Job Details

Associate Clinical Research Contracts Specialist

SUMMARY OF THE JOB

Under direct supervision, performs the execution of contracting processes to ensure agreements are requested, executed, and maintained in compliance with internal processes and regulatory expectations.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Initiate agreement requests per company SOPs and legal requirements.
• Manage the end-to-end contracting process for agreements including, but not limited to, NDA, consulting, and vendor agreements.
• Serve as the primary point of contact between Clinical Research, Legal, HCC/Compliance, Privacy, and external parties
• Track agreement status, approvals, and execution timelines to ensure alignment with study milestones
• Ensure all agreements are fully executed prior to engagement or information exchange
• Maintain accurate and audit ready records of executed agreements and related documentation
• Support fair market value (FMV) confirmation and documentation, as applicable
• Communicate agreement status and timelines to study teams and stakeholders
• Participate in inspection readiness activities by providing agreement documentation as requested
• Actively participate in study team meetings and project updates.
• May assist in processing consulting/HCP payments
• May participate in process improvement activities within the department.
• May perform other related duties assigned as needed.
• Responsible for communicating business-related issues or opportunities to next management level.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:

• Bachelor's Degree or higher with 2-4 years of work-related experience
• Prefer a degree in the sciences
• Prefer knowledge of clinical research
• Prefer medical device experience in the cardiovascular field

REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:

• Ability to use PC and associated software.
• Excellent PowerPoint, Word, Excel skills.
• Excellent written and oral communications skills.
• Ability to multi-task, excellent attention to detail, and organizational skills.
• Working knowledge of Good Clinical Practices (GCP) is desirable.
• Knowledge of project management tools is desirable.