Job Description:

The Manager, Research Early Phase Program serves as the operational clinical lead for the Early Phase Oncology Research Program. This role is responsible for identifying and tracking potential clinical trial participants, optimizing patient enrollment, maintaining program performance metrics, and leading quality and safety initiatives that support the successful execution of the Phase I Unit and other early phase oncology studies in a community oncology setting.

Working collaboratively with physicians, advanced practice providers, research nurses, clinical research coordinators, clinic leadership, and SOC staff, the Manager oversees patient screening workflows, monitors operational performance, coordinates multidisciplinary communication, and drives continuous process improvement. This position will serve as the primary clinical resource for early phase screening operations and program coordination. This position will also serve as a backup research nurse in the phase 1 unit for patient care and trial participation as needed.

ESSENTIAL FUNCTIONS:

Early Phase Program Leadership

• Serve DDU operational and clinical manager for patient screening within the Early Phase Research Program.
• Collaborate with physicians and research leadership to maximize enrollment opportunities across the early phase portfolio.
• Develop and standardize screening workflows to improve efficiency and consistency.
• Identify operational barriers and recommend process improvements to optimize clinic performance.
• Assist with implementation of new early phase protocols and program initiatives.
• Serve as a resource for research staff regarding available studies, eligibility criteria, and patient identification strategies.
• Acts as a liaison for screening, scheduling, and communication between MDs and other clinic research staff.
• Lead and develop employees by hiring, onboarding, coaching, mentoring, and providing ongoing performance feedback to build individual capability and team effectiveness.
• Manage employee performance by setting clear expectations, conducting performance evaluations, addressing performance concerns, recognizing achievements, and implementing development plans as needed.
• Promote employee engagement and accountability by fostering a positive, inclusive, and respectful work environment that encourages collaboration, open communication, and high performance.
• Ensure compliance with company policies and employment practices by consistently applying organizational policies, supporting workplace safety, and partnering with Human Resources on employee relations matters, including corrective action and conflict resolution.
• Plan and manage team resources by assigning work, setting priorities, monitoring productivity, approving time off and schedules, and ensuring appropriate staffing levels to meet business objectives.

Patient Screening & Trial Identification

• Review clinic schedules, pathology reports, genomic testing, laboratory results, imaging, and medical records to proactively identify potential trial candidates.
• Evaluate patient documents for protocol-specific inclusion and exclusion criteria.
• Maintain active screening logs and patient tracking databases.
• Monitor patient treatment progress and anticipate future trial opportunities.
• Communicate potential research opportunities with investigators prior to clinic visits.
• Coordinate with referring physicians and multidisciplinary teams regarding potential research candidates.
• Maintain awareness of all active and upcoming early phase clinical trials.

Program Metrics & Performance Management

• Develop, maintain, and analyze operational dashboards, records, and key performance indicators for the Early Phase Program.
• Track and report metrics including:
  • Patient screening volume
  • Enrollment and accrual rates
  • Screen failures
  • Physician-specific enrollment
  • Trial-specific enrollment

Safety & Quality Leadership

• Organize and facilitate weekly Early Phase Program Safety Meetings. and Slot Review Meeting
• Organize and coordinate monthly Phase 1 Clinical operations meeting
• Prepare meeting agendas, quality reports, protocol deviation summaries, and safety metrics.
• Track action items and ensure timely completion.
• Collaborate with investigators and leadership to address operational and patient safety concerns.
• Promote adherence to Good Clinical Practice (GCP), institutional policies, sponsor requirements, and regulatory standards.

Collaboration & Communication

• Facilitate communication related to patient eligibility, enrollment planning, and study prioritization.
• Participate in multidisciplinary meetings, investigator meetings, and strategic planning sessions.

Quality Improvement & Program Development

• Identify opportunities to improve patient identification and enrollment processes.
• Participate in strategic planning initiatives to expand the Early Phase Research Program.
• Assist in developing standard operating procedures (SOPs), workflows, and educational materials.
• Support accreditation, sponsor audits, and internal quality initiatives.
• Promote a culture of collaboration, accountability, and continuous improvement.

KNOWLEDGE, SKILLS & ABILITIES:

• Clinical Leadership
• Operational Excellence
• Oncology Clinical Research
• Early Phase Trial Knowledge
• Patient Screening & Enrollment
• Data Analysis & Reporting
• Quality Improvement
• Project Management
• Relationship Building
• Critical Thinking
• Problem Solving
• Effective Communication
• Organization & Time Management

EDUCATION & EXPERIENCE:

• Current Registered Nurse (RN) license.
• Associate in nursing or Bachelor of Science in Nursing (BSN) preferred.
• 5+ years of experience as a registered nurse
• 3+ years of oncology nursing experience.
• Previous clinical research experience required.
• Strong knowledge of oncology clinical trial conduct, protocol interpretation, and Good Clinical Practice (GCP).
• Excellent organizational, communication, analytical, and project management skills.
• Proficiency with electronic medical records, Microsoft Office Suite, and data reporting tools.

Preferred

• Two years of oncology clinical research experience.
• Previous supervisory and/or management experience
• Early Phase (Phase I) oncology research experience.
• Experience with molecular profiling and precision oncology.
• Experience developing dashboards and operational metrics.
• Experience leading multidisciplinary quality improvement initiatives.

OOCUPATIONAL RISK CATEGORY:

PHYSICAL REQUIREMENTS:

Job Title:

Physical Activity Required

Amount of time

None

Less than 1/3
(Occasionally)

1/3 to 2/3
(Frequently)

More than 2/3
(Regularly)

Standing

X

Walking

X

Sitting

X

Fingering or manual dexterity

X

Repetitive finger motion

X

Lifting or exerting force

X

Up to 10 pounds

X

Up to 25 pounds

X

Up to 50 pounds

X

Up to 100 pounds

X

Over 100 pounds

X

Reaching or stretching

X

Climbing or balancing

X

Crouching or stooping

X

Speaking

X

Hearing

X

Seeing (with correction)

X