The Senior Clinical Trial Specialist (SR CTS) supports moderately complex clinical trial activities in support of the Clinical Trial Manager. The SR CTS works closely with the clinical trial team to ensure site related start-up through close-out activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's. The SR CTS may assist with vendor oversight and management. They will identify issues in a timely manner and escalates to management as appropriate. The SR CTS may complete monitoring visit report review and perform co-monitoring. The core duties and responsibilities of the SR CTS are delineated below.
- Manages Site Essential Documents review during study start-up, maintenance and close-out period
- Prepares study documents and manuals (i.e. consent forms, site instructions, study specific material such as the Manual of Operations, Pharmacy binder, etc.)
- Ensures tracking of essential documents are received and filed in the TMF, reviews site documents for accuracy; provides clinical team support with TMF filing and management
- Ensures tracking of patient status throughout the study at investigative sites
- Review and approve trip reports, track data query reports, site visit metrics, and overall site performance
- May perform site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with local CRAs and CRO personnel.
- Reviews data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
- Assist in the preparation of, and may present at investigator vendor meetings and workshops
- Actively involved in organization of team and vendor meetings including preparation of agenda/ minute taking and updating any risk/ issue/ decision logs
- Actively involved in the performance of study feasibility assessments
- Adheres to study timelines, quality, and budget for assigned studies
- Provides rapid action to address both internal and site QA findings from audits
- Coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation
- Tracking and maintaining study status updates internally and externally
- Assist and support data query process
- Routinely participates in department and clinical trial team meetings and participate in collaborative efforts (e.g. protocol development, CRO selection, departmental initiatives, etc.)
- Be able to work cross-functional with
- Provides oversite of CRO and vendor activities
- Review and verification of contacted vendor activities including vendor invoice review
- Bachelor’s degree preferred
- 5 or more years industry experience from Pharmaceutical, Biotechnology or Contract Research Organization (CRO), to include at least 1 years of site management experience
- Previous site monitoring experience is preferred
- Clinical experience with the CNS therapeutic area is preferred
- Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
- Understanding of study phases and general knowledge of how they apply to clinical development
- Demonstrated ability to work independently and in a team environment
- Advanced knowledge of Word, Excel, and PowerPoint.
- Strong verbal and written communication skills required.
- 15% - 20% travel may be required
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.