Promote good clinical practices in the conduct of clinical investigations by possessing an in-depth knowledge of federal regulations and K2 Medical Research guidelines (SOPs) for the enrollment and maintenance of subjects in clinical trials, and by collecting, recording, and maintaining source and sponsor documentation. Job DescriptionJob Description
At K2 Medical Research, we are transforming healthcare by delivering tomorrowās treatments today.
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Department OverviewIntegrated Healthcare: NENA comprises a collaborative team of 28 physicians and advanced practice clinicians, integrated within our health system, which includes over 700 affiliated doctors and a clinical partnership with a prominent medical center. About Us
Our organization is a leading integrated health system that combines the strengths of academic and community healthcare to provide exceptional, connected, and accessible care experiences across Massachusetts.
Boston, Massachusetts30+ days ago
Candidates must have at minimum a Bachelorās degree in a health or science related field, minimum one year of clinical research experience or relevant direct industry experience (e.g., CRC), ability to travel nationwide, must be detail-oriented, strong time management, and communication skills. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
p>Applicants with experience in any of the below indications will be considered: ā¢ Monitoring as a CRA or working as a study coordinator or clinician ā¢ Solid Tumor Breast/Ovarian/Prostate/Colorectal/Bladder/Lung/Kidney/Pancreatic Cancer ā¢ Small Cell Lung Cancer ā¢ Graft vs Host Disease ā¢ Glioblastoma ā¢ Melanoma ā¢ Leukemia ā¢ Lymphoma ā¢ Mesothelioma.
Named a Top Workplace in 2024 by The Cincinnati Enquirer Recognized by Forbes as one of Americas Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.
li>Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information) and regulatory requirements.
The CRA works closely with Lead CRAs, Sr CRAs, Clinical Trial Coordinators, Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work, Alira Health SOPs and regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.
Boston, Massachusetts17 days ago
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 perform the following data management duties under general supervision by the Clinical Research Manager: Ā· Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria.
p>The CRA I will perform the following data management duties under general supervision by the Clinical Research Manager:
Partner with Clinical Trial Managers and CRO monitoring teams to provide sponsor oversight and ensure monitoring activities align with the study's risk-based monitoring strategy. Building on prior experience in a Clinical Trial Assistant (CTA) or similar role, the CRA II independently manages assigned sites and supports study oversight of clinical trial execution.
li>Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
Boston, Massachusetts30+ days ago
In-house CRAs work closely with field CRAs and Clinical Project Managers to ensure the integrity of the trial data without the need for frequent travel. Ensures all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conducts routine file reviews.
Boston, Massachusetts30+ days ago
In-house CRAs work closely with field CRAs and Clinical Project Managers to ensure the integrity of the trial data without the need for frequent travel. Ensures all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conducts routine file reviews.
p>Responsibilities for the Oncology Clinical Research Associate: ā¢ Conduct site and study visits and perform all site monitoring activities across multiple study ā¢ Responsible for both remote and on-site monitoring and study activation ā¢ Participate in the development of study tools, protocols, and clinical trial documentation ā¢ Some travel required once travel bands are lifted.
Qualifications for the Oncology Clinical Research Associate:
ā¢ 3+ years of Oncology on-site Monitoring and hands on experience with EDC Systems ā¢ Experience with Phase 1 Oncology is non-negotiable ā¢ Organization to perform monitoring duties across multiple sites is a must.
Work in partnership with and/or escalate to the SCP to ensure quality of site deliveryInterface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sitesPartner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risksAttend investigator meeting when required (virtual or F2F). CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.
Cambridge, MA30+ days ago
li>Independently manage assigned investigative sites, including academic medical centers with limited IND experience, providing operational guidance to ensure protocol compliance, data quality, and effective management of high-volume clinical data. Demonstrated experience in independently managing investigative sites and conducting site qualification, initiation, routine monitoring (on-site and remote), and closeout visits, while ensuring compliance with ICH-GCP, regulatory requirements, and study protocols.
p>With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The Senior Clinical Research Associate will report to the VP Scientific and Medical Affairs and will play an important role in study data management and overall clinical operations of the prospective randomized studies.
p>Translational Medicine (TMed) drives early clinical development of novel therapeutics by partnering with Discovery Sciences and Late-Stage Clinical Research to translate scientific discoveries into human proof-of-concept and advance the most promising candidates through the pipeline to patients. Leads and directs teams through key study planning, development, and execution activities, including program overviews, issue escalation and mitigation, senior management presentations, cross-functional governance meetings, and advisory meeting preparation.
Overview As a member of the clinical research team, the Clinical Research Coordinator's responsibilities will be associated with multiple clinical research projects including dietary intervention studies, pharmaceutical trials, studies evaluating novel diabetes care technologies, with an emphasis on weight management in diabetes. Recruits, schedules, and interviews patients, performs routine laboratory procedures (including measuring blood pressure, height and weight, blood glucose), and escorts patients to testing locations.
In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
p>The Clinical Research Coordinator II (CRC II) supports all phases of the study lifecycle, conducts patient recruitment, consenting, administers questionnaires, abstracts medical records, procures, processes and ships research specimens, maintains patient databases, enters data into sponsor-specific electronic data capture forms, performs administrative tasks, assists in grant preparation, and participates with the research team in preparation of data and other reports. The CRC-II procures, processes and ships research specimens and conducts patient recruitment/consenting, administers questionnaires, abstracts medical records, maintains patient databases, enters data into sponsor-specific electronic data capture forms, performs administrative tasks, assists in grant preparation, and participates with the research team in preparation of data and other reports.
The CRC procures, processes and ships research specimens and conducts patient recruitment, administers questionnaires, abstracts medical records, maintains patient databases, enters data into sponsor-specific electronic data capture forms, performs administrative tasks, assists in grant preparation, and participates with the research team in preparation of data and other reports. Career Advancement/Professional Development: Access a wealth of ongoing training and development opportunities that will not only enhance your skills but also expand your knowledge base especially for individuals pursuing careers in medicine or biomedical research.
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Boston, Massachusetts24 days ago
He/she will work in close collaboration with translational/biomarker, project and clinical teams to develop and implement internal and external biomarker activities and perform studies to support indication/patient selection opportunities. Ability to maintain timely and detailed notes using electronic lab notebook as well as demonstrated experience using Microsoft Excel and GraphPad Prism.
p>ā¢ Accurately enter and manage data within the Clinical Trial Management System (CTMS) by: tracking completed training information that could carry over to other studies; maintaining site information and rosters; reviewing monitoring reports to identify deficiencies, reviewing adequacy of issue escalation and issue resolution; and provide feedback to appropriate CRO contacts. This role is responsible for key site management and study start-up activities, including feasibility assessments, site selection support, maintenance of trial master files (eTMF), and oversight of clinical trial systems such as CTMS.
He/she will work in close collaboration with translational/biomarker, project and clinical teams to develop and implement internal and external biomarker activities and perform studies to support indication/patient selection opportunities. The individual in this role will be responsible for designing and executing robust translational experiments in clinically relevant models to support indication selection and patient stratification.
This position is embedded within the BIDMC Clinical Research Coordinator Core, a centralized resource serving investigators across departments and divisions throughout the medical center, and operates in affiliation with the institutions Clinical Research Center, a member of Harvard Catalyst - Harvards Clinical and Translational Science Center. Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving.
Conducts library searches ā¢ Verifies accuracy of study forms ā¢ Updates study forms per protocol ā¢ Documents patient visits and procedures ā¢ Assists with regulatory binders and QA/QC procedures ā¢ Assists with interviewing study subjects ā¢ Administers and scores questionnaires ā¢ Provides basic explanation of study and in some cases obtains informed consent from subjects ā¢ Performs study procedures, which may include phlebotomy ā¢ Assists with study regulatory submissions ā¢ Writes consent forms ā¢ Verifies subject inclusion/exclusion criteria ā¢ Performs administrative support duties as required. SKILLS/ABILITIES/COMPETENCIES REQUIRED: ā¢ Careful attention to details ā¢ Good organizational skills ā¢ Ability to follow directions ā¢ Good communication skills ā¢ Computer literacy ā¢ Working knowledge of clinical research protocols ā¢ Ability to demonstrate respect and professionalism for subjects' rights and individual needs.
ul>Competencies and Personal Traits:- What We Do:
- Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
- Why We Do It:
- Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world.
Boston, Massachusetts16 days ago
SKILLS/ABILITIES/COMPETENCIES REQUIRED: - Careful attention to details - 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 subjectsā rights and individual needs The Clinical Research Coordinator II should also possess: - Ability to work independently and as a team player - Analytical skills and ability to resolve technical problems - Ability to interpret acceptability of data results - Working knowledge of data management program. - Conducts library searches - Verifies accuracy of study forms - Updates study forms per protocol - Documents patient visits and procedures - Assists with regulatory binders and QA/QC procedures - Assists with interviewing study subjects - Administers and scores questionnaires - Provides basic explanation of study and in some cases obtains informed consent from subjects - Performs study procedures, which may include phlebotomy.
The CRC (Clinical Research Coordinators) work within the Breast Oncology 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 and the Clinical Research Manager. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
Start Mode Car Transit Bike Walk Transit Bus Subway Train Tram Rail Default Fewer transfers Less walking Avoid Tolls Highways Ferries G Google Maps Apple Maps Waze Apple Maps doesn't support Bike mode; we'll open Driving. Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving.
p>Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc. and maintaining and updating data generated by the study. The Clinical Research Coordinator will support a variety of clinical research studies focusing on treatment for the invisible wounds of war, including evidence-based treatments for PTSD and TBI, mindfulness and wellness-focused modalities, military family care programming, community provider education, etc.
li>Perform various tasks (post-onboarding) such as use of proprietary technology, performing the Informed Consent process, documenting medical history and medications, taking vitals, scribing for medical staff, dispensing study drug, performing allergy skin tests, documenting controlled environment stats, and other ophthalmic assessments. Our CRC I's will partner with tenured Clinical Research Coordinators and Clinical Project Managers to execute protocol directives and work cross-functionally with internal and external teams such as other Research Coordinators and Investigators.
Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. Compensation may exceed the base hourly rate depending on shift differentials, call pay, premium pay, overtime pay, and other additional pay practices, as applicable to the position and in accordance with the law.
Somerville, MA30+ days ago
Working independently and following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc. Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.
Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc. As a member of the integrative Anesthesia Research Center the CRC, working closely in collaboration with other research coordinators, will be responsible for managing recruitment of patients in multiple clinical trials, participating in data collection and entry, as well as ensuring compliance with federal, state and institutional guidelines.
The variety of tasks associated with this position, include, but are not limited to the following: assisting with study administrative tasks such as, IRB communications and document development, site management and startup activities, writing progress reports, scientific writing (including drafting manuscripts, abstracts, posters, and PowerPoint presentations),āÆ grant applications, medical chart review, completion of case report forms, data extraction and upload, site staff communication and patient contact for research studies, and maintain the section's OpenScholar website. Smith Center for Outcomes Research, Electrophysiology & Digital Health Section at BIDMC is seeking a highly motivated Clinical Research Coordinator to be responsible for the managing/overseeing of recruiting, screening and enrolling of patients for participation in a multiple clinical trial, ensuring compliance with federal, state and institutional guidelines.
The CRC (Clinical Research Coordinators) work within the Lymphoma 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 and the Clinical Research Manager. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
BROOKLINE, MA30+ days ago
p>The CRC (Clinical Research Coordinator) will work within the Immune Effector Cell Therapy 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 and the Clinical Research Manager. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
p>The CRC (Clinical Research Coordinators) work within the Multiple Myeloma 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 and the Clinical Research Manager. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
p>The CRC (Clinical Research Coordinators) work 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 and the Clinical Research Manager. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
The CRC (Clinical Research Coordinators) work within the Breast Oncology 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 and the Clinical Research Manager. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
p>The CRC (Clinical Research Coordinators) work 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 and the Clinical Research Manager. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
p>The CRC (Clinical Research Coordinators) work within the Head & Neck Oncology 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 and the Clinical Research Manager. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
p>The CRC (Clinical Research Coordinators) work within the Head & Neck Oncology 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 and the Clinical Research Manager. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
p>The CRC (Clinical Research Coordinator) will work within the Thoracic Oncology 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 and the Clinical Research Manager. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
p>Site: The Brigham and Women''s Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success.
Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. Ensure that study visits and source documents are completed in accordance with study protocols, including verifying the work of other staff members .