Senior Clinical Research Assistant
The Senior Clinical Trial Assistant (SCTA) position is a key support role within Clinical Development, undertaking essential coordination activities for the study team. SCTA will work closely with the Hiring Manager and other members of the Clinical team. The SCTA is expected to carry out all assigned activities in an efficient and effective manner in support of the overall study timelines and to help ensure all deliverables meet with the corporate objectives.
Role and Responsibilities
- Provide administrative support to the Clinical Development and Clinical Operations Departments (e.g. expense reports and travel coordination).
- Under the guidance of the Hiring Manager, track vendor management activities (e.g., track tissue samples) and provide updates to the clinical team.
- Participates in clinical team meetings, coordinates meetings/teleconference/WebEX. Prepare agendas, meeting minutes, study newsletter, and tracks action items.
- Set-up, track, file, maintain and archiving of trial master files.
- Ensure timely study entry and updates to ClinicalTrials.gov.
- Prepare study related materials for the training of internal and external staff.
- Assists clinical study team in the development, handling, distribution, filing and archiving of essential documents in the CTMS / eTMF.
- Assists with all aspects of initial study drug release including regulatory packet review and study-drug release (if required).
- Under Hiring Manager’s supervision work with sites and vendors to ensure compliance with overall clinical objectives and protocol.
- Reconcile vendor payments against executed contracts.
- Reconcile site payments against EDC and site contracts.
- Identifies and escalates issues appropriately and may perform other work-related duties as assigned.
- Responsible for ordering and shipping supplies in coordination with all phases of the clinical studies.
- Ensures proper drug shipments, and returns and assists with in-house reconciliation.
- Processes, logs and distributes completed case report forms.
- Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites.
- Assists department and helps with routine administrative tasks.
Qualifications and Education Requirements
- Bachelor’s degree or equivalent preferred with minimum of 2 years of related training or experience working in the Pharmaceutical or Biotechnology industry
- Understanding of relevant clinical affairs activities
- Basic knowledge and understanding of ICH/GCP guidelines and FDA regulations required
- General knowledge of medical terminology
- Experienced in both Paper and/or Electronic TMF maintenance and management of essential documents
- Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint, Outlook, and organization tools
- Experience with filing systems such as SharePoint, Dropbox, and Box are desirable
- Able to build effective working relationships throughout the organization internally and externally to achieve goals.
- Flexibility and willingness to solve problems that fall outside of immediate area of expertise
- Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
- Work independently in an interdisciplinary, fast-paced, often changing environment.
- Committed to the values of integrity, accountability, agility, and drive.
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