- 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
- 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
- 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
- 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
- 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
- BA/BS degree required
- Minimum 2 years research experience required, 3 years research preferred.
- Prior experience within the Cancer Center Protocol Office (CCPO) preferred
- Orient and train new staff and may supervise a minimum of 4-6 FTEs
- Duties will be performed in a hybrid setting
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Software Engineer Cancer Center Protocol Office
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Partners Healthcare System Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Coordinator. The Cancer Center Protocol Office is a centralized clinical research office that supports clinical resea ...
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Massachusetts General Hospital Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking a motivated, detail-oriented individual to join our team as a Clinical Research Coordinator. The Cancer Center Protocol Office is a centralized research office that supports clinical researchers i ...
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Partners Healthcare System Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Associate. The Cancer Center Protocol Office is a centralized research office that supports clinical researchers in a ...
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Partners Healthcare System Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Coordinator. The Cancer Center Protocol Office is a centralized clinical research office that supports clinical resea ...
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Partners Healthcare System Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Coordinator. The Cancer Center Protocol Office is a centralized clinical research office that supports clinical resea ...
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Massachusetts General Hospital Boston, United StatesThe Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Coordinator. The Cancer Center Protocol Office is a centralized clinical research office that supports clinical researchers in Clinical Research, Research C ...
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Partners Healthcare System Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Pappas Center for Neuro-Oncology at Massachusetts General Hospital is seeking a motivated, conscientious individual to join our team as a Clinical Research Coordinator (CRC). The CRC will work under general supervision of and report to t ...
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Massachusetts General Hospital Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Associate/Clinical Research Coordinator. The Cancer Center Protocol Office is a centralized research office that supp ...
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Massachusetts General Hospital Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking motivated, detail-oriented individual to join our team as a Clinical Research Biopsy Coordinator. The Cancer Center Protocol Office is a centralized clinical research office that supports clinical ...
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Massachusetts General Hospital Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Data Specialist (CRDS). The Cancer Center Protocol Office is a centralized research office that supports clinical res ...
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Massachusetts General Hospital(MGH) Boston, United StatesGENERAL 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 th ...
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Clinical Research Coordinator II
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Clinical Research Coordinator
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Clinical Research Coordinator
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Per Diem Research Assistant
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Partners Healthcare System Boston, United StatesThe Clinical Research Coordinator I (CRC) for the Orthopaedic Spine Service will be responsible for assisting with the day-to-day clinical research operation. She/he will be responsible for IRB protocol development, candidate screening, clinical evaluation, coordination of patien ...
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Clinical Research Coordinator
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Beth Israel Lahey Health Boston, United StatesJob Type: Regular · Time Type: Full time · Work Shift: Day (United States of America) · FLSA Status: Non-Exempt · When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Responsible for screening research subjects for par ...
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Brigham and Women's Hospital Boston, United StatesThe Clinical Research Coordinator II works within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DF/HCC Clinical Trials Office and/or Pa ...
Clinical Research Associate Manager---Cancer Center Protocol Office - Boston, United States - Partners Healthcare System
Description
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:
Management responsibilities may include the following:
Data management responsibilities may consist of the following:
Clinical responsibilities may consist of the following:
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
EDUCATION:
EXPERIENCE:
SUPERVISORY RESPONSIBILITY:
WORKING CONDITIONS:
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