POSITION SUMMARY:
The Clinical Biospecimen Operations Associate executes oncology clinical research studies, including coordination of all operational activities required for tracking, testing and reporting clinical trial samples. This position will perform required job duties with oversight from the Pharma Operations Team Leader and will work closely with internal and external central testing laboratories, vendors, Data Management, Product Management, Engineering and external collaborators in compliance with the study protocol(s), SOPs, and applicable regulatory requirements.
PRIMARY RESPONSIBILITIES:
- Maintain oversight of all study sample operational activities including planning, coordinating and tracking clinical trial sample testing to ensure results are provided within agreed upon TAT
- Work with Data Management to develop and maintain dashboards and KPIs representing metrics and trends related clinical trial sample testing and the status of clinical studies and present to study teams and management teams, as needed.
- Meticulously track clinical trial samples from sample receipt to result reporting to investigator sites and/or external collaborators (and sample return, if applicable)
- Utilize operational and project management skills to anticipate, investigate and resolve issues to ensure deliverables and TAT are met; raise issues to Pharma Operations Team Leader
- Responsible for handling data files to support timely result reporting
- Review and provide input to clinical study protocol for sample collection requirements and alignment with the SOW, study plans and company policies
- Administer clinical trial supplies related to biospecimen collection, processing, shipment, and storage as, well as maintenance of associated tracking information
- Organize and plan meetings and provide agenda and meeting minutes as needed
- Assist in developing study plans (e.g. Communication Plan) and departmental and study specific SOPs and work instructions with SME
- Assist in the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements; set up and maintain study files in eTMF
- Monitor studies to identify protocol deviations or data discrepancies and issue data clarification forms, as needed
- Partner with other research and development groups at Natera to achieve deliverables
- This role works with PHI on a regular basis both in paper and electronic form and have access to various technologies to access PHI (paper and electronic) in order to perform the job.
- Employee must provide records of current training or complete training relating to HIPAA/PHI privacy, human subject’s protection, and GCP.
- Must maintain a current status on Natera training requirement including General Policies and Procedure Compliance and security training.
QUALIFICATIONS:
- BA/BS degree in life sciences, related field, or equivalent
- Minimum of 5 years of experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields
KNOWLEDGE, SKILLS, AND ABILITIES:
- Familiarity with biospecimen management, sample processing, and biobanking best practices
- Experience with clinical EDC systems
- Familiarity with the organization and structure of the Trial Master File (TMF)
- Competency in SOPs, ICH-GCP, FDA Regulations
- Proficiency in MS Word, Excel and PowerPoint
- Demonstrated ability to work independently
- Outgoing and confident demeanor
- Demonstrated analytical skills and ability to identify problems and propose solutions
- Detail oriented, with solid organization and time management skills
