Site Liaison/ Clinical Trials Coordinator
- Knoxville, TN, United States
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.
Friday, March 17, 2023