Clinical Trial Associate
Responsible for oversight of vendors/consultants, which includes communicating timelines, negotiating contracts, preparing purchase requisitions, and coordinating related activities.
Assist in the development, maintenance, training, and record keeping Clinical SOPs and guidelines in accordance with GCP, ICH, and FDA Guidelines.
Actively participate in design, development, and review of study protocols, reports, and case report forms to ensure compliance with GCP, ICH, and FDA guidelines.
Provide management support for activities with outside vendors and business partners, as required.
Support preparation activities for FDA and other applicable regulatory body meetings
Travel may be required (up to 30% of the time) based on department needs
Reports study metrics and other critical information to project management using study trackers, data forms, and report
Assists Clinical Project Manager (CPM) with the tracking and review of safety events
Assists in the development of critical study documents, including clinical protocols, ICFs, operational documents, study reference documents, study newsletters, site materials, and other study-related documents
Provides vendor management support to CPM
Assists data management, CPM, and monitors by driving site data entry and query resolution
High energy individual able to effectively multi-task, priority set, and strive in a dynamic environment.
Excellent communication (oral and written), organizational, and problem-solving skills.
Able to quickly grasp concepts and instructions
Individual will possess attention to detail, requiring little revision to work produced
Overall understanding of early to late stage clinical trial process
Strong attention to detail
Prior experience in monitoring clinical trials and data.
At HumanEdge, we create great hiring experiences for candidates and clients alike. We do it by applying our skills, energy, integrity and understanding of both individual needs and market forces to make the right match for all types of positions, including traditional contract assignments, career-changing direct searches, and freelance gigs. We know that you're more than a skill set and cluster of job experiences -- you're a whole person with big dreams and ambitions. When you work with us, you partner with a firm committed to helping drive your success with ongoing support, guidance, and tangible opportunities. For over 30 years we've helped candidates like you make the right move in a wide array of industries and variety of positions