Clinical Biomarker Specimen Specialist - FSP at Parexel

Southport, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

0.0

Posted On

15 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Time Management, Detail Oriented, Communication Skills, Interpersonal Skills, Flexibility, Organizational Skills, Data Management, Biomarker Knowledge, GxP Knowledge, Clinical Study Experience, Specimen Management, Vendor Oversight, Oncology Knowledge, LIMS Experience, FDA Regulations Knowledge

Industry

Pharmaceutical Manufacturing

Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Clinical Biomarker Specimen Specialist works collaboratively with the Clinical Biomarker Operations Manager, Study Managers, and Scientific stakeholders to ensure timely and smooth collection, transfer, and testing of clinical trial specimens. This role will ensure full chain of custody is maintained through the specimen lifecycle from collection through testing and final sample disposition. This role requires clinical study, specimen management, and project management experience. As well as knowledge of GxP and vendor-sponsor best practices. Key Accountabilities: Oversight of programming activities: Clinical specimen management from collection through testing and final disposition Ensures compliance with clinical protocol and informed consent. Maintain chain of custody for specimens Organize and oversee the collection, shipping and proper storage and maintenance of clinical specimens Resolve and/or triage specimen queries from sites or vendors Ensuring proper documentation of specimen destructions are obtained and filed appropriately Collaborative relationships: Collaborate on implementation and maintenance of specimen tracking system Work collaboratively with internal key stakeholders (e.g. Project Management, Clinical Operations, Biomarker and Bioanalytical Scientific Study Leads, Data Management) to ensure proper alignment and study-level execution of specimen management Compliance with Parexel standards: Complies with required training curriculum Completes timesheets accurately as required Submits expense reports as required Updates CV as required Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: Effective project management and time management skills; able to prioritize successfully Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession Detail oriented; performs quality and accurate work with minimal oversight Excellent written/verbal communication skills Can identify opportunities for efficiency improvements and simplification, recognizes appropriate. Resources for deliverables, has effective organizational skills Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively Flexible, easily adapts to change, and is energized by challenges and problem-solving Can learn new skills and knowledge, able to offer new ideas but also willing to adapt style to existing process as appropriate Other competencies include managing complexity and ambiguity, decision quality, collaborates, cultivates innovation, customer focus, nimble learning, balances stakeholders, and action oriented Proficiency in written and spoken English – required Proficiency in local languages (as applicable) Knowledge and Experience: Years of experience: 2-5 years; dependent on level of related skills and education Laboratory background and/or strong knowledge of commonly tested biomarkers in the Oncology setting, latest and advanced analytical tools and assays Proficiency with data sets and Excel, understanding of data relationships and metadata Confident in overseeing vendors and communicating with experts to drive quality deliverables Preferred: Previous biobanking, sample tracking and handling experience Previous LIMS (Laboratory Information Management System) experience Working knowledge of the clinical drug development process Working knowledge of the Food & Drug Administration (FDA) regulations, International Council for Harmonization (ICH) Good Clinical Practice (GCP) guidelines, Study Data Tabulation Model (SDTM), Clinical Data Interchange Standards Consortium (CDISC), database development and User Acceptance Testing (UAT). Oncology experience and/or working knowledge Proficiency with timeline management Education: Bachelor of Arts/Bachelor of Science in relevant field, or other relevant experience/qualification EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Responsibilities

The Clinical Biomarker Specimen Specialist ensures timely and smooth collection, transfer, and testing of clinical trial specimens while maintaining the chain of custody throughout the specimen lifecycle. This role involves collaboration with various stakeholders to ensure compliance with clinical protocols and effective specimen management.