Responsibilities :
- This is an onsite position responsible for providing sample management support to ligand binding analysis and FACS-based biomarker laboratories. The samples are collected from preclinical and clinical studies in various therapeutic areas including oncology, neuroscience, immunology, and virology.
- The Biomarker Associate I serve as a Bio-sample point of contact on assigned studies.
- Collaborate with biomarker scientists, clinical operation teams, project managers and laboratory managers to coordinates all aspects of bio sample operations with minimal supervision.
- Ensure all sample collections, storage and transfers are following protocols, regulatory requirements (ICH/GCP/GLP), ICF status, and project timelines.
- Identifies immediate needs on studies, projects, and tasks, and works closely with the lead Biomarker scientists on exploratory analysis activities and biomarker strategy.
- As part of the team, contributes to innovation and continuous improvement activities in bio-sample collection, processing, and transfers.
- Track Clinical and laboratory samples and follows up with sites/study team, vendors, and/or CRO to resolve queries, discrepancy, reconciliation, and data entry
- Execute and maintain processes for sample management, able to organize and manage large datasets, and provide regular summaries to team.
- Manage clinical bio-samples and storage equipment, including LN2 freezers.
- Collaborate with Clinical Operations, Discovery, CQA and IT, contribute to the development and efficiency of departmental Laboratory Information Management System (LIMS).
- Assist in the planning and organization of collection and shipping of bio-samples from investigator sites or centralized locations and subsequent delivery to analytical laboratories or company site.
- Partner with Biomarker Leads to ensure the delivery of bio-sample data in accordance with study timelines.
- Provide operation support for Senior Biomarker Associates and Biomarker Leads.
- Support relationships with laboratory vendors, provide input into trial-specific agreements and assess service level commitments of labs involved in sample analysis.
- Ensure issues are resolved or escalated in a timely manner.
- Assist to review laboratory vendor invoices to ensure appropriate work has been completed.
- Contributes to functional process and system improvements to ensure samples are collected, processed, and analyzed appropriately.
Qualifications :
- BA/BS in Biology, Pharmacology or equivalent, with/or 1 to 3 years of relevant industry experience.
- Proficiency in MS office including Word, Excel, PowerPoint, and other applications.
- Previous experience and proficiency in utilizing LIMS preferred.
- Previous HIPAA and/or Human Subject Protection knowledge preferred.
- Knowledge of processing and storage management of human bio-specimen preferred.
- Effective team player and ability to collaborate with cross functional clinical study teams.
- Ability to oversee bio-sample management activities across multiple clinical trials.
- Demonstrated ability to balance multiple priorities in a fast paced, team-based environment and work independently when necessary.
- Excellent written and interpersonal communication skills necessary to interface with outside vendors, consultants, and team members.
- Hands-on experience in handling clinical biological samples.
- Demonstrated strengths in planning, organizational, analytical skills, time management, problem solving, and attention to detail.
- Proven critical reasoning skills including the identification and resolution of complex problems.
- Experience in clinical research or bio-sample handling at either an investigational site, pharmaceutical/biotech company, or equivalent
California Fair Chance Act:Synectics Inc. will consider qualified applicants with a criminal history pursuant to the California Fair Chance Act. You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if Synectics Inc. is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. Find out more about the Fair Chance Act by visiting calcivilrights.ca.gov/fair-chance-act/.Benefits: Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics. Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st. Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification. Synectics is an equal opportunity employer.