DATA AND RECORDS TRANSCRIPTION COORDINATOR
Duties: The Data and Records Transcription Coordinator will support the transcription and verification of data from cell and gene therapy clinical trials supported by the Clinical Cell and Vaccine Production Facility (CVPF) at the University of Pennsylvania. This position will reside within the CVPF Scientific Affairs functional group and will work closely with other functional groups of the CVPF, as well as academic and industry collaborators.
Responsibilities will include but are not limited to:
* Become proficient in the use of all applicable databases used by the CVPF to perform data entry of clinical manufacture data, or as applicable. Coordinate the source data verification (SDV's) and/or data entry, as needed.
* Ensure CRF fields in the database are in alignment with CVPF manufacturing records.
* Initiate database updates when necessary.
* Participation in and compilation of related study information in support of study monitoring visits, internal investigations, or ad-hoc requests, when applicable.
* Verification that all required by study procedures are completed and transcription of data points from the source documents (e.g., MFG reports) into the Case Report Forms (CRFs) is done accurately and without errors.
* Responsible for performing data entry into the appropriate database(s) (e.g. PPD, Oracle, etc), ensuring it is performed in an accurate manner and without errors.
* Assume a lead role for a study which may include study specific data entry training and identification of resource needs.
* Update and maintain study related patient lists and calendars, as needed.
* Respond to data queries and obtain signatures from study staff as needed.
Qualifications: The minimum of a High School diploma and 5 years of experience, or an equivalent combination of education and experience, required. College degree or coursework preferred.
1. Previous working experience in a GMP environment is required.
2. Demonstrated experience of working collaboratively in a team environment is required.
3. Demonstrated experience meeting critical deadlines; maintaining precision and accuracy, and performing under pressure are required.
4. Demonstrated proficiency utilizing computer software is required.
5. This position mandates the highest degree of attention to detail
Reference Number: 40-27792
Salary Grade: 025
Employment Type: Non-Exempt
Org: PA-Pathology Bioresource
Job Family: 6-Technical Scientific/Statistical