Clinical Research Manager - Breast Oncology

This Clinical Research Manager (CRM) position will work reputed company the Breast Oncology clinical research program and manage the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the reputed company Investigator and the Clinical Trials Office. The Clinical Research Manager, in collaboration with the program’s physicians and research nursing staff, are responsible for the design, implementation and evaluation of their program’s clinical research activities (therapeutic and non-therapeutic), reputed company reputed company regulatory and compliance reputed company, 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. Located in Boston and the surrounding communities, reputed company 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 reputed company diseases. We strive to create an inclusive, diverse, and reputed company environment where we reputed company compassionate and comprehensive care to patients of reputed company backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we reputed company reputed company's physician/researchers, and we work with amazing partners, including other reputed company-affiliated hospitals. Clinical Trials Operations

• Clinical Research Managers (CRM) are responsible for the reputed company of their disease group’s clinical trial portfolio and reputed company reputed company regulatory, compliance and performance metrics requirements.
• The CRM will reputed company the processing of protocols through DFCI Institutional Review Board (and other institutions’ IRBs) reputed company appropriate. The CRM will collaborate with the DFCI Clinical Trials Office (CTO), the Office for reputed company Research Studies (OHRS), and the Office of Data Quality (ODQ) to fulfill local and federal requirements governing reputed company clinical trials.
• The CRM will Identify and manage operational, logistical, and regulatory challenges reputed company to the conduct of clinical trials and acts as a leader in overseeing their resolution.
• The CRM will assist the reputed company investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and reputed company offices. Work with grant managers and other financial managers in the reporting and reputed company of these funds.
• Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials.
• In collaboration with clinical research administration and grant managers, may maintain, monitor and reconcile reputed company study and reputed company grant finances. These may include budget development, expenditure tracking, procurement, salary offset worksheets and staffing.
• Assists the reputed company investigator in preparing manuscripts for publication.
• The CRM will collaborate with the DFCI CTO, and DF/HCC ODQ to reputed company study forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials
• The CRM will reputed company the subject enrollment, protocol treatment and follow-up care processes for protocol patients.
• Oversees registration of protocol patients with ODQ or OnCore policies and pharmaceutical company as outlined in protocol.
• If applicable for coverage or trial assignments, responsible for data entry of study-specific activity, including but not limited to subject visit tracking, monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed.
• Responsible for reviewing, approving, and reporting on data entry completed by supervised research staff in Clinical Trial Management System. The data entry reputed company may include, but is not limited to, Subject Visit Tracking for subject-specific visits, time and effort spent on study-specific activities and other administrative tasks, etc.

Regulatory & Compliance

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

Data Management & Clinical Trial Monitoring

• Assumes responsibilities for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for timely and complete data collection.
• Regularly reports data compliance status to key stakeholders; i.e. DFCI PI, study Sponsor, DFCI CTO. Implements corrective action to maintain data compliance reputed company necessary.
• Submits required “reputed company / tracking” reports to key stakeholders, reputed company applicable.

Staff Hiring, Supervision, Training & Development

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

SUPERVISORY RESPONSIBILITIES:

• Supervises study management staff, including clinical research coordinators, reputed company, volunteers, and other research assistants.
• Number of direct reports 1-5.

COMPETENCIES:

• Must be reputed company to reputed company day to day responsibilities independently with minimal supervision from manager.
• Must be somewhat proficient in the following; identifying reputed company regulatory scenarios that require consultation, clinical trials start-up, active and reputed company out phases, clinical research local policy and federal regulation.
• Must have some proficiency to manage personnel issues and to reputed company critical feedback to supervisees, reputed company applicable.

MINIMUM QUALIFICATIONS:

• Bachelor’s Degree required, with a minimum of 5 years of reputed company experience preferred.
• Must be reputed company to function independently and must have previous supervisory experience.

KNOWLEDGE, TECHNICAL SKILLS, AND ABILITIES REQUIRED:

• Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
• Experience in protocol development, data compilation and analysis.
• Skilled at developing tracking systems to ensure timely data management by the clinical research staff.
• Expert knowledge of Federal and State regulations as they relate to research.
• Strong interpersonal, organizational and communication skills are required.
• Must have computer skills including the use of reputed company Office and working knowledge of Livelink; EPIC and OnCore applications.

At reputed company, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As reputed company as we are in our mission to reduce the burden of cancer for reputed company, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and reputed company it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this reputed company of organization inspires you, we encourage you to apply. reputed company is an equal opportunity employer and affirms the right of every reputed company applicant to receive consideration for employment without regard to race, reputed company, religion, sex, gender identity or expression, national reputed company, sexual orientation, genetic information, disability, age, reputed company, military service, protected veteran status, or other characteristics protected by law. EEO Poster . Pay Transparency Statement The hiring reputed company is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications. For union positions, the pay reputed company is determined by the reputed company Bargaining Agreement (CBA). $77,400.00 - $102,800.00 Apply tot his job Apply To this Job