Clinical Operations Assistant

Requisition Number: 716

Position Title: Clinical Operations Assistant II

External Description:

SUMMARY: The Clinical Operations Assistant is a full-time position responsible for completing all assigned projects for Clinical Operations in a timely and accurate manner while interfacing directly with in-house personnel and field employees. Key functions include management of essential document submission to Trial Master Files, supporting field personnel with Microsoft Office, and providing additional administrative support when time permits.

RESPONSIBILITIES:

• Manage and track document flow of essential documents from investigator sites to the Trial Master Files
• Collect, review, organize and perform quality review of information for database entry ensuring the suitability of submissions
• Function as TMF Submitter for assigned trials and manage TMF submission process for site-level documents.
• Manage, track and ensure proper re-submission of rejected TMF documents for site level
• Track, identify and escalate trends in omissions of submitted documents from sites and/or Clinical Research Associates
• Develop and maintain documents, tools, forms and related items in MS Word, Excel, Access, PowerPoint and Publisher, including reformatting and troubleshooting issues with existing documents

Assist Clinical Operations personnel with completion of study-specific tasks (e.g. study initiation, and preparation of study file notebooks)

• Maintain interdepartmental communication to ensure consistency and availability of new forms and revisions
• Audit and resolve issues of redundancy and consistency of Clinical Operations documents on the shared drive, SharePoint and portals
• Provide administrative support to the Clinical Operations department
• Develop and distribute periodic communication materials

OTHER SKILLS AND ABILITIES:

• Excellent organizational skills, time management, written and oral communications
• Strong interpersonal skills in a fast-paced and rapidly changing environment
• A broad range of knowledge and advanced skills in the use of computer software including, but not limited to, word-processing, spreadsheets, electronic communications, and graphics
• Ability to prepare presentations in a clear, focused, and concise manner
• Ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval
• General knowledge of clinical research principles
• Knowledge of standard operating procedures

 

REQUIREMENTS:

• Science-related Bachelor’s Degree and 1 or more years’ experience in clinical research required.

#LI-HD1

City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Clinical Operations Assistant

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.