Clinical Research Contract Specialist

Description

DermCare is seeking a Clinical Research Contract Specialist. Clinical Research Contract Specialist will report to the VP of Research and will play a critical role in supporting successful partnerships with clinical trial sponsors and our network of investigators. The role requires strong communication and organizational skills, along with a deep understanding of the clinical trial process. The Clinical Research Contract Specialist will work closely with sponsors, investigators, and internal teams to negotiate fees and reimbursements. The primary responsibility will be to support facilitating the smooth and compliant execution of clinical trial contracts, ensuring alignment with both sponsor and practice needs.

Responsibilities:

• Contract Negotiation Support:

• Engage with sponsors and their legal teams to negotiate clinical trial fees, reimbursements, and other financial terms.
• Collaborate with investigators and clinical research teams to understand the specific needs and requirements of each trial.
• Ensure all agreements comply with federal, state, and local regulations, as well as DermCare Management’s internal policies.

• Contract Management:

• Draft, review, and revise clinical trial agreements.
• Track and manage the contract lifecycle from initial negotiations through final execution.
• Maintain accurate and up-to-date records of all contractual documents and communications.

• Stakeholder Communication:

• Serve as the point of contact between sponsors, investigators, and internal teams for all research contract-related matters.
• Provide regular updates to stakeholders on the status of contract negotiations and ensure timely resolution of any issues.

• Compliance and Risk Management:

• Support VP of Research and legal counsel to address complex contract terms and ensure DermCare Management's interests are protected.
• Advise internal teams on compliance with relevant regulations and guidelines.

• Financial Coordination:

• Support VP of Research and finance department in ensuring proper budget alignment and fiscal account set-up for each trial.
• Monitor payment schedules and ensure timely reimbursements from sponsors.

Qualifications

Qualifications:

• Preferred bachelor’s degree in business administration, legal studies, Healthcare Administration, or a related field. Equivalent experience may be considered in lieu of a degree.
• Minimum of 3 years of experience in contract negotiation, preferably within clinical research or healthcare settings.

Skills:

• Must have strong negotiation and communication skills with the ability to interact effectively with both internal and external stakeholders.
• Excellent organizational skills with keen attention to detail.
• Proficiency in Microsoft Office and contract management software.
• Ability to manage multiple contracts and projects simultaneously.

Knowledge:

• Familiarity with clinical trial processes, FDA regulations, and industry standards is preferred.
• Understanding of financial terms and budgeting in the context of clinical trials.