Clinical Research Associate---Cancer Center Protocol Office
Found in: Talent US C2 - 3 weeks ago
Description
GENERAL 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 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 Clinical Research Associate I (CRA I) works under general supervision to enroll eligible patients to clinical research protocols and manage data collection and regulatory submissions for multiple cancer studies. The CRA I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA I will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
The CRA I will perform the following data management duties under general supervision by the Clinical Research Manager:
· 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
The following regulatory duties may be performed under general supervision by the Clinical Research Manager:
· 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
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
· Careful attention to detail
· Good organizational skills
· Ability to follow directions
· Good communication skills
· Computer literacy
· Working knowledge of clinical research protocols
· Ability to demonstrate respect and professionalism for subjects rights and individual needs
Qualifications
EDUCATION:
BA/BS degree requiredEXPERIENCE:
NoneSUPERVISORY RESPONSIBILITY:
NoneWORKING CONDITIONS:
Duties may be performed in a combination of on-site and remote work setting
Primary Location
:MA-Boston-MGH Main Campus
Work Locations
:MGH Main Campus55 Fruit StreetBoston02114
Job
:Clinical
Organization
:Massachusetts General Hospital(MGH)
Schedule
:Full-timeStandard Hours:40
Shift
:Day Job
Employee Status
:RegularRecruiting Department:MGH Cancer Ctr - Protocol
Job Posting
:Feb 26, 2024-
Boston, United States Massachusetts General Hospital Full timeGENERAL 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 all disciplines within the Cancer Center. Our office promotes and facilitates...
-
Boston, United States Massachusetts General Hospital Full timeGENERAL 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 supports clinical researchers in all disciplines within the Cancer Center. Our office...
-
Boston, United States Partners Healthcare System Full timeGENERAL 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 researchers in all disciplines within the Cancer Center. Our office promotes and...
-
Boston, United States Massachusetts General Hospital Full timeGENERAL 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 researchers in all disciplines within the Cancer Center. Our office promotes and...
-
Boston, United States Massachusetts General Hospital Full timeGENERAL 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 researchers in all disciplines within the Cancer Center. Our office promotes and...
-
CLINICAL RESEARCH COORDINATOR---CANCER CENTER PROTOCOL OFFICE
Found in: Careerbuilder One Red US C2 - 4 days ago
Boston, MA 02298, USA, United States Massachusetts General Hospital Full timeGENERAL 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 researchers in all disciplines within the Cancer Center. Our office promotes and...
-
Assistant/associate Editor
4 days ago
Boston, United States American Association for Cancer Research Full timeOverview: **About **_Cancer Research Communications_**: Launched in 2021, _Cancer Research Communications_ is the AACR’s open access journal and the newest member of the AACR journal ecosystem, publishing high-quality original research articles that report information of value to the cancer research community in a timely and rigorous fashion. The...
-
Boston, United States Massachusetts General Hospital Full timeGENERAL SUMMARY/ OVERVIEW STATEMENT: The Clinical Research Assistant works under general supervision to perform administrative and clinical support for multiple clinical trials. PRINCIPAL DUTIES AND RESPONSIBILITIES: The following job duties will be performed under supervision by the Program Manager: * Assists Clinical Research Coordinators with...
-
Clinical Research Assistant--Cancer Center Protocol Office
Found in: beBee jobs US - 1 week ago
Boston, Massachusetts, United States Massachusetts General Hospital Full timeGENERAL SUMMARY/ OVERVIEW STATEMENT:The Clinical Research Assistant works under general supervision to perform administrative and clinical support for multiple clinical trials.PRINCIPAL DUTIES AND RESPONSIBILITIES:The following job duties will be performed under supervision by the Program Manager:Assists Clinical Research Coordinators with performing EKGs...
-
Clinical Research Assistant--Cancer Center Protocol Office
Found in: beBee S US - 7 days ago
Boston, United States Massachusetts General Hospital Full timeGENERAL SUMMARY/ OVERVIEW STATEMENT:The Clinical Research Assistant works under general supervision to perform administrative and clinical support for multiple clinical trials.PRINCIPAL DUTIES AND RESPONSIBILITIES:The following job duties will be performed under supervision by the Program Manager: Assists Clinical Research Coordinators with performing EKGs...
-
Assistant/Associate Editor
Found in: Resume Library US A2 - 4 days ago
Boston, Massachusetts, United States American Association for Cancer Research Full timeOverview: About Cancer Research Communications: Launched in 2021, Cancer Research Communications is the AACR’s open access journal and the newest member of the AACR journal ecosystem, publishing high-quality original research articles that report information of value to the cancer research community in a timely and rigorous fashion. The journal’s scope...
-
Clinical Research Assistant, Cancer Center
Found in: Talent US C2 - 2 weeks ago
Boston, United States Mass General Brigham Full timeClinical Research Assistant, Cancer Center -(3284862) Description GENERAL SUMMARY/ OVERVIEW STATEMENT:Summarize the nature and level of work performed. The MGH Sample Processing Laboratory (SPL) provides services involved in preparing research samples obtained from patients enrolled in clinical trials of investigational cancer treatments for storage...
-
Clinical Research Assistant, Cancer Center
3 days ago
Boston, United States Partners Healthcare System Full timeGENERAL SUMMARY/ OVERVIEW STATEMENT: Summarize the nature and level of work performed. The MGH Sample Processing Laboratory (SPL) provides services involved in preparing research samples obtained from patients enrolled in clinical trials of investigational cancer treatments for storage and shipment. The primary role of this position is to transport samples...
-
Clinical Research Coordinator I
3 weeks ago
Boston, United States DM Clinical Research Full timeJob DescriptionJob DescriptionClinical Research Coordinator IThe CRC I will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds...
-
Clinical Research Coordinator I
Found in: Resume Library US A2 - 2 weeks ago
Boston, Massachusetts, United States Joslin Diabetes Center Full timeOverview: The Clinical Research Coordinator I performs activities related to coordination and implementation of research protocols within the Beetham Eye Institute and Eye Research Section (both clinical trial and non-trial research). The Clinical Research Coordinator I is responsible for ensuring quality adherence to protocol-specific and general...
-
Research Technician
5 days ago
Boston, United States Dana-Farber Cancer Institute Full time**Job ID**: 39542 **Location**: 450 Brookline Ave, Boston, MA 02215 **Category**: Research Laboratory **Employment Type**: Full time **Work Location**: **Onsite**: 100% onsite Overview The Center for Early Detection and Interception of Blood Cancers is the first-of-its-kind clinic for patients with precursor conditions of hematologic malignancies. As...
-
Research Assistant
3 days ago
Boston, United States Dana-Farber Cancer Institute Full timeOverview The research assistant for REACH PC--a clinical trial that compares early in-person palliative care with telemedicine palliative care for metastatic lung cancer patients--has a critically important role in operationalizing this study and is the key to successfully adhering to the strict guidelines in the protocol. The person who will be selected...
-
Research Assistant
Found in: Talent US C2 - 2 weeks ago
Boston, United States Dana-Farber Cancer Institute Full timeOverview The research assistant for REACH PC--a clinical trial that compares early in-person palliative care with telemedicine palliative care for metastatic lung cancer patients--has a critically important role in operationalizing this study and is the key to successfully adhering to the strict guidelines in the protocol.The person who will be...
-
Director Scientific Research, Cancer Center
Found in: Talent US C2 - 2 weeks ago
Boston, United States Massachusetts General Hospital Full timeDirector Scientific Research, Cancer Center-(3285679) Description GENERAL SUMMARY/ OVERVIEW STATEMENT: The Cellular Immunotherapy Program at Massachusetts General Hospital is seeking a Director of Scientific Research to work in the Maus Lab. The Director of Scientific Research plays a key role in the day-to-day administration of the research...
-
RESEARCH LABORATORY TECHNICIAN, CANCER CENTER
Found in: Careerbuilder One Red US C2 - 4 days ago
Boston, MA 02129, USA, United States Massachusetts General Hospital Full timeGENERAL SUMMARY/ OVERVIEW STATEMENT:The Hata Lab in the Massachusetts General Hospital Cancer Center is seeking a highly motivated individual with a strong scientific background for a full-time laboratory research technician position. Research within the Hata Lab focuses on discovering mechanisms of drug resistance in lung cancer patients treated with...