Senior Clinical Trial Associate - Boston, MA Position
Summary: Project support: Responsible for coordination, tracking and management of logistics in support of clinical trials. Operational support: Responsible for special projects supporting departmental operations.
Duties and Responsibilities:
- Clinical study team member: Reports to the Senior Director of Clinical Operation and works closely with the Clinical Trial Manager (CTM) and is responsible for coordination, tracking, and management of logistics in support of clinical trials.
- Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects including review and approval of regulatory package for release of clinical supply.
- Reviews clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, timelines, etc.
- Responsible for set-up, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files. Coordinates TMF transfer with CROs.
- Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific study requests and issues.
- Works with CRO to collect and review essential regulatory documents prior to site initiation/study drug release.
- Assists CTM in review of study plans.
- Assists CTM in review and approval of informed consent templates.
- Participates in user acceptance testing (UAT) for EDC/IWRS.
- Manages and coordinates logistics for clinical and non-clinical supplies.
- Responsible for agendas and meeting minutes for clinical study team meetings.
- Manages logistics and assists with the coordination of investigator meetings, CRO kick-off meetings, and vendor meetings along with CTM and external meeting planners.
- Responsible for routing, tracking, and coordinating site and CRO/vendor Confidential Disclosure Agreements (CDAs), contracts and change orders with Associate Director Clinical Operations, legal, and finance departments.
- Assists with facilitating site advertisement review and approval.
- Responsible for special projects supporting operations/departmental initiatives such as ClinicalTrials.gov, SOPs, GCP, process enhancements, outsourcing, Sunshine Act, systems implementation, training, etc.
Education/Skills and Experience Requirements:
- Bachelor's degree or equivalent undergraduate degree with science or healthcare experience
- Experience: minimum 4 years clinical research experience in a pharmaceutical/biotech, CRO setting
- Solid knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
- Strong interpersonal, organizational, and multi-tasking skills
- Excellent attention to detail and problem solving skills
- Self-motivated and displays initiative
- Perform job duties with minimal supervision and guidance
- Ability to work effectively work in a team setting
If you or a Senior Clinical Trial Associate you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role.
Sthree US is acting as an Employment Business in relation to this vacancy.