution of Investigator Site Files pharmacy binders and study materials as well as translation coordination and quality control.
Maintains trackers study documentation training records and system access while ensuring compliance with SOPs client requirements and regulatory guidelines.
Supports site feasibility selection and engagement activities including survey review site communication and follow-up tracking.
Collaborates cross-functionally to meet project timelines escalates risks and contributes local insights on site capacity and performance.
May also support RBM activities meeting coordination vendor tracking and onboarding/training of new team members.
Education and Experience Requirements:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
Bachelors degree preferably in Life sciences (Pharmacy Medicine Biology etc.)
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 0 to 1 year).
In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
Knowledge Skills and Abilities:
Ability to work in a team or independently as required
Good organizational skills and strong attention to detail with proven ability to handle multiple tasks efficiently and effectively
Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
Strong customer focus
Flexibility to reprioritize workload to meet changing project timelines
Good English language and grammar skills along with proficient local language skills as needed
Good computer skills including proficiency in MS Office (Word Excel PowerPoint) and ability to learn clinical trial systems
Effective oral and written communication skills
Strong interpersonal skills
Sound judgment and decision-making skills
Ability to accurately follow project work instructions
Good negotiation skills
Independent thinker
Ability to manage risk and escalate appropriately
Working Conditions and Environment:
Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment.
Occasional drives to site locations. Potential Occasional travel required.
Required Experience:
IC
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
