Manager Clinical Research - TMC Oncology

SUMMARY:

The Clinical Research Manager oversees the daily clinical activities for specified research trials, ensuring adherence to protocols, regulatory guidelines, and ethical standards set by the Principal Investigator (PI) and sponsoring organizations. They promote good clinical practices by possessing in-depth knowledge of federal regulations and guidance documents governing clinical trials and human subject protection. The Clinical Research Manager conducts clinical tasks per protocol, collects and maintains data and source documentation, and assures compliance with protocol and regulatory requirements. They collaborate closely with PIs, department members, study sponsors, and institutions to support the administration of compliance, financial, personnel, and other aspects of ongoing clinical studies.

The Clinical Research Manager is responsible for managing a team of employees, providing guidance, monitoring performance, and ensuring maximum productivity and compliance. Their main goal is to lead and develop their team, communicate departmental goals, and provide constant feedback and support.

ESSENTIAL FUNCTIONS:

Manages Clinical Research Coordinators, Clinical Research Assistants, and Volunteers.

Perform management functions, including preparing work schedules, staff assignments, performance evaluations, and recommendations for personnel actions; distribute work evenly, monitor productivity and quality, provide immediate feedback, implement performance improvement plans, and administer disciplinary action under the Director's guidance.

Oversee documentation and credentialing for all departmental staff, including initiation and renewal notices, maintenance of records (CVs, GCP, COI, Financial Disclosures, Human Subject Research, and other required certifications).

Serve as a liaison and maintain communication with study monitors, Institutional Review Board (IRB), appropriate campus offices, and affiliated hospitals.

Manages daily operations, optimize efficient workflows, ensure staff compliance with policies and procedures, implement goals and objectives, and monitor work activities for compliance.

Maintain department records, reports, and files as required.

Lead research billing, regulatory, and research training compliance efforts.

Organize and prioritize workload, ensuring orderly and timely workflow.

Demonstrate initiative, resourcefulness, and problem-solving skills in applying detailed knowledge of departmental responsibilities, functions, and underlying management structure.

Assist the Director in addressing employee concerns/complaints and resolving problems jointly.

Manage departmental processes, including prioritizing, scheduling, reviewing work, prepping, assigning tasks, educating staff, quality assurance, productivity monitoring, research documentation, medical records, research billing, regulatory compliance, and auditing.

Onboard and conduct all department-specific training.

Monitor, audit, and provide reports on employee quality and productivity.

Lead in preparing and organizing monitoring visits and site initiation visits, ensuring action items are closed out from each visit.

Assist in testing, implementing, training, and documenting policies, procedures, processes, and standard work.

Handle all calls and walk-ins. Supports Research Visits and ensures Participant Experience Surveys are completed.

Coordinate ongoing office projects such as digitizing records, website maintenance, and other assigned projects.

Develop and manage the participant recruitment plan and lead recruitment events. Reports recruitment and enrollment metrics to investigators on a weekly basis.

Coordinate educational and departmental activities, and provide administrative support, including educational coordination for investigators.

Ensure departmental goals, deadlines, and performance standards are met.

Train and onboard new hires, ensuring they understand their roles and comply with departmental metrics.

Maintain, complete, and submit reports and records as required by policy, federal, state, and local regulations.

Adheres to organizational and department-specific safety standards and guidelines.

Adheres to TMCH values of integrity, diversity, accountability, compassion, and teamwork.

Perform related duties as assigned.

MINIMUM QUALIFICATIONS

EDUCATION:

EXPEREINCE:  Bachelor's degree in a field appropriate to the area of assignment and six (6) years related research experience; OR a master’s degree with five (4) years research experience appropriate to the area of assignment.

LICENSURE OR CERTIFICATION:  Accredited Clinical Research Professional or LPN licensure permitting work in the State of Arizona preferred.

KNOWLEDGE, SKILLS, AND ABILITIES: 

• In-depth knowledge of federal regulations (FDA, ICH-GCP, etc.) and guidance governing clinical trials and human subject protection.
• Knowledge of clinical research protocols, processes, and documentation requirements.
• Knowledge of data management principles and electronic data capture systems.
• Understanding of clinical research billing compliance.
• Knowledge of recruitment strategies and participant retention methods.
• Strong organizational and project coordination skills.
• Proficiency with Microsoft Office suite and clinical research software/databases.
• Attention to detail and ability to follow protocols with accuracy.
• Effective communication skills, both written and verbal.
• Analytical and problem-solving skills.
• Training and mentoring abilities.
• Ability to prioritize and multi-task in a fast-paced environment.
• Ability to work independently and collaboratively in a team setting.
• Ability to interpret and apply complex regulations and guidelines.
• Ability to maintain confidentiality of research data and participant information.
• Ability to build rapport and maintain professional interactions.
• Ability to exercise sound judgment and make decisions.
• Ability to follow through initiatives, tasks, deadlines, and projects.
• Ability to adapt to change and implement new processes.