- Support assigned study teams with TMF set-up, maintenance, ongoing quality control reviews, and final reconciliation of study documents
- Routinely monitor TMF inspection readiness for assigned studies
- Assist Study Lead in review of invoices for assigned studies
- Contribute to development and finalization of Pharmacy Manual and associated forms, templates and processes
- Assist study lead with investigational product and ancillary supplies management, accountability and reconciliation activities
- Support IRT system set-up, testing, and on time activation including review of specifications, and user manuals.
- Collect and/or review Essential Documents from investigational sites
- Review site-level ICFs for accuracy and compliance
- Lead study specific tasks such as investigator identification, feasibility, and site activation
- Review monitoring visit reports for accuracy and completeness
- Attend or conduct site selection, initiation interim monitoring visits, close-out visits and co-monitoring oversight visits
- Contribute to the development of study-level documents (study templates, manuals, guides, newsletters, case report forms (CRFs), study master informed consent forms, study-level forms and reference materials, etc.)
- Assist in the preparation and review of site-level forms and templates (eg screening/enrollment logs, site signature/responsibilities form, site monitoring log, etc.)
- Assist in the preparation of training materials and presentations related to study execution
- Provide updates on study/site status as needed to ensure timely study entry and updates are reflected on or equivalent
- Perform periodic data review as requested by the Study Lead
- Support Study Lead in preparing materials for study-wide meetings (eg investigator meetings, interim update meetings, data safety committee meetings, etc.)
- Prepare and present updates at team meetings as assigned by Study Lead
- Coordinate external service provider (e.g. central lab, recruitment, homecare, etc.) set-up and on-time activation (e.g. specifications, user manuals, etc.) as delegated by the Study Lead
- Work closely with CRO to plan for execution of study start-up and ongoing study execution activities as assigned by the Study Lead
- Provide guidance, mentorship and oversight to more junior Clinical Operations staff members
- Identify, and lead process improvement projects within the Clinical Operations department
- Recommend modifications to SOPs/work instructions (WIs) when necessary to improve compliance or efficiency
- Maintain compliance with assigned procedures, guidelines, study plans and applicable regulatory requirements
- Minimum of five (5) years in clinical research and development
- Minimum of three (3) years onsite monitoring/site management experience
- Experience managing/supervising vendors
- Highly proficient knowledge and understanding of ICH-GCP
- Strong organizational skills and attention to detail
- Excellent site management and monitoring skills
- Proficient software skills (Outlook, Word, Excel, Power Point, MS Project)
- Proficient in Veeva eTMF and Medidata EDC
- Ability to perform key duties in a timely manner and with minimal supervision
- Ability to think critically (analyze, extrapolate knowledge and information and problem-solve)
- Ability to work effectively independently and in a collaborative team environment
- Must be able to work collaboratively and professionally with team members and outside vendors such as CROs
- Excellent interpersonal, verbal and written communication skills
- Ability to multi-task and prioritize appropriately
- Displays high level of professionalism and understands need for confidentiality in all aspects of position
- 4-year college degree
- CRA certification
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Description
The PositionThe Sr. Clinical Research Associate (Sr. CRA) provides support to Study Lead(s) in clinical study planning, execution and management.
The primary purpose of the position is to support the COM/Study Lead in study set-up, execution, oversight, and closeout activities in compliance with the clinical protocol, regulatory requirements, ICH GCP guidelines and governing policies & procedures.
ResponsibilitiesRequirements:
Preferred:
