1+ months

Biospecimen Clinical Operations Specialist

Kelly Services
San Francisco, CA 94103
Kelly Scientific Resources is a specialty service of Kelly Services. As the world's largest provider of HR solutions to the scientific community, Kelly Scientific Resources is focused exclusively on placing skilled scientific professionals in contract, contract-to-hire, and full-time science jobs across a full spectrum of related industries and disciplines. Our scientists contribute to the research and development of therapeutics that change the lives of those affected with disease. We have an exciting contract opportunity in San Francisco for a **Biospecimen Clinical Operations Specialist** to join a leading biotherapeutics client.

**Biospecimen Clinical Operations Specialist**

***IMPORTANT*** The is a role in end-to-end biospecimen management for clinical trials.

Candidates ***MUST HAVE***

1) Managed biospecimens for clinical trials

2) Previously worked with clinical study teams in clinical trial study start-up.

3) Proven past experience in working on clinical trial protocols, ICFs, eCRFs

4) Experience executing on a biomarker sampling plans for clinical trials

5) Working with central labs in study start-up ie SOW experience and managing/tracking biospecimens during a trial

CORE RESPONSIBILITIES: The primary responsibilities of the BSO Contractor are to support TD and clinical teams in the implementation and maintenance of biospecimen management strategies for often complex, global clinical studies in each of the following areas under minimal supervision:

1. Biospecimen operations: Maintain knowledge/status of assigned clinical protocols and be able to follow good clinical practices (GCP), standard operating procedures (SOPs) and working procedures (WPs). Might be called upon to assist in the authorship of SOPs and WPs. Be able to handle, identify and resolve complex biospecimen-related/site issues and implement viable solutions in a timely manner. Play a key role in planning and designing clinical trial and biospecimen operations support internally and externally.

2.Biospecimen management: Utilize software tools to track biospecimens, identify discrepancies, verify and document consent, and ensure compliant utilization of biospecimens by following written procedures. Maintain regular metrics of biospecimen activities for studies that he/she supports. Follow up and resolve discrepancies through communication with study team, sites, or CROs/vendors within specified timeframes.

3.Clinical study teams: Plan/design biospecimen handling logistics and review biomarker-related clinical documents clinical protocols, ICFs, CRFs for successful study start-up. Create and maintain biospecimen laboratory manuals and provide hands-on biospecimen processing training at clinical sites. Support clinical and/or CRO to review supporting biospecimen documentation, labels, requisition forms and manifests to ensure documented sample chain-of-custody and the rapid reconciliation of biospecimens.

4. CROs and Vendors: Work with manager and clinical development teams to plan/design biospecimen handling logistics with preferred vendors on the manufacture of sample collection kits and execution of associated logistics; will be expected to take on a primary role in working with scientists and analytical laboratories on generating work order requests, work specifications and logistics.

KNOWLEDGE/SKILLS/ABILITIES (KSA's): In addition to above listed **MUST-HAVEs**, the incumbent should have proficient skills in each of the following areas and have demonstrated application in the context of clinical trials and biospecimen management.

Clinical Trials: Proficient knowledge of FDA regulatory requirements and GCP; have a demonstrated, intuitive understanding of clinical trials.

Scientific/Laboratory Skills: Proficient knowledge of relevant therapeutic and technical areas; demonstrated understanding of laboratory techniques in the life sciences; demonstrated understanding of principles in clinical research and clinical procedures involving blood/biopsy collection, handling and processing.

Biobanking: Understanding of global biobanking issues; proficient experience working in organizations adhering to quality standards and working with regulations pertaining to general biospecimen transportation requirements.

Drug Development: Proficient understanding of the drug development process.

Professional inter-personal skills and excellent oral/written communication. Experienced in presenting logistics and processing instructions, including basic scientific and clinical content, to internal and external audiences.

Basic leadership skills in conflict management, facilitation and negotiation.

Proficient computer skills in Microsoft Office.

Experience with databases and intermediate-level Excel a plus.

Up to 20% travel to clinical sites to train sites on biospecimen procedures.

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect
with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.


Posted: 2019-01-14 Expires: 2019-03-16

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Biospecimen Clinical Operations Specialist

Kelly Services
San Francisco, CA 94103

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