Medical Affairs Project Specialist

Kelly Science and Clinical FSP is currently seeking a Medical Affairs Study Coordinator for a long-term engagement in Jacksonville, FL with one of our Global clients. This position is remote with 10% travel. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

QUALIFICATIONS:

1. Minimum education required for competent performance:

• Bachelors in science or technical field, masters preferred

1. Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:

• 2-5 years experience in Research & Development
• Ophthalmology experience preferred
• Customer focused and confident, ability to build and maintain customer relationships (physicians, KOLs, CROs, etc.)
• Excellent scientific analytic skills desired
• Results and performance driven attitude desired
• Knowledge of Microsoft Office Suite including Word, PowerPoint, Excel

1. Equipment usage and abilities needed:

• Medical devices experience strongly preferred
• Understanding of regulations
• Multitasking and organization
• Strong Communication skills

1. Conditions & Physical Demands of Job

• Work is in a clean office or a clean clinical environment with interaction with various cross-functional partners (e.g. Marketing, R&D, etc.) and external stakeholders (e.g. surgeons, study staff, etc.)on a regular basis.
• Some domestic travel may be required 10-15%

SUPERVISION/AUTHORITY

1. Gives no supervision to others
2. Under general or minimum supervision, performs duties in terms of stated objectives. Generally works out details within broad guidelines and exercises considerable initiative and judgment.

JOB GOAL:

1. Perform various administrative functions as requested by Optometrist and clinical functions as approved by Medical Affairs. Adhere to all client and environmental policy, procedures, and supports department environmental objectives

RESPONSIBILITIES:

1. Tasks can be both clinical under the clearance of the Medical Affairs team and administrative.
2. Administrative tasks may include and are not limited to: tracking studies, writing reports and analyzing data.
3. Work with potential investigators and key opinion leaders to support the development of data and address evidence generation needs.
4. Clinical tasks may include assisting with clinical protocol review and/or development, clinical reports, developing test methods, and supporting evidence generation activities.
5. Under the clearance and oversight of a site's CRA and COM, contribute to site communications and site training activities.
6. Collaborate with study responsible Medical Affairs and other cross-functional teams.
7. Attend Global Research Review Committee meetings, represent all regional IIS study proposals, and present study proposals and provide input.
8. Potentially conduct site visits, attend relevant OD and/or MD conferences, and travel as required.
9. Perform other work as needed or required by the manager.