The Clinical Trial Assistant provides support to the clinical operations department to assist with execution and maintenance of clinical studies. Acts as a central support for the clinical team for designated project communications, correspondence, and associated documentation. Maintains, updates, and may establish various databases for clinical activity tracking. Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites.
Support the team in ensuring that quality clinical trials are conducted per protocol, in a timely fashion, and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and established study budgets.
Support the study team with start-up activities, enrollment, site management, data collection, data reviews, site feasibility, database lock, etc.
Provide logistical support for Study Managers and study team to assigned study
Create, update and maintain public clinical trial listings/postings (eg., www.clinicaltrials.gov)
Create and maintain study specific contact lists
Create and maintain tracking spreadsheets to monitor key study activities (eg., study startup, patient enrollment, data quality, etc.)
Maintain clinical trial insurance policies (includes liaising with insurance vendors, obtaining and reviewing policies for new studies, tracking and renewing expiring insurance certificates, etc.).
Independently maintains the internal Trial Master File (TMF) in accordance with the DIA's reference model and periodically reviews the TMF(s) being maintained by the Contract Research Organization (CRO) to ensure accuracy, completeness and adherence to the DIA's reference model.
Ensure that all essential study documents (generated by Clovis, CRO and study sites) are tracked and filed in a timely manner
Assist with creation of study specific tools and manuals to ensure timeliness, standardization and control of data quality.
Track review and finalization of monitoring visit reports. Assist with review of monitoring visit reports if requested
Review site regulatory and essential documents to approve initial shipment of study drug upon request
Prepare agenda, minutes and action items for clinical meetings, as requested
Assist with ensuring that investigator payments are accurately accrued (by Clovis or CRO) and confirm that sites are paid in a timely manner. Assist in reconciling and obtaining overdue invoices from sites.
Assist with Investigator Meeting preparations and planning (includes liaising with meeting planner to facilitate registration, development of agenda, travel, venue, F&B, etc.).
Assist with preparations for other meetings (eg. CRO Face to Face meetings, Investigator Update meetings, etc.)
May review informed consent forms, case report forms, study manuals, and other clinical trial materials as requested.
May assist with study feasibility assessments for new protocols
Assist in aspects of evaluating, selecting, and managing study sites
Assist with vendor management and associated logistics, as assigned
Review/monitor study drug inventory levels through IXRS reports and initiate drug shipment requests with Supply Chain, as needed
Perform QC of critical study documents (eg., protocols, protocol amendments, investigator brochure, clinical study reports, etc.), as requested
Participate in SOP development/review, if requested
Compile appendices for Clinical Study Reports, if requested
Perform administrative tasks to support team members with clinical trial execution, as needed
Assist with other operational activities, as requested
B.A./B.S. in a relevant scientific field experience
0 - 2 years relevant industry experience, CRA preferred
Service oriented approach, flexible and proactive, and open to change
Equipped with excellent planning, problem solving, and organizational skills
Excellent verbal, written communication and interpersonal skills
Perform activities in a timely and accurate manner
Attention to detail and accuracy in work
Work according to procedures, rules and regulations
Positive, self-starter, able to multi-task, and thrives under pressure
Able to work across multiple projects and prioritize tasks as required
Strong Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
Knowledge of ICH/GCP, some clinic research experience a plus
This individual must be highly motivated and enjoy working in a fast paced, challenging matrix environment. Must also be able to interact cross-functionally and externally with consultants, investigators, and study coordinators. Must be flexible relative to responsibilities since Clovis is a small company and job scope/role will inevitably evolve as the company grows and matures.