- Expertly support the Biosample Managers to deliver the sample strategy for clinical trials within the requirements of quality, and ethical and regulatory standards, including ICH/GCP/GLP.
- Oversee sample collections, processing, storage, and reconciliation, with the goal of maximizing sample accrual and quality, with minimal guidance from the sample management lead.
- Proficiently review clinical study protocols, informed consents, laboratory documents, case report forms, and laboratory scopes of work documents with minimal guidance from Biosample Managers.
- Review and file necessary vendor laboratory documents for the Trial Master File (TMF) as applicable.
- Expertly assist in the development and review of clinical site training materials and guidance documents.
- Support with minimal assistance in developing reports on critical metrics around performance and sample chain of custody.
- Collaborate with cross-functional study teams to ensure delivery of samples per project milestones.
- Contribute to innovation and process improvement activities for Biosample Operations and/or Clinical Operations functions.
- Mentor junior Biosample Specialists.
- Bachelor's degree, preferably in a scientific field.
- 2+ years of clinical research experience.
- 1-2 years clinical research central laboratory management experience or Biosample Operations experience.
- Understanding of ICH GCP and GLP guidelines.
- Demonstrated ability to establish priorities, work with a strong sense of urgency and collaborate (interpersonal, relationship management) effectively with the study team, cross-functional team members and external partners/vendors.
- Self-motivated, assertive, and able to function both independently and as part of a team.
- Strong interpersonal and negotiation skills.
- Proficiency with Microsoft Office, advanced Microsoft Excel skills preferred.
- Effective verbal and written communication.
- Proven problem solving and decision-making skills.
- Ability and willingness to travel ~10%.
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Sr. Specialist, Biosample Operations - Brisbane, United States - Arcus Biosciences, Inc.
1 week ago
Description
The Senior Specialist, Biosample Operations will assist Biosample Managers in planning, implementing, managing, and driving biological sample logistics across Phase I-IV Clinical Trials.
This role is an essential member of the Clinical Operations function and must be able to collaborate with the cross-functional teams both internal and external.
This position is remote or if in the bay area in-house/hybrid, depending on experience. Approximately 10% travel required.RESPONSIBILITIES
QUALIFICATIONS
The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data.
In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package.
Additional information about our total rewards program can be found here:Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.
Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.
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