Clinical Research Associate Manager---Cancer Center Protocol Office

GENERAL 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 project
• Facilitate new hire, correction action, and performance evaluation process for research staff
• Train new staff and assess continuing education need
• 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 studie
• Work with department heads to resolve procedural issues associated with clinical research workflows.
• Manage studies of a particular specialized program
• Disease specific administrative tasks

Management 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 tools

Clinic 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 procedure
• Coordinate patient appointments with physicians, nurses, and all test area
• Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to provider
• 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 sample
• 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 studie
• Administer quality of life assessments as required for individual studie

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 with the ability to resolve operational matters within a disease group
• Potential to effectively supervise and train staff

Qualifications

LICENSES, CERTIFICATIONS, and/or REGISTRATIONS:

• None

EDUCATION:

• BA/BS degree required

EXPERIENCE:

• 2-3 years research 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 will be performed in an office setting

EEO Statement

Massachusetts General Hospital is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.