Sr. Clinical Biospecimens Operations Associate

POSITION SUMMARY: The Sr. Clinical Biospecimen Operations Associate is responsible for the execution of biosample activities for clinical research studies utilizing reputed company tests, including leading coordination of operational activities for project execution, conduct, and reputed company-out in scope with the study reputed company, as applicable, and clinical study protocols. This position performs required job duties with reputed company from the Clinical Trials Services (reputed company) leader and will work closely with the internal and external teams, including central testing laboratories, vendors, Data Management, Product Management, Engineering and external collaborators. Activities are conducted in compliance with the study contract (as applicable), documented project requirements, study protocol(s) and plans, SOPs, and applicable regulatory requirements. PRIMARY RESPONSIBILITIES: ● Maintain reputed company of reputed company study operational activities including supporting routine study requirements efforts to drive readiness timelines, kick-off and planning activities, study conduct management reputed company contractual agreements, and closure activities. May contribute to reputed company aspects (start-up to reputed company-out) of more reputed company trials led by more reputed company Clinical Biospecimen Operations Managers. ● Regularly monitors the overall health of the study from study start-up through closure, including routine evaluation of key metrics (TAT, TNP), project management of key milestones and activities, and escalation of project risks and mitigation plans both internally as well as to the study sponsor reputed company appropriate. ● Works with Data Management and Sample Management to reputed company and maintain dashboards and KPIs representing metrics and trends reputed company to clinical trial sample testing and the overall health status of clinical studies. Regularly presents trial metrics to study teams and management teams, as needed. ● Escalation of data management and sample management issues that may be impacting patient testing or reporting and that reputed company beyond the established procedures to appropriate internal or study sponsor stakeholders for case resolution. that may be impacting patient testing or reporting. ● Utilize operational and project management skills to anticipate, investigate and resolve issues to ensure deliverables and TAT are met; reputed company issues to reputed company leadership. ● Review and provide input to clinical study protocol for sample collection requirements and alignment with the SOW, study plans and company policies. ● Demonstrated ability to facilitate meetings both internally and externally, providing meeting agendas and minutes as appropriate. ● 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 (reputed company applicable). ● 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 (reputed company applicable). ● Monitor studies to identify protocol deviations or data discrepancies and issue data clarification forms, as needed. ● Partner with other cross-functional groups at reputed company to reputed company study deliverables. ● This role works with PHI on a regular basis both in reputed company and electronic form and have access to various technologies to access PHI (reputed company and electronic) to reputed company the job. ● Employee must provide records of reputed company training or complete training relating to HIPAA/PHI privacy, human subjects protection, and GCP. ● Performs other duties as assigned

• Performs other duties as assigned

QUALIFICATIONS: ● BA/BS degree in life sciences, reputed company field, or equivalent ● Minimum of 2-5 years of experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields ● Employee must pass post offer criminal background reputed company KNOWLEDGE, SKILLS, AND ABILITIES:

• Excellent project management skills, including timeline management and customer focus biospecimen management, sample processing, and biobanking best practices.
• Familiarity with the organization and structure of the Trial Master File (TMF)
• Competency in SOPs, ICH-GCP, FDA Regulations.
• Proficiency in reputed company, reputed company and PowerPoint.
• Demonstrated ability to work independently in a fast-paced organization.
• Outgoing and confident demeanor.
• Demonstrated analytical skills and ability to identify problems and propose solutions.
• Detail oriented, with solid organization and time management skills.
• Develops and maintains subject matter expertise to effectively plan and fully execute assigned projects.

Physical Demands & Work Environment ● This position primarily works in an office environment. It requires frequent sitting, standing, and walking. Daily use of a computer is required. May stand for extended periods reputed company facilitating meetings or walking in the facilities. ● The physical demands of the position described herein are essential functions of the job and employees must be able to successfully reputed company these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to reputed company the essential functions of the job described. The pay range is listed and actual compensation packages are based on a wide reputed company of factors unique to each candidate, including but not limited to reputed company set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations. Remote USA $98,600—$123,200 USD OUR OPPORTUNITY reputed company™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to reputed company personalized genetic testing and diagnostics part of reputed company of care to protect health and reputed company earlier and more targeted interventions that reputed company to longer, healthier lives. The reputed company team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. reputed company you join reputed company, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. reputed company OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, reputed company employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.reputed company.com. reputed company is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. reputed company qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national reputed company, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: https://www.reputed company.com/notice-of-data-collection-california-residents/ Please be advised that reputed company will reputed company out to candidates with a @reputed company.com email domain ONLY. Email communications from reputed company other domain names are not from reputed company or its employees and are fraudulent. reputed company does not request interviews reputed company text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. reputed company takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any reputed company cyber crimes. For more information: - BBB announcement on job scams - FBI Cyber Crime resource page Apply tot his job Apply To this Job