Job Category: Clinical Affairs
Job Number: 11800760
Akraya is looking for a Clinical Contracts Associate for one of our clients. If the job description below is a fit, please apply directly or call Ashu Pandey at 408-816-2228. If this position is not quite what you’ re looking for, visit akraya.Com and submit a copy of your resume. Our recruiters will get to work finding you a job that is a better match at one of our many clients.
Primary Skills: Clinical, Clinical research, Clinical trial, ICH, FDA and or EMEA Regulations, GCPs, clinical administrative, TMF, GDAR, eTMF, electronic records.
Duration: 06 Months (Possibility for Extension)
Contract Type: W2 Only
- Responsible for clinical administrative operations activities involving clinical contract and budget support including but not limited to filing, scanning, mailing, populating spreadsheets and other administrative tasks as assigned.
- Provide contract administration support in response to Contracts Records Management and Cleanup for GDAR, Apollo migration and Apttus CLMS.
- Contracts Coordinator will be responsible for performing the following:
- Reconcile contracts in Apollo and Apttus CLM
- Review all executed clinical contracts saved on Apollo and Apttus CLM and perform reconciliation between the contracts that are saved in these two platforms
- Scan and create Optical Character Recognition (OCR) via Adobe Acrobat for various executed contracts including CTAs, CDAs, LOAs, Vendor Agreements
- Performing QC on the scanned contracts to ensure: All pages of the documents are included, All required signatures are verified and present, All budget pages are legible, All pages have undergone OCR conversion, Documents have been saved in the Shared Folder in Apollo, Enter Agreement Party Information on Apttus CLM
- Identify metadata for each contract and Upload contract(s) to Apttus
- Complete required metadata fields in Apttus with contract party information
- Create and maintain study specific file structures for Client TMF documentation and file documents accordingly.
- Create file folders/labels according to TMF plan, file incoming documents, retrieve documents, schedule document review.
- Ensure record filing is kept up to date and is performed accurately.
- Offsite archival of documents; ensure appropriate documentation completed to track archival.
- Conversion of paper documents to electronic records.
- Participate in continued security and maintenance of the Trial Master File (TMF) Room.
- Completes responsibilities in a timely, organized way.
- Identifies issues/problems and provides customary recommendations for solutions
Please apply directly with your update resume or call Ashu Pandey & 408-816-2228
- 2 years of experience with a BA or BS in a relevant discipline.
- Demonstrates excellent verbal, written, and interpersonal communication skills.
- Performs routine work without detailed instructions.
- Interacts well with teams.
- Supports senior peers on non-complex projects to learn through experience.
- Must be familiar with Word, PowerPoint, and Excel. Knowledge of FDA and or EMEA Regulations, ICH Guidelines, GCPs, and/or familiarity with standard clinical operating procedures is a plus.
- Must be able to work both independently and as part of a team.
Akraya, Inc. Is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “ Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.Com to search through all of our current openings or to submit your resume to our recruiting team.