Job details

Specialist, Biosample Operations, Contractor (Office OR Remote)

The 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% domestic and international travel required.

RESPONSIBILITIES

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.
Assist the Manager with overseeing sample collections, processing, storage, and reconciliation, with the goal of maximizing sample accrual and quality.
Review informed consents to confirm sample language is consistent with planned study objectives and analysis.
Review clinical study protocols, laboratory documents, case report forms and laboratory scopes of work documents with guidance from sample managers.
File necessary vendor laboratory documents for the Trial Master File (TMF) as applicable.
Contribute to the development and review of clinical site training materials and guidance documents.
Support 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.

QUALIFICATIONS

Bachelor’s degree, preferably in a scientific field.
0-2 years Clinical trial experience in the pharmaceutical or health care sectors or equivalent academic setting.
Experience with ICF review.

SKILLS/ABILITIES

Understanding of ICH GCP and GLP guidelines.
Prior laboratory or other sample handling experience preferred.
Previous experience working within Biosample Operations would be a distinct advantage.
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%.

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. EOE/AA/Vets

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By Arcus Biosciences

Founded in 2015, Arcus Biosciences is a clinical-stage biopharmaceutical company that researches and develops cancer immunotherapies. their headquarters is located in Hayward, California.

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FUNDING

Private

DEPARTMENTS

Operations

SENIORITY LEVEL REQUIREMENT

Early

INDUSTRY

Health Care

TEAM SIZE