Clinical Trial Assistant/Clinical Research Associate
Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to eradicate cancer globally. The company’s existing pipeline consists of five development-stage assets including two novel humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and three targeted therapies against uncontrolled growth signaling pathways.
Clinical Trial Assistant/Clinical Research Associate
Based in Foster City, CA, the Clinical Trial Assistant/Clinical Research Associate will provide clinical study support for one or more complex clinical studies/programs. This position assists clinical operations team and other personnel to ensure efficient delivery of clinical trials in a matrix environment. Will assist in managing vendors, clinical systems, document repository systems, Trial Master File, and managing or leading the day-to-day operations of assigned tasks to ensure completion per established project team goals and milestones in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
This position works in a cross-functional environment to contribute to corporate goals to progress the company’s portfolio of products. This work is accomplished with supervision. A person that is a motivated individual, able to multi-task, and takes initiative while working independently with minimal supervision upon project assignment. This position may support start-up and close-out site activities.
Primary Duties and Responsibilities
- Assist in study start-up, maintenance, and closure activities.
- Support regulatory activities including regulatory documents review.
- Manage the Study Trial Master File (TMF) plan.
- Maintenance of Study Document Repository System.
- Manage IP inventory at the depot.
- Proactively identify and resolve issues that arise during study conduct.
- Provide administrative assistance in site selection, study implementation and ongoing coordination of study sites, trial documentation and investigator communications, either directly or via CROs.
- Assist Clinical Trial Managers with set-up and management of central labs and study vendors including oversight of sample and imaging collection and analysis, as required.
- Support clinical trial-specific tasks such as review of regulatory documents for site activation and investigational product release.
- Assist in managing Study Drug Supplies, Labeling and Shipment from Depot to Sites.
- Support the development and review of required clinical documents, including Monitoring Plans, Case Report Forms, Protocol Deviation Management Plans, and other documents as needed.
- Support the review and tracking of monitoring visit reports to assist in ensuring clinical trial site performance, quality, and compliance.
- Assist with the preparation, organization, and facilitation of internal and external meetings.
- Assist in the management of designated activities outsourced to CRO's and vendors as required.
- Assist in the compilation and review of trial management reports from internal and external tracking systems.
- Assist in managing and tracking vendor-specific payments and invoices.
- Participate in and may facilitate cross-functional study team meetings.
- May facilitate and perform updates and maintenance activity of study information in ClinicalTrials.gov postings.
- May perform accompanied visits with other internal or CRO personnel to assist in monitoring site compliance and review of routine regulatory documents.
- Assist in implementation of appropriate systems, standards and processes to enable quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.
- May participate in the development of clinical and corporate procedures.
- Provide support to both internal and external departmental members when necessary.
- Communicate and collaborate with other functional groups including Regulatory Affairs, CMC, QA, Pharmacokinetic, Biometrics, Safety and Medical Writing to enable efficient management of study activities.
- Perform other duties as assigned by management.
- Minimum Bachelor’s Degree in a scientific field of study.
- Minimum of 2 years clinical trial support experience or relevant experience in the medical / scientific area.
- Working experience in managing TMF and familiarity with DIAs Trial File Index structure.
- Working knowledge of FDA and international regulations, including CFRs, ICH Guidelines, GCP and the clinical trial strategy.
- Experience with clinical systems and trackers in clinical trial operations and clinical trial logistics.
- Experience in managing Study Drug supplies.
- Understanding of clinical trial vendor and site contracts, invoicing and payments.
- Comfortable working in a start-up environment. Thrives in a fast-paced, highly collaborative, multi-disciplinary team setting.
- Ability to manage, prioritize, and organize clinical trial projects with supervision.
- Strong attention to detail.
- Strong written, oral, and interpersonal communication skills.
- Computer skills, including Microsoft Office Suite.
- Ability to travel up to 25% domestically.