Associate Director, Contracts - National Center for Clinical Trials (NCCT)

Carolinas Medical Center

United States

Remote

USD 76,000 - 113,000

Full time

5 days ago
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Job summary

Carolinas Medical Center seeks an experienced leader to provide operational oversight for enterprise clinical trial contracting across advocate health and Wake Forest University School of Medicine. You will direct contract administration, supervise staff, and collaborate with stakeholders to accelerate study activation while ensuring compliance with regulations.

The role requires extensive knowledge of CTAs, CDAs, MCTAs, and related agreements, plus strong negotiation and reporting skills to

Qualifications

  • Bachelor's degree required; applicable professional certifications may be considered.
  • Minimum seven (7) years of experience in clinical research/contracting or related healthcare research.
  • Three (3) years of leadership or management experience overseeing staff.

Responsibilities

  • Lead enterprise clinical trial contracting activities for industry-sponsored research.
  • Direct contract administration team: coaching, performance management, workload allocation.
  • Oversee CTAs, CDAs, MCTAs, amendments, and related agreements, ensuring timely negotiation and execution.

Skills

Clinical research regulations
Contract negotiation
Stakeholder management
Project leadership
Analysis and reporting

Education

Bachelor's degree

Job description

Department

10010 NCCT (National Center for Clinical Trials) - Administration

Status

Full time

Benefits Eligible

Yes

Hours Per Week

40

Schedule Details/Additional Information

Remote
First Shift, Standard business hours, M-F

Pay Range

$54.90 - $82.35

Job Description Summary

Provides operational leadership and oversight for enterprise clinical trial contracting activities supporting industry-sponsored clinical research across Advocate Health and Wake Forest University School of Medicine. Responsible for directing contract administration operations, supervising contracting personnel, ensuring efficient negotiation and execution of clinical research agreements, monitoring performance metrics, implementing process improvements, and collaborating with stakeholders to accelerate study activation while maintaining compliance with institutional, regulatory, and legal requirements.

Major Responsibilities
  • Provides operational leadership and oversight for enterprise clinical research contracting activities supporting industry-sponsored clinical research, ensuring timely negotiation, execution, and administration of clinical research agreements.
  • Designs and directs the work of the clinical trial contracts team, including selection, coaching, development, performance management, and workload allocation for contract administration staff.
  • Oversees negotiation, review, execution, and management of Clinical Trial Agreements (CTAs), Confidential Disclosure Agreements (CDAs), Master Clinical Trial Agreements (MCTAs), amendments, and other research-related agreements.
  • Monitors contract performance metrics, turnaround times, service levels, and operational workloads; develops and implements strategies to improve efficiency, quality, and customer service.
  • Develops, implements, and maintains standardized contract templates, workflows, negotiation strategies, and best practices that enhance consistency and reduce study startup timelines.
  • Collaborates with investigators, research administration, legal counsel, finance, compliance, regulatory affairs, and operational stakeholders to facilitate study activation and resolve complex contractual issues.
  • Provides guidance and resolution for high-risk or complex contractual negotiations involving intellectual property, publication rights, indemnification, confidentiality, subject injury, data use, and related provisions.
  • Supports implementation, optimization, and utilization of research administration systems and technologies that facilitate contract management, reporting, and operational efficiency.
  • Prepares and presents operational reports, dashboards, and performance analyses to research administration leadership to support strategic planning and decision-making.
  • Responsible for understanding and adhering to the organization's Code of Ethical Conduct and ensuring that contracting activities and supervised employees comply with organizational policies, applicable regulations, and governing laws.
Education Required

Bachelor's degree required. In some circumstances, equivalent years of direct research administration experience or applicable professional certifications may be considered in lieu of a bachelor's degree.

Work Experience Required
  • Minimum seven (7) years of progressively responsible experience in clinical research, research administration, clinical trial contracting, grants and contracts administration, or related healthcare research environment.
  • Minimum three (3) years of leadership, supervisory, or management experience overseeing staff involved in research administration, contracting, or related operational functions.
Knowledge, Skills & Abilities Required
  • Knowledge of clinical research regulations, sponsor-funded research administration processes, and clinical trial agreement requirements.
  • Knowledge of Clinical Trial Agreements, Confidential Disclosure Agreements, Master Clinical Trial Agreements, amendments, and related research contracts.
  • Knowledge of contractual provisions including intellectual property, publication rights, confidentiality, subject injury, indemnification, insurance, and data use terms.
  • Strong contract negotiation, conflict resolution, and stakeholder management skills.
  • Ability to analyze complex contractual language and communicate business, legal, and operational impacts to diverse audiences.
  • Strong organizational, analytical, problem-solving, and decision-making skills.
  • Ability to manage multiple priorities and competing deadlines in a fast-paced environment.
  • Demonstrated leadership, coaching, mentoring, and personnel management abilities.
  • Strong oral, written, and presentation communication skills.
  • Proficiency with Microsoft Office applications and research administration technology platforms.
  • Ability to evaluate operational metrics and implement process improvements that enhance efficiency, quality, and service delivery.
Physical Requirements and Working Conditions

Work is performed primarily in a professional office or r

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