Director of Clinical Trials

Arizona Center for Cancer Care•Scottsdale, AZ

2h•Onsite

About The Position

The Director of Clinical Trials provides strategic, operational, and financial leadership for the Arizona Center for Cancer Care clinical research program. This role oversees all phases of clinical trial operations with a strong emphasis on clinical trial contracting, budgeting, sponsor negotiations, and regulatory compliance. The Director serves as a key liaison between investigators, sponsors, CROs, legal, finance, compliance, and operational teams to ensure timely study activation, financial integrity, and sustainable growth of the oncology clinical trials portfolio.

Requirements

Bachelor’s degree required, master’s degree in clinical research, healthcare administration, business administration, public health, or a related field preferred
Minimum of seven (7+) years of experience in clinical research operations, including clinical trial agreement and budget negotiation
Ability to demonstrate experience managing financial, contractual, and regulatory requirements within clinical research
Ability to demonstrate experience working within a healthcare system, physician practice, or research network preferred

Nice To Haves

Good Clinical Practice (GCP) certification preferred or ability to obtain within thirty (30) days of hire
Clinical research certification (CCRP, CCRC, or equivalent) preferred

Responsibilities

Leads and reviews the negotiation of clinical trial agreements (CTAs), budgets, payment terms, and contract amendments
Reviews and approves clinical trial budgets to ensure accurate cost recovery, appropriate margins, and billing compliance
Ensures compliance with Medicare Clinical Trial Policy (NCD 310.1), including oversight of coverage analysis and delineation of standard-of-care versus research-billable services
Partners with legal, compliance, and finance teams to ensure contracts align with organizational risk tolerance and regulatory requirements
Reviews contract execution timelines to support efficient study start-up and activation
Oversees and reviews sponsor payments, invoicing, and financial reconciliation across active trials
Leads the development and implementation of strategic direction for the oncology clinical trials program
Reviews study feasibility and financial viability in collaboration with Principal Investigators and leadership
Ensures appropriate oversight of investigator-initiated trials, cooperative group or NCI-sponsored studies, and expanded access or compassionate use protocols
Leads and reviews the establishment and maintenance of standard operating procedures related to contracting, budgeting, study activation, and trial execution
Provides oversight and review of clinical trial operations from start-up through close-out
Ensures compliance with GCP, FDA regulations, IRB requirements, sponsor protocols, and institutional policies
Reviews oncology-specific operational requirements, including protocol-driven diagnostics, biomarker testing, and molecular profiling
Partners with pharmacy, pathology, imaging, infusion services, and ancillary clinical teams to ensure protocol feasibility and compliant investigational product handling
Ensures audit readiness and serves as a leader during sponsor audits and regulatory inspections
Identifies operational, regulatory, and financial risks and ensures appropriate mitigation strategies are implemented
Leads, reviews, and supports clinical research management, contracting, and research operations staff
Establishes and reviews key performance metrics, including study start-up timelines, budget negotiation cycle times, enrollment performance, and financial outcomes
Serves as a primary point of contact for sponsors and CROs regarding contract, budget, and study activation matters
Builds and maintains relationships with investigators to support trial participation and alignment with operational and financial goals
Represents Arizona Center for Cancer Care in sponsor meetings, feasibility discussions, investigator meetings, and industry forums