Clinical Outreach Manager

JOB SUMMARY: 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 SOP’s, Good Clinical Practice and FDA regulations. 

In addition to working closely with all IGC staff and other departments within the Molecular Profiling Institute (MPI) this position works closely with colleagues at other hospitals, universities, research entities and federal/state/philanthropic agencies to develop relationships to meet project goals. 

ESSENTIAL FUNCTIONS: 

1.

Manage daily clinical operations of assigned project to ensure maintenance of data endpoints and project timelines are met in accordance with SOP’s, GCP and Federal Regulations. 

2.

Conduct training during semiannual 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.

PHYSICAL/MENTAL DEMANDS/ ENVIRONMENT:
This position requires travel including automobile and air; long periods of sitting, bending, standing, and use of a computer, telephone, varied office machines; and, the ability to lift and carry up to 25 pounds of material, supplies, and/or equipment.

EQUIPMENT USED:
Standard office equipment including telephone, personal computer, printers, fax, calculator, audio-visual equipment, and copy machines. Networked computer system including research management application systems and shared file directory.

MARGINAL/ADDITIONAL FUNCTIONS:
Performs other duties as directed by supervisor related to research conduct and operations or the leadership of IGC.


SUPERVISORY RESPONSIBILITIES:

 

Directly Reporting:

 

Cancer Tumor Registrars

Clinical Data Coordinators

 

Indirectly Reporting:

 

External Research Coordinators assigned to project area

 

Scope of Supervisory Responsibilities:

 

Supervisory responsibilities include: candidate selection (hire/fire), training & development, performance appraisals, work assignments, disciplinary action, and PTO oversight

IGC Leadership will strive to uphold the mission, vision, and values of the organization. They will serve as role models for staff and act in a people-centered, service excellence-focused, and results-oriented manner.

SCOPE AND COMPLEXITY:
This position has responsibility within the assigned project area and their related entities, with frequent internal contact with IGC Leadership and interdisciplinary staff.  External contacts with funding entities, regulatory authorities, local, state, and national investigators.  Current requirements include presentations to professional and lay person organizations with interstate and international scientific collaborations likely. Makes or endorses recommendations and advises senior leadership. Recommendation and advice could have substantial influence within the assigned project area for the organizations research project initiatives. Requires extensive amount of initiative, analytical and evaluation efforts and constructive thinking to develop alternatives for resolution to frequently changing situations and difficult problems.

This position is complex in the balancing of expectations of the project area, research investigators, hospital staff, and sponsors in managing the growth of services given budgeting and staffing challenges. This position is pivotal for the compliance and execution of biobanking research protocols and clinical data collection while maintaining a positive work environment and accomplishing integration of organizations strategic plans. 


MINIMUM QUALIFICATIONS:
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.