Clinical Research Associate Manager---Cancer Center Protocol Office

2 weeks ago


Boston MA, United States Mass General Brigham Full time

DescriptionGENERAL SUMMARY/ OVERVIEW STATEMENT:The Clinical Research Associate Manager works under direct supervision of a more experienced manager. The Clinical Research Associate Manager provides first-line supervision to Clinical Research Coordinators (CRC) and oversees the day-to-day operations of the staff while maintaining some CRC responsibilities and a working knowledge of all aspects of research management in the clinic setting.  PRINCIPAL DUTIES AND RESPONSIBILITIES:Management responsibilities will 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·       Work with department heads to resolve procedural issues associated with clinical research workflows.  ·       Manage studies of a particular specialized program·       Disease specific administrative tasksManagement responsibilities may include the following:·       Work with the Clinical Research Manager or Director to identify changes associated with Standard Operating Procedures and develop processes to ensure compliance·       Assist with pre-activation activities including completing complexity ratings, completing CRC activation checklists, develop flow charts, and ensuring all protocol requirements are clinically feasible.  ·       Proctor meetings, supply meeting materials and develop group-specific toolsClinic management responsibilities may consist of the following:·       Implement and monitor procedures to ensure protocol compliance·       Assist clinical team in screening potential patients for study participation·       Schedule all protocol required tests and procedures·       Coordinate patient appointments with physicians, nurses, and all test areas·       Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providers·       Prepare pre-visit communication for providers to ensure required assessments are completed and documented·       Maintain point of contact communication with enrolled patients and assist with front line questions regarding study participation·       Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition·       Coordinate, obtain, process, and ship protocol required tissue samples·       Ensure collection and processing (e.g. spin/separate/freeze) of all required correlative research blood samples with the coordination of the MGH Sample Processing Lab (SPL)·       Obtain vital signs and perform EKGs as required for individual studies·       Administer quality of life assessments as required for individual studiesSKILLS/ ABILITIES/ COMPETENCIES REQUIRED:Demonstrated time management and organization skillsStrong written and verbal communication skillsKnowledge of current and developing clinical research trendsSound interpersonal skills Ability to work independently and display initiativeDemonstrated ability to successfully manage multiple projects Established rapport with investigators with the ability to resolve operational matters within a disease groupPotential to effectively supervise and train staffQualificationsEDUCATION:BA/BS degree requiredEXPERIENCE: 2-3 years research experience requiredPrior experience within the Cancer Center Protocol Office (CCPO) preferredSUPERVISORY RESPONSIBILITY:Orient and train new staff and may supervise a minimum of 4-6 FTEs WORKING CONDITIONS:Duties will be performed in an office settingJob Field: Research-ManagementOrganization: Massachusetts General Hospital(MGH)Schedule: Full-timeShift: Day JobEmployee Status: Regular



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