Clinical Trial Assistant SGS North America, Inc., Germantown, MD.
Responsibilities: - Updates and maintains tracking logs and CTMS system
- Tracking of ICH/GCP and/or FDA 21 CFR essential study documents using the applicable tracking tools
- Records and compiles minutes from team meetings
- Stores and ships ancillary supplies to sites
- Assist project managers and CRA's with developing/printing TMF binders
- Assist project managers, LCRA's and CRA's with mailings to sites, faxes, regulatory documents
- Assists as directed in file audits
- Completes IRB submission
- Review submission package for completion and accuracy before submission to the IRB, ensures that the submission is done and that any issues resulting from these submissions are followed-up in a timely way
- Submitting Safety Updates (SUSAR's and SAE's) to the investigators and the Central IRB
- Collaborates with internal project team members to assure timely site initiation process
- Reviews Clinical Trial Management System (CTMS) information to ensure documents are current and update as needed
- Inform CRA regarding expiring documents
- Scan and upload documents to the eTMF system if applicable, ensure documents are of good quality prior to upload
- Assist in the planning and execution of Investigator Meetings
- Reviews regulatory documents for completeness and accuracy
- Preparing the archiving of the study documents and/or return of the documents to the sponsor of the trial, per the agreement with the sponsor and the applicable SOP
- Writing letters, faxes, emails and telephone reports; reviews, uploads and updates eTMF system as needed
- Responsible for training any US based employees (SGS or external) on the eTMF
- Responsible for the setup of clinical trial binders in electronic system, responsible for activating/deactivating users in the system, US based contact for questions or issues; and contract Negotiations with Investigators and Clinical Sites
Qualifications: - Must have a High School Diploma plus two (2) years of experience in the job offered or related occupation.
- Must have 2 years exp. working for a Contract Research Organization
- 2 years exp. utilizing TMF
- 2 yrs. exp. with Contracts working with Investigative Sites.
Please apply online at Job Req. No. 036112.
