Job Description
Job Description
Yowei Therapeutics and Yowei Oncology are stealth-stage life-sciences companies working closely with CSBio to advance peptide-based clinical programs. Their work spans longevity and peptide therapeutics, clinical trials, evaluation of a 503A pharmacy model, personalized synthetic neoantigen peptide oncology programs, and supporting microbiology and laboratory capabilities. Together, they are building the clinical, pharmacy, data, laboratory, and operational infrastructure needed to responsibly translate peptide programs into patient-facing studies and services. Both companies expect to remain in stealth through Q1 2027.
CSBio is a peptide contract manufacturing founded in 1993. CSBio initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, CSBio opened a custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, CSBio opened a peptide production facility in Menlo Park, CA and in 2014, CSBio expanded production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, CSBio passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, additional cGMP clinical production capacity was added in Milpitas, CA.
Yowei Therapeutics is seeking a detail-oriented Clinical Research Coordinator to manage day-to-day study coordination for early clinical and longevity programs. Core duties are included below.
Job Duties:
- Coordinate study startup, participant screening, scheduling, visits, follow-up, and closeout activities under investigator and protocol oversight.
- Maintain regulatory, delegation, training, screening, enrollment, visit, specimen, investigational-product, issue, and action logs as assigned.
- Prepare visit packets and confirm consent, eligibility, orders, supplies, equipment, staff, and vendor readiness before each visit.
- Collect and enter accurate study data from approved sources into EDC, CTMS, electronic source, or other controlled systems; resolve queries promptly.
- Coordinate specimens, laboratories, imaging, pharmacy, vendors, couriers, and chain-of-custody requirements.
- Track adverse-event and deviation documentation and escalate medical or safety issues immediately to qualified personnel; do not make independent clinical decisions.
- Support participant communication, reminders, reimbursement documentation, retention, and approved education materials.
- Support monitoring visits, audits, inspections, document requests, and corrective actions.
- Maintain confidentiality, version control, data quality, and complete records; surface risks and missed deadlines early.
- Prepare concise weekly status reports on enrollment, visits, data completeness, deviations, vendor issues, and decisions needed.
- Collect, process, label, store, and coordinate shipment of clinical specimens when appropriately trained, credentialed, and authorized.
Requirements
- Bachelor’s degree in life sciences, health, psychology, public health, or a related field, or equivalent relevant experience.
- 2+ years of clinical-research, site-coordination, patient-services, or regulated health-program experience.
- Working knowledge of GCP, informed-consent documentation, source records, data entry, privacy, and protocol adherence.
- Strong organization, participant communication, documentation, and follow-through skills.
- Ability to work on site and manage multiple participants, visits, vendors, and deadlines.
Preferred Qualifications:
- Phlebotomy experience strongly preferred, including venipuncture, specimen labeling, processing, handling, and chain-of-custody documentation. A current California phlebotomy certificate or another credential authorizing venipuncture is required if the coordinator will perform blood draws.
- ACRP or SOCRA certification.
- Experience with early-phase, oncology, metabolic health, longevity, infusion, decentralized, or investigator-initiated research.
- Experience with EDC, CTMS, eRegulatory, electronic source, specimen tracking, or participant-engagement systems.
Benefits
- Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
- Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
- Disability insurance 50% standard employer paid.
- 401k 10% 1:1 match
- PTO policy. 10 days PTO
- Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
- Carpool, clean air vehicle, and cell phone reimbursement
- Employee rewards and recognition program
- Company organized social events
- Quarterly sponsored team building activities