Under the general direction of the Director Clinical Research manages all the project management duties related to clinical trials and research regarding opening new trials or existing studies in progress. Includes interaction with clinical research sites and designated parties in management of all aspects of the development and management of clinical trials.
' ' Project Management Oversees all projects from concept development to study completion
Manages the Project Management team
- Develops trial concepts based on discussions with the PI and pharmaceutical company
- Assesses feasibility of investigator initiated concepts and protocols received from industry including presenting these concepts and protocols to RAB
- Establishes timelines for each trial based on the needs and expected performance of the ION-CR network
- Communicates with industry sponsors and ION-CR physicians in developing strategic trial concepts to maintain a full and scientifically sound trial pipeline.
Performs responsibilities of a Director Project Management
- Trains Project Managers on ION-CR processes
- Assigns projects to PM team members
- Oversees the writing of the protocol and ensures timelines are met based on ION-CR projected timelines
- Oversees PM Monthly reports
- Oversees relationship with CRO/Data Management company to ensure data timeliness CRF appropriateness
Regulatory Management Oversees the Regulatory Department
- Sets priorities for the Clinical Research Regulatory Specialist
- Establishes timelines for submission of protocols to IRB and FDA
- Establishes timelines for collection of appropriate regulatory documents per trial
- Manages regular meetings with PM team and CRRS to ensure all team members are aware of current priorities
- Schedules / manages meeting planning for ION-CR trial-related teleconferences with sponsors/CROs
- Oversees communication between PM team and CRRS with sites
- Collaborates with the Vice President Clinical Research in developing overall ION-CR trial pipeline Gantt charts and accrual projections on a quarterly basis and in preparation for estimating the annual budget projections.
- Collaborates on the development of streamlined processes/procedures for the development and operation of clinical trials.
- Interacts with the FDA when necessary to ensure that trial development is managed according to FDA guidelines. Oversee the submissions to the FDA as applicable (protocols IND exemption requests 1572 submissions SAEs etc.)
- Travel requirements: investigator meetings industry meetings ION meetings and ION-CR training courses as needed
- Attends study related teleconferences and meetings as required.
- Fosters collaborative working relationships with co-workers practices & physicians
- Abides by the Code of Federal Regulations referring to GCP and ICH guidelines at all times
- Performs related duties as assigned.
Requires some training in fields such as a medical specialty including nursing pharmacy or a specific discipline which is generally obtained through completion of a four year Bachelor's Degree program BA BS or minimum 6 years in clinical research or related field with demonstrated excellent organizational skills.' '
- Detail-oriented meticulous nature
- Self-motivated team-oriented
- Ability to work with minimal supervision & in a home office environment
- Committed to quality oncology care
- Experience with Good Clinical Practices and FDA regulations
- Good writing skills
- Excellent organizational & communication skills
- Strong interpersonal skills and ability to work with a multi-disciplinary team
- Ability to design forms and complete reports using computer software such as Microsoft WORD EXCEL internet email
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