These job descriptions are examples. Looking for work?

Find JobsFind Jobs

ISS Medical Education Specialist

0 people like this description

Responsible for all administrative aspects of investigational studies (investigator sponsored studies (ISS) and company sponsored studies) and medical education (MedEd) grants. This includes accurate and timely maintenance of all study information in multiple clinical trial databases and grants information in MedEd grant database. Interfaces regularly with MA Operations, MSLs and investigator sites concerning investigational study status/medical education grants and resolution of administrative issues. Maintains all study and grant tracking activities, prepares and reports all metrics data.

Major tasks and responsibilities of position
- Oversees and manages all ISS data per SOP in multiple specialized databases (IMPACT, dBox and STREAM) including study site information, patient accruals, payment milestones, and study medication shipments.
- Collaborates with MSLs and Medical Experts as appropriate. Coordinates activities with MSLs to ensure timely activation and follow-up on status of new and on-going studies.
- Receives ISS submission from on-line system, reviews for accuracy, and communicates with MSL to ensure completeness for review. Prepares grant agreement templates and initial packages for study sites. Frontline interface with investigator sites to track research grant agreement status, site activation, study progress and to process milestone payments and study medication shipment requests.
- Liaises with Regulatory and Legal Departments as appropriate to obtain required documentation for study approval.
- Responsible study medication distribution, tracking and supply forecasting.
- Liaise with CRO(s) concerning all company sponsored studies. Prepares Phase IV study meeting agenda, conducts meetings, documents and distributes minutes as necessary.
- Manages MedEd grant database. Assist with processing and tracking grant payments in assigned TA, as well as development and distribution of MedEd grant meeting agenda and minutes.
- Generates ad hoc ISS and MedEd grants reports and provides study file materials upon request.
- Provides support for monthly accruals and financial updates; prepares and reports on ISS and MedEd metrics.
- Additional projects and/or responsibilities as needed.

These job descriptions are examples. Looking for work?

Find JobsFind Jobs