Description: CBSET, Inc. is a recognized leader in preclinical biomedical research. We make it our mission to help our sponsors accelerate the development of novel and innovative pharmaceuticals, biotechnologies, and medical devices. CBSET offers extensive regulatory and scientific expertise to the medtech and biopharma industry around the globe in order to rapidly transform early-stage concepts into novel therapies.
BASIC SUMMARY: Assist in the coordination, organization, and prioritize study tables as well as assist in the review of in-life data. This is an entry level position with the expectations of supervised and/or semi-independent functionality, demonstrating a comfortable level of project coordinating and writing skills in the Medical Writers Department.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Assists in the quality control (QC) of in-life data in accordance with SOP, GLPs, and protocol standards. Also assists to ensure that the appropriate person(s) receive and make corrections to data before returning to Study Director and/or QA. Assists in meeting data submittal timelines through the coordination of data review.
- Participates in the general data overview during procedures as appropriate (i.e., assisting in the in-life QC process of study records on a daily basis for compliance with SOPs and/or protocols)
- Assist in the assembly of in-life tables for reporting purposes as well as the final preparation of the study binder.
- Assist in the administrative tasks (scanning items for Study Directors, and/or Medical Writers)
- Assist/coordinates Sponsor requests to aid Study Directors
- Assists in interdepartmental collaboration; ensure effective communication, process improvement, and data flow/transitions.
- Sorts/distributes the CBSET and outside vendor paperwork
- Assists in the coordination and responds to in-life QAIRs to ensure that the QAIRs are addressed in a timely manner.
- Assists in updating data timelines on portal/Excel spreadsheet.
- Assists in the transfer of study books to DSU (Data Storage Unit) when initial QC is complete and track data update data schedule.
- Performs other duties as assigned.
QUALIFICATIONS: The ability to multi-task, coordinates, prioritize, and implement change in combination with flexibility as well as excellent communication and writing skills is a must.
- Experience with Microsoft Office, Word Processing spreadsheets (Excel, etc.), and Adobe software.
- Industry related pre-clinical data management skills experience preferred.
- Undergraduate degree in a related life sciences field preferred.
- Experience with Electronic Data Management System software in a lab setting preferred.
- Must be computer literate with a willingness to learn and adapt to various computer skills.
- Must pay attention to detail and constantly question the validity of data.
PHYSICAL DEMANDS: Must be able to lift heavy books and sit and type for long periods of time.
WORK ENVIRONMENT:
General office working conditions, with generally quiet noise conditions.
Job Types: Full-time, Part-time
Pay: $24.03 - $28.03 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Tuition reimbursement
- Vision insurance
Work Location: In person
