Clinical Document Associate - CDMG

Recruiter
Aerotek, Inc.
Location
Tarrytown
Salary
Competitive
Posted
Aug 13, 2017
Closes
Sep 09, 2017
Industry
Service
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
Reason for opening: Department Growth

Summary: The Clinical Document Management Associate l, is responsible for the management of the clinical study documents in the Trial Master File (TMF) from the development of the filing structure (study start-up) through final archival of study documents in compliance with applicable SOPs and guidance.

Responsibilities:

* Manage access and organization of the controlled clinical document storage on-site, including ensuring the defined file structure is maintained for assigned studies

* Scan (or coordinate scanning as applicable), properly name, and upload documents into the eTMF

* Filing of essential clinical documents and maintenance of the TMF as applicable

* Prepare and maintain transmittal's and trackers of essential documents as applicable

* Prepares and transitions study documents to long-term archiving facility as applicable and maintain study archival records

* Retrieves study documents from long term facilities when requested

* Work with Clinical Trial Managers, Clinical Trial Associates, and Clinical Trial Operations Associates to provide updates of the study file status

* Manage the exchange of TMF documents with external service providers as applicable

* Maintain file QC schedule for assigned studies and performs periodic quality checks and inventories of study/project TMFs to ensure completeness

* Effectively communicate and drive document management compliance and quality issues to the clinical study teams and management, and offer potential solutions.

* Support the clinical study teams in ensuring regulatory documents are submission and audit ready

* Perform vendor TMF review and site visits, as applicable.

* Liaise with functional team members to evaluate study-specific filing needs and aid in the development of study-specific procedures for managing and maintaining the TMF as applicable

* Provide status updates and information to management on a regular basis.

About Aerotek:

Our people are everything. As a Best of Staffing?? Client and Talent leader, Aerotek?? Inc. has distinguished itself as a leader in recruiting and staffing services, by having a deep understanding of the intersection of talent and business. As a strategic partner to more than 17,000 clients and 300,000 contract employees every year, Aerotek's people-focused approach yields competitive advantages for its clients and rewarding careers for its contract employees. Headquartered in Hanover, Md., Aerotek operates a network of over 230 non-franchised offices with more than 6,000 internal employees dedicated to serving our customers. Aerotek is an operating company of Allegis Group, a global talent solutions provider. To learn more, visit aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call or email for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Contact Information

Name:

Lauren Houmis

Email:



Phone:

Posted by StartWire