Clinical Research Associate/Coordinator I
MGB Anesthesiology, Boston, MA, United States
Job Summary
The Clinical Research Associate/Clinical Research Coordinator I (CRA/CRC I) works under general supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. It will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The candidate will be trained on institutional and federal regulations governing clinical research. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination, with direct patient contact.
Principal Duties and Responsibilities
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 studies
Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria
Enroll patients as required by the study sponsor and internal enrollment monitor team
Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance
Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements
Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations
Maintain research charts and/or electronic files for all enrolled patients
Ensure adequate source documentation is in place for all data reported
Resolve data queries issued by the sponsor
Obtain protocol clarifications from the study sponsor and communicate information to the research team
Schedule and prepare for monitoring visits with sponsors
Facilitate the request and shipment of archival pathology samples
Organize and prepare for internal and external audits
Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies
Maintain and organize study specific regulatory binders
Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB
Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study
Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required
Submit Data and Safety Monitoring Reports
Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process
Collect, complete, and submit essential regulatory documents to various regulatory entities
Participate in monitoring visits and file all monitoring visit correspondence
Ensure appropriate documentation of delegation and training for all study staff members
Maintain screening and enrollment logs
Essential Functions
Coordinate patient appointments with physicians, nurses, and all test areas.
Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition.
Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all criteria.
Enroll patients as required by the study sponsor and internal enrollment monitor team.
Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance.
Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.
Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations.
Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study.
Collect, complete, and submit essential regulatory documents to various regulatory entities.
Qualifications
Education: Bachelor's Degree in a related field of study required.
Experience: Clinical research or compliance experience 1-2 years preferred.
Knowledge, skills and abilities: Ability to work independently and as a team member; analytical skills and ability to resolve problems; ability to interpret acceptability of data results; careful attention to detail; good organizational and communication skills; working knowledge of clinical research protocols.
No experience in lieu of a degree is accepted.
Physical Requirements
Standing Frequently (34-66%)
Walking Frequently (34-66%)
Sitting Occasionally (3-33%)
Lifting Frequently (34-66%) 35lbs+ (w/assisted device)
Carrying Frequently (34-66%) 20lbs - 35lbsPushing Occasionally (3-33%)
Pulling Occasionally (3-33%)
Climbing Rarely (Less than 2%)
Balancing Frequently (34-66%)
Stooping Occasionally (3-33%)
Kneeling Occasionally (3-33%)
Crouching Occasionally (3-33%)
Crawling Rarely (Less than 2%)
Reaching Frequently (34-66%)
Gross Manipulation (Handling) Frequently (34-66%)
Fine Manipulation (Fingering) Frequently (34-66%)
Feeling Constantly (67-100%)
Foot Use Rarely (Less than 2%)
Vision – Far Constantly (67-100%)
Vision – Near Constantly (67-100%)
Talking Constantly (67-100%)
Hearing Constantly (67-100%)
Remote Work Location and Compensation
Location: 125 Nashua Street, Hybrid work schedule, scheduled weekly hours 40. Employee type: Regular. Work shift: Day (United States of America). Pay range: $20.16 – $29.01 per hour. Grade: 5.
EEO Statement
Equal Opportunity Employer . The General Hospital Corporation is an Equal Opportunity Employer. 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. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.
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The Clinical Research Associate/Clinical Research Coordinator I (CRA/CRC I) works under general supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. It will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The candidate will be trained on institutional and federal regulations governing clinical research. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination, with direct patient contact.
Principal Duties and Responsibilities
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 studies
Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria
Enroll patients as required by the study sponsor and internal enrollment monitor team
Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance
Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements
Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations
Maintain research charts and/or electronic files for all enrolled patients
Ensure adequate source documentation is in place for all data reported
Resolve data queries issued by the sponsor
Obtain protocol clarifications from the study sponsor and communicate information to the research team
Schedule and prepare for monitoring visits with sponsors
Facilitate the request and shipment of archival pathology samples
Organize and prepare for internal and external audits
Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies
Maintain and organize study specific regulatory binders
Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB
Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study
Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required
Submit Data and Safety Monitoring Reports
Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process
Collect, complete, and submit essential regulatory documents to various regulatory entities
Participate in monitoring visits and file all monitoring visit correspondence
Ensure appropriate documentation of delegation and training for all study staff members
Maintain screening and enrollment logs
Essential Functions
Coordinate patient appointments with physicians, nurses, and all test areas.
Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition.
Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all criteria.
Enroll patients as required by the study sponsor and internal enrollment monitor team.
Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance.
Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.
Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations.
Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study.
Collect, complete, and submit essential regulatory documents to various regulatory entities.
Qualifications
Education: Bachelor's Degree in a related field of study required.
Experience: Clinical research or compliance experience 1-2 years preferred.
Knowledge, skills and abilities: Ability to work independently and as a team member; analytical skills and ability to resolve problems; ability to interpret acceptability of data results; careful attention to detail; good organizational and communication skills; working knowledge of clinical research protocols.
No experience in lieu of a degree is accepted.
Physical Requirements
Standing Frequently (34-66%)
Walking Frequently (34-66%)
Sitting Occasionally (3-33%)
Lifting Frequently (34-66%) 35lbs+ (w/assisted device)
Carrying Frequently (34-66%) 20lbs - 35lbsPushing Occasionally (3-33%)
Pulling Occasionally (3-33%)
Climbing Rarely (Less than 2%)
Balancing Frequently (34-66%)
Stooping Occasionally (3-33%)
Kneeling Occasionally (3-33%)
Crouching Occasionally (3-33%)
Crawling Rarely (Less than 2%)
Reaching Frequently (34-66%)
Gross Manipulation (Handling) Frequently (34-66%)
Fine Manipulation (Fingering) Frequently (34-66%)
Feeling Constantly (67-100%)
Foot Use Rarely (Less than 2%)
Vision – Far Constantly (67-100%)
Vision – Near Constantly (67-100%)
Talking Constantly (67-100%)
Hearing Constantly (67-100%)
Remote Work Location and Compensation
Location: 125 Nashua Street, Hybrid work schedule, scheduled weekly hours 40. Employee type: Regular. Work shift: Day (United States of America). Pay range: $20.16 – $29.01 per hour. Grade: 5.
EEO Statement
Equal Opportunity Employer . The General Hospital Corporation is an Equal Opportunity Employer. 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. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.
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