Clinical Trial Coordinator (Level I)

Work Schedule

Environmental Conditions

Job 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.

What Youll Do:
Coordinates oversees and completes functions on assigned trials activities detailed on the task matrix.
Performs department Internal Country and Investigator file reviews as assigned and documents findings in appropriate system.
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.
Supports the maintenance of study specific documentation and global support with specific systems tools and trackers including but not limited to: study team lists tracking of project specific training requirements system access management for organization/vendor/clients and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system.
Provides system support (i.e. Activate CTMS & eTMF).
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 performing mass mailings and communications as needed providing documents and reports to internal team members.
Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
Maintains vendor trackers.
Assists with coordination compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.

Education and Experience Requirements:
Bachelors/ Masters degree in Life Sciences/ Pharmacy
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 1-2 years).

Knowledge Skills and Abilities:
Ability to work in a team or independently as required
Strong organizational skills and attention to detail with proven ability to handle multiple tasks efficiently and effectively
Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
Strong customer focus
Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations ICH Good Clinical Practices and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation execution and closeout
Excellent English language and grammar skills and proficient local language skills as needed
Good presentation skills
Excellent computer skills proficient in MS Office (Word Excel and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
Ability to successfully complete PPD clinical training program
Self-motivated positive attitude with effective strong interpersonal skills

Working Conditions and Environment:
Work is performed in an office/ home office environment with exposure to electrical office equipment.