Clinical Research Manager--Early Cancer Detection---Cancer Center Protocol Office
Massachusetts General Hospital(MGH)

GENERAL SUMMARY/OVERVIEW STATEMENT:

The Center for Innovation in Early Cancer Detection (CIECD) was established to increase the development of new cancer-detecting technologies. We are excited to launch a new clinical trial to advance this effort and we are looking for a Clinical Research Manager with project management experience to oversee the day-to-day operations of this trial. The Clinical Research Manager will be responsible for working with stakeholders to establish processes and manage the clinical trial to ensure all requirements are met. As the program expands, the Clinical Research Manager will be responsible for the recruitment, hiring and day-to-day management of the program's Clinical Research Associates and Clinical Research Coordinators. This position reports to the Senior Clinical Research Manager and will work closely with investigators and various leadership teams. The Clinical Research Manager works independently with general supervision. The Clinical Research Manager may maintain some data management responsibilities. The initial training will be in Boston, and the primary work location will be in MGH Waltham upon training completion. Though there may also be a future expectation to travel to other network sites collaborating on the project. The ideal candidate would possess the following 1) ability to handle heavy project management responsibility and ensure all necessary items are in place to move the project forward 2) enjoys hands-on work and able to do different things on different days, 3) has the flexibility to commute to multiple locations within the Greater Boston area, and 4) ability to train and manage a dynamic team over time.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Management responsibilities may include the following

• Provide first-line supervision to a minimum of 4-6 FTEs and/or assist with department-wide specialized projects
• Facilitate new hire, correction action, and performance evaluation process for research staff
• Train new staff and assess continuing education needs
• Assist staff with task prioritization for project assignments by meeting regularly and maintaining meeting documentation
• Manage staff productivity and quality of work produced by assessing work effort on individual studies.
• Identify changes associated with Standard Operating Procedures and develop processes to ensure compliance
• Oversee pre-activation activities
• Assist investigators with the completion of the New Protocol Intake Sheet for regulatory routing
• Coordinate and verify all new study activation requirements
• Proctor meetings, supply meeting materials and develop group-specific tools
• Establish and conduct departmental quality control measures

• Assist in the development and implementation of case report forms and other data management tools in conjunction with the Principal Investigators, database personnel, and other appropriate members of the research team
• Mentor study staff and may assist in orienting Associate Manager

Scientific Administrative Responsibilities as part of management team:

• Serves as the key point of contact between different groups by managing important relationships including but not limited to investigators, lab researchers, external collaborators/partners and various units/departments within the hospital.
• Support day-to-day operation of assigned projects
• May involve process improvement by modifying existing and creating new procedures
• Assist in preparing data for presentations and manuscripts
• Obtain metrics to measure project and team progress, ensure timeline is met
• Ensure timely follow up and track progress of related projects and program goals
• Organize meetings among collaborators, investigators, and laboratory researchers to ensure project-specific tasks are being executed
• Contribute to strategic planning and special project oversight as needed
• Generate meeting minutes and action items as needed

Data management responsibilities may consist of the following:

• Have comprehensive knowledge of all assigned protocols

• Develops protocol specific flow charts, intake sheets and other tools as needed to ensure protocol compliance and proper data acquisition

• May involve with verifying patient eligibility via chart abstraction, registering patients, collecting detailed clinical and treatment information
• Work closely with clinical and laboratory researchers to ensure samples are obtained, processed, shipped and received per protocol requirements.
• Implement and monitor procedures to ensure protocol compliance
• Manage data collection via chart abstraction and submit data in timely fashion
• Monitor and report adverse events as required by institutional/federal regulations
• Resolve data discrepancies
• Prepare IRB submission of protocol revisions, deviations, safety reports, annual progress reports
• Assess impact of new risk information on consent documents and revise appropriately
• Acquire specific knowledge of all relevant MGH, MGB and DF/HCC policies and procedures
• Organize and attend on- and off-site meetings to establish procedures
• Monitor affiliate site patient data; implement procedures to ensure compliance
• Interface in a professional manner with a diverse team of physicians, laboratory scientists, clinical research assistants, research nurses, pathologists, and potentially patients, involved in cutting-edge cancer research and drug development.

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

• Demonstrated time management and organization skills
• Strong written and verbal communication skills
• Knowledge of current and developing clinical research trends
• Sound interpersonal skills
• Ability to work independently and display initiative
• Demonstrated ability to successfully manage multiple projects
• Established rapport with investigators and sponsors with the ability to resolve operational matters within a disease group
• Ability to effectively supervise and train staff
• Proficient in Microsoft Office (Word, Excel, PowerPoint, OneDrive, SharePoint, Teams)

Qualifications
EDUCATION:

• BA/BS degree required

EXPERIENCE:

• 3-5 years research experience required
• Minimum of 1 year of management experience required
• Prior experience within the Cancer Center Protocol Office (CCPO) preferred

SUPERVISORY RESPONSIBILITY:

• Orient and train new staff and may supervise a minimum of 4-6 FTEs

WORKING CONDITIONS:

• Duties may be performed in a combination of on-site and remote work setting.

EEO Statement
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.

This job has expired.