Job: Clinical Outreach Manager

The Clinical Outreach Manager is responsible for administration of project specific biobanking clinical research activities, management of the clinical data collection and monitoring process, and all associated project administrative tasks. Clinical familiarity within respective disease process to assist with writing protocols, developing data collection tools and adhering to regulatory requirements. Provides oversight and support to internal and external research and data coordinators in their function of regulatory approvals, patient enrollment and data collection activities. Coordinates project activities to ensure research compliance and timely collection of research data endpoints to achieve project milestones are met. Oversees assurance of adherence to SOPs, Good Clinical Practice and FDA regulations.
In addition to working closely with all IGC staff and other departments this position works closely with colleagues at other hospitals, universities, research entities and federal/state/philanthropic agencies to develop relationships to meet project goals.

1. Manage daily clinical operations of assigned project to ensure maintenance of data endpoints and project timelines are met in accordance with SOPs, GCP and Federal Regulations.
2. Conduct training during site education and monitoring visits at each research site and facilitate communication between internal and external project personnel to ensure efficient operations through a proactive team environment.
3. Assist Associate Director/Vice President as needed with preparation of new research protocols, data reports, protocol revisions, and all regulatory requirements for sponsor oversight of the conduct of clinical research.
4. Collaborate with IT Department to revise existing database systems or design appropriate automated mechanism to improve and enhance clinical reporting data capture systems.
5. Relies on extensive experience and clinical judgment to plan proactively for project deliverables.
6. Initiate, manage and/or provide support for all project specific administrative tasks related to assigned project. Such tasks include contract executions, budgetary development and oversight, regulatory approvals, and project report development.
Follows safety standards in all aspects of performance of the above functions, reports/removes unsafe equipment and attends safety education sessions.

This position requires a clinical background with a minimum of an Associate Degree in Nursing or related field and at least 5-7 years of clinical research background involving operational health care management experience with large, complex, interdisciplinary clinical project/programs. Regulatory knowledge of clinical research conduct, health care operations and biobanking is strongly preferred. Master’s degree in health care management or business is preferred. Candidate must possess technical, business, promotional and educational writing and presentation skills. Strong and demonstrable planning, management, organization, communication, collaborative and analytical skills are required. IGC employees are expected to adhere to service standards, code of conduct and organizational values in all their interactions with customers and fellow employees.