Project Assistant - Aditi Consulting
San Diego, CA 92121
About the Job
Summary:
As a member of the Biomarker Clinical Assay and Technology (BCAT) group within the company Oncology Division, the successful candidate will play a critical role in supporting Translational Oncology strategies through operational and technical assistance for the Biomarker Clinical Assay Lead (BCAL) overseeing and managing external and internal partners involved in the implementation of clinical trial biomarkers sample analyses.
POSITION RESPONSIBILITIES:
EDUCATION AND EXPERIENCE:
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on a number of factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
As a member of the Biomarker Clinical Assay and Technology (BCAT) group within the company Oncology Division, the successful candidate will play a critical role in supporting Translational Oncology strategies through operational and technical assistance for the Biomarker Clinical Assay Lead (BCAL) overseeing and managing external and internal partners involved in the implementation of clinical trial biomarkers sample analyses.
POSITION RESPONSIBILITIES:
- Support Biomarker Clinical Assay Lead (BCAL) by providing document management and process management support
- Distribute documents to vendors, track distribution and acknowledgement/response from vendors
- Create and maintain master document list for closeout studies
- Enter vendor and bioanalytical report information into BCAT systems.
- Keep track of vendor assay validations, biomarker assay reports and sample disposition documents.
- Request regular updates to vendor contact information
- Assist with Vendor Evaluation data collection
- Maintain and track vendor qualification and oversight documentation
- Submission of documents to global document management system (GDMS) Report Loading Team
- Support BCAL in operational oversight for their supported studies
- Track vendor Master Service Agreement (MSA) expiration dates, vendor contact information, Vendor Oversight Plan (VOP) status, CLIA status, QMSO9 status, CP102 status, and qualification/audit visits
- Work with company Trial Master File (PTMF) study owners to ensure proper attributes and functional line information is accurate for all BCAT documents loaded to PTMF
EDUCATION AND EXPERIENCE:
- Bachelor’s degree or Master’s degree in biology, molecular biology, biotechnology, or biochemistry
- Proficiency in Microsoft Office and Communication tools, including Cloud-based services
- Attention to detail and ability to think and act proactively is critical
- Demonstrated ability to work in a highly matrixed environment, and execute multiple projects simultaneously
- Good understanding of inter-dependencies and functional line responsibilities
- A minimum of 2 years related clinical or research Lab experience.
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on a number of factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
Source : Aditi Consulting
