Senior Clinical Document Associate - Study Start-Up CONTRACTOR

Job Description

SUMMARY/POSITION OBJECTIVE

The Temp – Sr. Clinical Documentation Associate - Study Start-up (CDA-SSU), will serve as the primary contact for the requirements, coordination and review of essential documents required for release of Investigational Product on site for the conduct of a clinical trial. This role will also ensure the clinical study documents associated with study start up are filed in the electronic Trial Master File (TMF) in compliance with SOPs. The Temp Sr. CDA SSU will also serve as the primary contact for adding investigators and organizations to the Regeneron Global Directory. They will work with Global Trial Optimization, the Clinical Study Lead, the CRO and the Site to ensure that study sites and investigators are set up for Regeneron clinical studies.

Job duties

• Review and assess study documents required for site activation and investigational product release according to relevant SOPs and regulations, provide feedback to provider as necessary.
• Maintain metrics on results of study documentation reviews and provide to management periodically.
• Ensure all relevant documents are uploaded into the Electronic Trial Master File (eTMF)
• Provide applicable essential documents to regulatory for submission to the FDA
• For inhouse studies (typically phase 1), prepare and distribute regulatory documentation packages for site completion.
• Filing/uploading of essential clinical documents and maintenance of the TMF as applicable
• Prepare and maintain transmittals and trackers of essential documents as applicable
• Handle the exchange of TMF documents with external service providers as applicable
• May maintain file QC schedule for assigned studies and performs periodic quality checks and inventories of study/project TMFs to ensure completeness and inspection ready
• Successfully communicate and drive study document management compliance and quality issues to line manager and offer potential solutions.
• Gathers relevant information to build investigator/institution entities within the CTMS system to then enable site association with a clinical trial; routinely reconciles outstanding identifiers to ensure adherence to Sponsor requirements in addition to the alignment of industry/CRO related Identifiers.
• Gathers, tracks and reports on the status of Site Creation and Site Selection to ensure that all required study identifiers have been assigned and communicated as needed to promote alignment across standalone systems and repositories.
• May supervise Site Training Documentation to ensure that Investigator site staff are appropriately trained on GCP/ICH guidelines, patient data capture requirements, Safety Letter distribution and other protocol specific requirements that may be defined by the clinical study team.

Job requirements

• Ability to travel approximately 10-15% in support of inspections or audits
• Proficient in oral and written communication, excellent organizational skills and the ability to run multiple tasks with great attention to detail
• Good interpersonal skills with an ability to work in a team environment and independently
• Must be flexible and able to handle a fast paced environment
• Familiarity with clinical trial processes and ICH/GCP guidance and working knowledge of essential documents
• Ability to think critically and problem solve
• Knowledge of eTMF and CTMS systems
• Understanding of the TMF reference model or similar filing structure
• Proficient in Microsoft Office software applications

Minimal educational requirements:

Bachelor's degree and 1-3 years in essential or regulatory document management in Pharmaceutical /CRO industry, understanding of clinical study start up requirements and working knowledge of relevant documentation.