Clinical Research Associate Manager-Cancer Center Protocol Office

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Cancer Center Protocol Office is seeking a Clinical Research Associate Manager to join our team. The Cancer Center Protocol Office is a centralized clinical research office that supports clinical researchers in all disciplines within the Cancer Center. Our office promotes and facilitates clinical research by providing comprehensive services to physicians conducting clinical trials while ensuring compliance with all regulatory requirements.

The Associate Manager works under direct supervision of a more experienced manager. The Associate Manager provides first-line supervision to research staff members and oversees the day-to-day operations of the staff while maintaining some data management responsibilities and a working knowledge of all aspects of clinical research data management.

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 specialized management projects of equivalent responsibility.

• 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 sponsors to resolve monitoring issues

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 pre-site qualification visits, SIVs, and facility tours

• Assist investigators with the completion of the New Protocol Intake Sheet for regulatory routing

• Proctor meetings, supply meeting materials and develop group-specific tools

Data management responsibilities may consist of the following:

• Verify patient eligibility via chart abstraction and analysis of case data

• Collect and interpret data necessary for enrollment; register patients

• 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, safety reports, annual progress reports

• Assess impact of new risk information on consent documents and revise appropriately

• Organize and attend on- and off-site Investigator meetings to establish procedures

• Organize and prepare for monitoring visits and both internal/external audits

• Design, create, and/or maintain databases (e.g. REDCap) of collected samples as needed

• Extract patient information and clinical data via EPIC medical chart review

Clinical responsibilities may consist of the following:

• Assist clinical team in identifying potential patients for study participation and ensure eligibility is met

• Schedule all protocol required tests and procedures

• Coordinate patient appointments with physicians, nurses, and all test areas

• Maintain and oversee a library of biospecimens obtained from patients in the clinic

• Organize blood sample collection from patients in the clinic (with phlebotomy responsibility)

• Obtain vital signs as required for individual studies

• Verify eligibility and consent patients to research studies

• 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

• Collect and interpret data necessary for patient enrollment and registration

• 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)

• May involve sample processing and banking

• Administer quality of life assessments as required for individual studies

• Attend research and disease group team meetings

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
• Potential to effectively supervise and train staff
• Ability to identify problems and develop solutions

EDUCATION:

• BA/BS degree required

EXPERIENCE:

• Minimum 2 years research experience required, 3 years research preferred.
• 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 a hybrid setting