Clinical Research Manager - Genitourinary Oncology

Dana-Farber Cancer Institute; Boston (MA); Hybrid; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Clinical Research Manager to lead the Genitourinary Oncology clinical research program. This hybrid role involves overseeing clinical trials, ensuring compliance with regulatory standards, and managing a dedicated research team. The ideal candidate will have a strong background in clinical trials management, regulatory compliance, and staff supervision. Join a forward-thinking organization committed to groundbreaking cancer research and patient care, where your contributions will directly impact the lives of patients and advance innovative treatment solutions. If you are passionate about making a difference in the field of oncology, this opportunity is perfect for you.

Qualifications

• Minimum 5 years of related experience preferred.
• Ability to function independently with previous supervisory experience.

Responsibilities

• Oversee clinical trial portfolio and ensure regulatory compliance.
• Manage recruitment, training, and performance evaluations of research staff.

Skills

Regulatory Compliance

Clinical Trials Management

Data Management

Supervisory Skills

Interpersonal Skills

Organizational Skills

Communication Skills

Microsoft Office

EPIC

Oncore

Education

Bachelor's Degree

Tools

Livelink

Oncore

EPIC

Job description

Overview

The Clinical Research Manager (CRM) will work within the Genitourinary Oncology (GU) clinical research program and manage the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Trials Office. The Clinical Research Manager, in collaboration with the program's physicians and research nursing staff, is responsible for the design, implementation, and evaluation of their program's clinical research activities (therapeutic and non-therapeutic), all related regulatory and compliance oversight, and direct supervision of their program's clinical research staff. The Clinical Research Manager is responsible for tracking and complying with clinical trial performance benchmarks; e.g. protocol and regulatory compliance, patient safety, staff development & training, and financial goals, as defined by Senior Research Leadership and the DFCI Clinical Trials Office.

This role is a hybrid position requiring 2-3 days onsite per week. The selected candidate may only reside & work remotely within the New England states (ME, VT, NH, MA, CT, RI).

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life-changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds and design programs to promote public health, particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Responsibilities

Clinical Trials Operations

1. Clinical Research Managers (CRM) are responsible for the oversight of their disease group's clinical trial portfolio and all related regulatory, compliance, and performance metrics requirements.
2. The CRM will oversee the processing of protocols through DFCI Institutional Review Board (and other institutions' IRBs) when appropriate.
3. The CRM will collaborate with the DFCI Clinical Trials Office (CTO), the Office for Human Research Studies (OHRS), and the Office of Data Quality (ODQ) to fulfill local and federal requirements governing human clinical trials.
4. The CRM will identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and act as a leader in overseeing their resolution.
5. The CRM will assist the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds.
6. Oversees and coordinates the purchase, receipt, inventory, and distribution of equipment utilized in the conduct of clinical trials.
7. In collaboration with clinical research administration and grant managers, may maintain, monitor, and reconcile all study and related grant finances. These may include budget development, expenditure tracking, procurement, salary offset worksheets, and staffing.
8. Assists the principal investigator in preparing manuscripts for publication.
9. The CRM will collaborate with the DFCI CTO and DF/HCC ODQ to develop study forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials.
10. The CRM will oversee the subject enrollment, protocol treatment, and follow-up care processes for protocol patients.
11. Oversees registration of protocol patients with ODQ or OnCore policies and pharmaceutical company as outlined in protocol.

Regulatory & Compliance

1. Assumes responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance.
2. Assumes responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations, etc. Implements systems to monitor portfolio compliance.
3. Responsible for the disease group's transition from paper to electronic regulatory binders. Will maintain per DFCI CTO standards.

Data Management & Clinical Trial Monitoring

1. Assumes responsibilities for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for timely and complete data collection.
2. Regularly reports data compliance status to key stakeholders; i.e. DFCI PI, study Sponsor, DFCI CTO. Implements corrective action to maintain data compliance when necessary.
3. Submits required "progress / tracking" reports to key stakeholders when applicable.

Staff Hiring, Supervision, Training & Development

1. Responsible for the recruitment and oversight of all of the research staff. Ensure that all staff complete required mandatory and ongoing training in a timely manner. Develops and oversees a program-specific onboarding and orientation process and conducts annual performance evaluations and competency assessments of research staff.
2. Develops a standard supervision schedule with research staff including periodic individual and group supervision meetings. Will develop an agenda, take attendance, and document all applicable meetings.
3. Will communicate all personnel concerns to their immediate supervisor and to DFCI HR partner for the appropriate response and follow-up.

Qualifications

1. Bachelor's Degree required, with a minimum of 5 years of related experience preferred.
2. Must have the ability to function independently and must have previous supervisory experience.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

1. Must be able to perform day-to-day responsibilities independently with minimal supervision from manager.
2. Must be somewhat proficient in the following; identifying complex regulatory scenarios that require consultation, clinical trials start-up, active and close-out phases, clinical research local policy, and federal regulation.
3. Must have some proficiency to manage personnel issues and to provide critical feedback to supervisees when applicable.
4. Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
5. Experience in protocol development, data compilation, and analysis.
6. Skilled at developing tracking systems to ensure timely data management by the clinical research staff.
7. Expert knowledge of Federal and State regulations as they relate to research. Strong interpersonal, organizational, and communication skills are required.
8. Must have computer skills including the use of Microsoft Office and working knowledge of Livelink; EPIC and Oncore applications.

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.

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