ProClinical is currently seeking a Clinical Trial Coordinator for a leading provider of global talent management solutions. This position supports all clinical studies from study start-up through close-out. The Clinical Trial Coordinator (CTC) is responsible for supporting the Clinical Research Manager (CRM) and Clinical Research Associate (CRA), to ensure clinical study documentation (trial master file) is complete, accurate and on file according to standard operating procedure, as well as assist with clinical trial progress tracking and reporting as required. This is a permanent role based in Jacksonville, Florida.
- Responsible to review protocols, informed consent forms, and case report forms to ensure consistency and accuracy in conjunction with the CRA
- Responsible for forecasting and calculating study specific supply needs
- Support user acceptance testing, review Electronic Data Capture reports and data listings, and discuss findings with CRA
- Coordinate and plan investigator meetings, site training, and other company functions
- Monitor Electronic Data Capture for assigned Study
- Co-monitor internal or external Clinical Study Site
- Responsible for the set-up of the Trial Master File, investigator study file binders and regulatory document collection
- Support clinical supply unit to assure investigational material supply documentation to sites is clear, accurate and filed appropriately
- Assist with all aspects of test article accountability and reconciliation including shipping and reconciliation document reviews
- Enter and maintain required documentation in study specific databases related to purchases, contracts, health care compliance, study document management, and other areas as required
- Other duties as assigned
- Obtain CR (Protocol) number
- Create Trial Master File
- Generate site regulatory binders
- Perform debarment checks
- Review, track, scan and upload regulatory documents to eTMF, and file in TMF
- Schedule and set up Site Initiation Training meetings
- Work with on-site printing vendor as required to generate study documents (e.g., ICFs, assents, questionnaires, instructions)
- Draft Research Agreements for approval
- Field all study-related questions and document in communication file in TMF
- Regular TMF review
- Schedule meetings, generate and publish meeting minutes
Skills and Requirements:
- Bachelor's degree or higher from an accredited institution and 0-3 years' related experience
- Strong organizational skills
- Microsoft Office products - Word, Excel, PowerPoint, Project, and SharePoint
- Ability to work with minimal supervision in a Team environment
- The ability to understand written work instructions and follow the requirements
- Highly developed communication skills to include all levels of an organization
- 1 year's leadership experience preferred
- Knowledge of FDA guidelines, regulations and/or Good Clinical Practice a strong plus
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Christopher Frank on +1 267 405 6996 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.