Clinical Records Associate II
Morris Plains, NJ
Hybrid, 2 days onsite per week
General Position Summary / Purpose:
· The Clinical Records Associate II in the Clinical Records Team will support 2 key activities
· Mergers, Acquisitions, Divestitures & Out-licensing
· Clinical contract processing, management, and archiving.
· As a member of the Clinical Records team, the Associate will collaborate cross functionally across, Clinical Operations and Development Business Operations functional groups in the planning, development, and implementation of standards, processes, and projects for the TMF (Trial Master File) and Clinical Agreements/contracts.
· The successful candidate will be responsible for ensuring effective and efficient archiving of the TMF, clinical agreements and associated records as well as complying with relevant regulatory, legal, country specific and corporate requirements to produce and maintain inspection readiness for clinical records.
Key Accountabilities / Core Job Responsibilities
· Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of the Trial Master File and clinical agreements.
· Perform project intake activities including creating records of incoming documents filing of incoming documents, and retrieving copies of paper protocol agreements from TMF room for Apttus filing
· Collaborate with management to generate central intake report on a daily and published in a timely fashion
· Responsible for the continued maintenance of eTMF, (GDAR) and Apttus contract filing.
· Ensure record filing is kept up to date is performed accurately
· Work with management to develop and maintain quality assurance and control plans
· Lead assigned meetings and projects.
· Develop and maintain department process guidance, training materials, policies and procedures, and other quality documents
· Manage off-site storage of records and ensure proper process is in place for off-site archival of paper agreements.
· Respond to internal and/or external information inquiries related to contract filing and records retention of those agreements; supports internal and external audits and inspections
· Process inquiries, review of incoming agreement, and filings sent to the DMT mailbox.
Qualifications / Requirements
· 3-5 plus years of relevant experience
· BA/BS required
· Expert in Microsoft programs including, but not limited to, MSWord, PowerPoint, Visio, Access, Project and Excel
· 3 plus years of project management experience with PMP preferred
· 5 plus years of Clinical Research Associate (CRA) or relevant records management/ TMF management experience equivalent experience preferred
· Exemplary interpersonal skills with proven demonstration
· Knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and GCP guidelines related to Clinical Document Management