DUTIES AND RESPONSIBILITIES:

• Works with Regional Medical Directors to establish new physician relationships, serving as the primary team member to coordinate and drive research activity.
• Maintains extensive contact with the Sites, including regular Site visits, surveys to elicit feedback from the Site Directors and their teams, etc.
• Serves as the Sponsor contact for study status, accrual challenges, etc.
• Works with the Sponsors to ensure constructive feedback is being provided to the Sites from the Sponsor organizations.
• Ensures Site issues are timely addressed with the Sponsors.
• Works with Site to determine Study feasibility
• Submits protocol and safety reports to Central IRB.
• Serves a resource for Site regarding safety reporting requirements.
• Serves as a resource for GCP training.
• Tracks all study metrics and drives Site to meet timelines for start-up, accrual, and protocol or budget amendments.
• Works closely with Site Liaison Director and other team members to promote cohesive operations.

EDUCATION, TRAINING AND EXEPERIENCE

• Healthcare-related Bachelor of Science degree or equivalent clinical trial experience.
• Minimum of 5 years clinical research experience.
• Site management experience preferred.
• Liaison and/or marketing experience preferred.
• Experience in contracting and negotiating clinical trial agreements preferred.
• Experience in conducting Study feasibilities preferred.
• Experience in IRB submissions preferred.
• Experience in clinical trial billing and accounting preferred.
• Research certification preferred.

REQUIRED KNOWLEDGE, SKILLS and ABILITIES

• Must be knowledgeable in regulatory and operational aspects of conducting clinical trials.
• Must be knowledgeable in ICH/GCP and regulatory requirements of the FDA.
• Must be knowledgeable in the conduct of Study feasibilities.
• Must be knowledgeable in IRB submissions.
• Must have excellent organizational and time-management skills.
• Must have exceptional communication skills in both verbal and written form.
• Must be able to prioritize and coordinate multiple tasks.
• Must be able to promote a positive customer service image and maintain positive working relationships with internal and external customers.
• Must be able to work effectively will all personality types while maintaining a knowledgeable, positive image of the company initiatives.
• Working knowledge of Microsoft Office products is sufficient to create reports, develop trackers, prepare presentations and create professional documents.
• Ability to sit, stand, walk, reach, climb or balance, stoop or crouch, hand/wrist use, talk, see, and hear for extended periods of time.
• Ability to lift up to 50 pounds.
• Travel required: approximately 5 days overnight per month. Travel can be more or less depending on business requirements.