Job description
Position Highlights:
The Pathology Clinical Research Analyst is responsible for initiating the startup activities of clinical research protocols as they relate to clinical research sampling supported by Pathology and seeing them through to activation, in accordance with Department of Pathology and institutional standards.
Provides oversight of the development of study-related documents, anticipates potential obstacles to activation and pro-actively addresses them to avoid delay. Interacts with leadership of other functional areas within research administration which are involved in the startup processes.
Establishes and builds business relationships to increase positive interactions with disease program study activation coordinators, shared resources staff, study sponsors, clinical trial office, clinical trial business office and other applicable research organizations.
The Ideal Candidate:
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, etc.)
- Able to interact with a variety of professionals and team members in multiple hospital departments
- Strong interpersonal and communication skills, both oral and written
Responsibilities:
- Review completed pre-site checklists and ensures CTO information packets to sponsors include latest core releases of information/quick facts, and ensure timely distribution of pre-site paperwork and materials, such as lab manuals, flowcharts and waybills being on site in preparation for activation.
- Attend pre-site visits (PSV) for preliminary feasibility, site initiation visits (SIV) for gathering essential information related to core support
- Attend Operational Contact Task Meeting to inform those contacts about study preparations and working with the Lab Project Specialist to troubleshoot any issues periodically during the activation process
- Coordinate with the disease program study team for any ad hoc meetings necessary after SIVs
- Tracks project progress
- Provides follow-up with continuous communication with all applicable internal staff and external customers for the duration of the activation process to ensure timely completion of project tasks which may include Pathology research team, Coordinator Study Activation (CSA), and Clinical Trials Coordinators (CTC) for the disease program impacted, Tissue Code (TC) and industry sponsors and vendors
- Responsible for creating independently and/or in collaboration with Pathology staff on multiple study-related documents or tracking sheets including Protocol Quick References, Supply Chain Catalogs, Service Request Templates, Kit Pulling Flow Chart, Protocol by Vendor tracker, and other documents as needed
- Conduct special department related projects as they are assigned
- Provide training and consultation to investigators and research staff on regulations and policies related to Pathology Research
- Consults with investigator on the development of initiated protocols and budget implications
Credentials and Experience:
- Bachelor’s Degree in Business Administration, Healthcare, Biosciences or related field.
- Minimum of two (2) years working with clinical research data or clinical oncology research coordination, preferably in an academic setting.
- Good understanding of project management and possesses strong problem-solving, communication and leadership skills.
Preferred:
- Master’s Degree in Business Administration, Healthcare, Biosciences or related field.
- Two years of experience in clinical research management
- Experience in budgeting
- Advanced experience in Excel (Pivot Tables, Index, etc.)
- Knowledge of healthcare compliance and federal regulations related to clinical research
- Knowledge of research regulatory environment
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