Senior Clinical Trials Associate
Location: Morrisville, North Carolina, United States
Requisition Number: 1063
Position Title: Senior Clinical Trials Associate
SUMMARY: The Clinical Trials Associate is a full time position responsible for ensuring all assigned projects for Clinical Operations are performed timely and accurately while interfacing directly with in-house personnel and field employees. The Clinical Trials Associate develops required tools, forms and documents, and provides additional administrative support for Clinical Operations.
- Develop and maintain documents, tools, forms and related items in MS Word, Excel, Access and Publisher, including reformatting and troubleshooting issues with existing documents and macros
- Assist Clinical Operations personnel with study initiations and special projects
- Provide technical assistance to project team (Project Managers, Lead CRAs, CRAs, etc.) with forms, letters, reports, manuals and other documents
- Manage document control functions, including maintaining Master List of paper and electronic documents and media generated and distributed
- Audit and resolve issues of redundancy, currency and consistency of documents on shared drive and portals
- Maintain and quality audit to assure most recent revisions of documents are on portals and server
- Assist project team (CRAs, Lead CRAs and Project Managers, etc.) with collation of documentation required for submission to Regulatory Authorities and Ethics Committees administrative support to the preparation of contracts
- Assist with maintenance of trial master file documents as appropriate and needed
- In liaison with the CRAs, manage preparation of documents for grant payments
- Regularly review the status of key documentation in the file for SOP compliance
- Provide support to Clinical Operations Manager on an ad hoc basis.
OTHER SKILLS AND ABILITIES:
- Excellent written and verbal communication skills
- Ability to work independently and as a team member
- Strong interpersonal skills in a fast-paced and rapidly changing environment
- Ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval
- Ability to handle multiple tasks, including rapid response in generating new documents, forms and tools
- Strong organizational skills, including ability to develop naming conventions and filing architecture
- Advanced skills in MS Office applications including Microsoft Word, Access, Excel, PowerPoint and Publisher.
- Knowledge and understanding of ICH, GCP and FDA or EU directive regulations (as applicable) as well as local regulatory requirements
- Excellent spoken and written English skills as well as fluency of the language of the country of location
- Four-year college curriculum or university degree, life science preferable
• At least one years’ experience in office administration or similar position
• Skill sets and proven performance equivalent to above
State: North Carolina
Employment Type: Regular
Community / Marketing Title: Senior Clinical Trials Associate
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Morrisville, North Carolina US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.