Senior Clinical Trials Associate

Requisition Number: 894

Position Title: Senior Clinical Trials Associate

External Description:

Worldwide Clinical Trials is hiring a Clinical Trials Associate to join our growing team! The role can be based in King of Prussia, PA or Morrisville, NC.

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.

RESPONSIBILITIES:
Tasks may include but are not limited to:

• 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 

REQUIREMENTS:

• Four year college curriculum or university degree
• At least 1.5 years experience in similar role/position
• Skill sets and proven performance equivalent to above 

#LI-HD1

City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Senior Clinical Trials Associate

Company Profile:

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: Research Triangle Park (RTP), North Carolina US

CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.