Clinical Trial Specialist

HOW WILL YOU MAKE A DIFFERENCE?

You will initiate and provide oversight for a multicenter medical device registries and provide support to clinical trials and investigator-initiated research projects. You will also support the process of obtaining clinical data for publications of peer-reviewed manuscripts.

WHAT WILL YOUR DUTIES AND RESPONSIBILITIES BE?

• Responsible for comprehensive clinical and post-marketing tasks, consisting of but not limited to:
• Provide broad support for multicenter US clinical studies including data management, site visits, document control, regulatory submissions, and site correspondence.
• Contribute to development of key study documents including, but not limited to, study protocols and protocol synopses, protocol amendments, study plans and procedure manuals, project tools, informed consent forms, clinical study reports, and study newsletters.
• Work with trial managers to develop SOPs and supporting documents to submit to internal and external regulatory bodies (ie., IRB, FDA) to ensure trials are consistent with approved protocols.
• Work closely with CROs, consultants, and vendors to coordinate or perform a wide variety of administrative and data management activities for clinical trial functions and project goals.
• Work with investigative sites to ensure subject safety in all areas of clinical research and following procedures to report SAEs and UADEs to clinical and regulatory management.
• Develop project-tracking systems and action plans and provide accurate progress reports on assigned studies and sites.
• Ensure compliance with all applicable local, state, and federal regulations, statutes, and laws, and with agencies including the IRB and Federal Drug Administration (FDA). Maintain compliance with Good Clinical Practice (GCP) guidelines, patient confidentiality (HIPAA) and any other applicable laws.
• Oversee CRF and database development process, accurate and timely quality data collection.
• Review and develop appropriate budgets, negotiate contracts and prepare agreements for the conduct of clinical trials at investigative centers.
  
  

Team: Fostering a Healthy, Enjoyable, and Engaged Workplace Environment:

• Contribute to a positive and collaborative team culture by promoting open communication, respect, and mutual support.
• Actively participate in team meetings, share knowledge, and best practices to enhance overall team performance.
• Seek opportunities to celebrate team successes and foster a sense of camaraderie.
• Collaborate with colleagues across departments, fostering cross-functional teamwork and synergy.
• Provide constructive feedback and support to team members, promoting personal and professional growth.
• Embrace and promote a healthy work-life balance, ensuring personal well-being and encouraging others to do the same.
  
  

Relationship Building:

• Foster strong relationships with key stakeholders, including surgeons, perfusionists, nurses, and research staff.
  
  

Travel:

• Domestic travel required (~25%, dependent on trial activity).
• Some international travel may be required.
  
  

Requirements:

WHAT SKILLS AND EXPERIENCE WILL YOU NEED?

• Bachelor’s Degree in a medical or scientific discipline preferred
• 3+ years’ relevant clinical research experience in medical device (strong preference for registry or real-world evidence preferred)
• Demonstrated knowledge of FDA regulations, ICH – GCP guidelines and ISO 14155
• Excellent communication and writing skills required to work effectively with all individuals and to develop SOPs
• Proficient computer skills using Microsoft Office products as well as CRM, Quality Management Systems, and experience with Electronic Medical Records (EMR) and Data Capture Forms/Case Report Forms (DCFs/CRFs)
• Able to adapt and execute should strategic goals shift during the life of the project
• Must work both independently and in a team environment
• Good command of the English language, spoken and written
  
  

WHAT SKILLS WOULD BE HELPFUL?

• Certification through a professional organization such as ACRP, SOCRA, or RAPS
• Proficiency with 21 CFR 812, 21 CFR 814, and 21 CFR 820
• Management of contracts, budget negotiations and site payments
• Understanding of anatomy, physiology, and medical terminology
• Ability to proactively drive projects and be persistent in follow-up for tasks required to achieve management timelines
• Ability to handle new challenges and solve unexpected problems
• Ability to effectively manage a study from start to finish
  
  

Compensation and Benefits:

• Salary Range: $75,000 - $105,000
• Other Compensation: All Employee Bonus Program
• Company Benefits include paid Medical, Dental, Vision, Short Term Disability, Long Term Disability, and Life insurance
• Sick leave and Flexible Time Off
• 401K Match
• Paid Maternity, Paternity, and Adoption Leave AND
• Well-Being Benefit