Clinical Research Director

OneOncology•Charlotte, NC

1d•Onsite

About The Position

Carolina Oncology Specialists is seeking a Clinical Research Director to provide strategic leadership, operational oversight, and drive the growth of its clinical research program. This role is crucial for ensuring all oncology clinical trials are conducted in compliance with ICH-GCP guidelines, regulatory requirements, and organizational policies. The Director will be responsible for advancing the site’s research capabilities, improving patient access to innovative therapies, leading the research team, managing study portfolios, fostering relationships with sponsors and CROs, and ensuring high-quality, efficient study execution. The ideal candidate will be an experienced oncology research professional with strong leadership, regulatory expertise, and operational management skills.

Requirements

Extensive knowledge of ICH-GCP, FDA regulations, and clinical trial compliance requirements.
Strong understanding of oncology clinical trials, including treatment modalities and safety reporting (CTCAE, RECIST).
Proven leadership and team management skills with the ability to develop and motivate staff.
Expertise in clinical trial operations, study lifecycle management, and regulatory processes.
Ability to analyze data, manage budgets, and make strategic decisions.
Excellent organizational, problem-solving, and project management skills.
Strong communication and interpersonal skills with the ability to collaborate with internal and external stakeholders.
Ability to manage multiple priorities in a fast-paced clinical environment.
High level of attention to detail and commitment to patient safety and data integrity.
Bachelor’s degree in life sciences, healthcare, nursing, or related field required.
Minimum of 5–7 years of clinical research experience, with at least 3 years in a leadership or management role.
Extensive experience in oncology clinical research strongly preferred.
Experience managing multi-study portfolios and research teams.

Nice To Haves

Master’s degree (MBA, MPH, or similar) preferred.
Certification (CCRC, CCRP, or equivalent) preferred.
Experience with sponsor/CRO partnerships, budgets, and contract negotiations strongly preferred.

Responsibilities

Provides strategic direction and oversight for all clinical research operations, including study start-up, enrollment, conduct, and close-out.
Leads and manages the clinical research team, including Clinical Research Coordinators, regulatory staff, and research support personnel.
Develops and implements departmental goals, KPIs, and growth strategies to expand oncology clinical trial offerings.
Oversees study feasibility assessments, site selection, and study activation processes.
Ensures compliance with ICH-GCP, FDA regulations, IRB requirements, and institutional policies across all studies.
Maintains accountability for the quality and integrity of clinical trial data and patient safety.
Oversees regulatory operations, including IRB submissions, amendments, continuing reviews, and audit readiness.
Ensures successful execution of sponsor monitoring visits, audits, and regulatory inspections.
Establishes and maintains strong relationships with sponsors, CROs, investigators, and research partners.
Monitors study enrollment, timelines, and financial performance, ensuring targets are met.
Collaborates with finance and leadership on study budgets, contract negotiations, and resource allocation.
Oversees adverse event reporting, protocol deviations, and compliance-related issues.
Develops and implements SOPs, policies, and process improvements for research operations.
Supports physician investigators in research engagement, protocol development, and study execution.
Provides staff training, mentorship, and performance management to ensure high-functioning teams.
Ensures effective communication across departments, including infusion, lab, pharmacy, and administrative teams.
Identifies opportunities to expand research services, partnerships, and trial access for patients.
Represents the organization in external research initiatives, sponsor meetings, and industry collaborations.
Promotes a culture of quality, compliance, and continuous improvement within the research department.