- Manage and oversee day-to-day operations and ensure integrity of clinical trials.
- Prepare protocol applications, staff and protocol amendments, safety reports, adverse event reports, and other regulatory submissions to local IRB and central IRBs.
- Report to Project Manager and lab PI and communicate trial status, including IRB approval, continuing reviews, recruitment and enrollment reports, and subjects' appointments and surgeries.
- Manage and maintain regulatory documents for audit and routine Sponsor monitoring visits.
- Work with physicians and sub-investigators and use in-house API tools to identify potential clinical trial candidates. Screen eligible clinical trial subjects, and lead recruitment and retention efforts.
- Review medical records and laboratory results for study relevant clinical data.
- Coordinate with clinical care team to schedule study visits. Attend study visits and subsequent assessments as outlined in Study Protocols. Complete monthly recruitment and enrollment reports for Study PI and Sponsors.
- Conduct ongoing review of study progress and communicate concerns with the study investigator and the subject's primary care provider.
- Enter collected data into electronic data capture systems, e.g., Medidata, Veeva per EDC completion guidelines.
- Maintain confidential patient files including all correspondence, information, raw data, and followup status of study subjects.
- Assist project manager in organization of site qualification/feasibility visits, site initiation visits, and closeout visits with Sponsors.
- Desired: Experience in processing, storing, and shipping biospecimens
- Desired: Oversee clinical trial budgets, electronic billing, Sponsor invoicing, and reconciliation of financial statements. Maintain communication channels with hospital grant department, financial analysts, and Clinical Trials Office, to address any administrative issue in a timely manner.
- Independence, problem-solving capabilities, and willingness and dedication to troubleshoot technical issues
- Knowledge of data management concepts, HIPAA/patient data privacy regulations, ICH Good Clinical Practice, and federal Human Subjects Protections requirements. Quick to learn institutional guidelines and policies
- Excellent interpersonal and communication skills. Ability to interact effectively with many different people including patients, doctors, nurses, grant administrators, project and program managers, and researchers
- Exceptional organizational skills and the flexibility to handle multiple tasks and deadlines
- Computer skills including configuration of operating systems, word processing, email, and spreadsheets
- Good command of English language, including basic medical and scientific terminology
- Desired: familiarity with research contract negotiation process
- Desired: familiarity with OnCore CTMS and EPIC EMR
- Perform hospital billing review for patients enrolled in clinical trials. Assist clinical coordinators with insurance inquiries and prior authorization requests.
- Submit and track sponsor invoices for milestone payments, patient care corrections, and reimbursements and research stipends as needed.
- Submit staff expense reports for reimbursement and per-contract work.
- In coordination with departmental grant manager, reconcile study funds against invoices and follow up on outstanding payments.
- Purchase clinical trial equipment and supplies, as necessary, as allowed by clinical trial agreements.
- Purchase other general lab supplies, as necessary.
-
Research Coordinator
3 weeks ago
Boston University Boston, United StatesThe Communication and Neurodevelopment Lab at Boston University ) is dedicated to studying speech, language, and reading development in an effort to promote positive outcomes for all children, especially those susceptible to communication difficulties. Our research involves an in ...
-
Clinical Research Coordinator
3 days ago
Xsphera Biosciences Inc Boston, United StatesSummary: · Xsphera Biosciences is a Boston-based biotechnology startup focused on delivering functional, precision immuno-oncology solutions for drug development and patient care. The company's patented science, originally developed at the Dana-Farber Cancer Institute, captures ...
-
Clinical Research Coordinator
4 days ago
Hub Technology Group Boston, United StatesLOCAL W2 Candidates Only · Junior Level Role - 1-3 Years · The Clinical Research Coordinator work within the clinical research program and support the research team in the overall conduct of clinical trials and research · 1-3years of clinical research, public health research exp ...
-
Clinical Research Coordinator
3 weeks ago
Partners Healthcare System Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Inflammatory Bowel Disease (IBD) Group in the Digestive Healthcare Center at the Massachusetts General Hospital seeks a highly motivated, self-directed individual for the position of Clinical Research Coordinator (CRC). The mission of ou ...
-
Clinical Research Coordinator
3 weeks ago
Massachusetts General Hospital Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Liver Center in the Division of Gastroenterology at the Massachusetts General Hospital is recruiting a full-time Clinical Research Coordinator to join its multidisciplinary team in January 2024. This position will be under the direct sup ...
-
Research Enrollment Coordinator
3 weeks ago
Brigham and Women's Hospital Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · Mass General Brigham Personalized Medicine is looking for a motivated and energetic Research Enrollment Coordinator to drive recruitment for two related research programs at Massachusetts General Hospital. Both programs are at the forefront ...
-
Clinical Research Coordinator
3 weeks ago
Beth Israel Lahey Health Boston, United StatesWhen you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · Regular · Scheduled Hours: · 40 · Work Shift: · Day (United States of America) · The Division of Research in the Department of Obstetrics and Gynecology ...
-
Clinical Research Coordinator
1 week ago
Beth Israel Lahey Health Boston, United States**Job 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, youre making a difference in peoples lives.** · Fluency in Portuguese, Cape ...
-
Clinical Research Coordinator
3 weeks ago
Massachusetts General Hospital Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Division of General Internal Medicine (DGIM) at Massachusetts General Hospital is seeking a Research Assistant (Clinical Research Coordinator) to join our research team. · The successful candidate will work on multiple clinical epidemiol ...
-
Behavioral Research Coordinator
1 week ago
Harvard University Boston, United StatesBehavioral Research Services (BRS) serves the data collection needs of Harvard Business School (HBS) faculty, doctoral students, and their collaborators conducting a broad range of research, including laboratory and field experiments, online data col Research Coordinator, Behavio ...
-
Clinical Research Coordinator
3 weeks ago
Beth Israel Lahey Health Boston, United StatesWhen you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · Regular · Scheduled Hours: · 40 · Work Shift: · Day (United States of America) · The Berenson-Allen Center for Noninvasive Brain Simulation is a world le ...
-
Clinical Research Coordinator
3 weeks ago
Beth Israel Lahey Health Boston, United StatesWhen you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · Regular · Scheduled Hours: · 40 · Work Shift: · Day (United States of America) · The Berenson-Allen Center for Noninvasive Brain Stimulation is a world l ...
-
Clinical Research Coordinator
3 weeks ago
Beth Israel Lahey Health Boston, United StatesWhen you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · Regular · Scheduled Hours: · 40 · Work Shift: · Day (United States of America) · The Department of Neurology at Beth Israel Deaconess Medical Center prov ...
-
eMERGE Research Enrollment Coordinator
3 weeks ago
Brigham and Women's Hospital Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · Mass General Brigham Personalized Medicine is looking for a motivated and energetic Research Enrollment Coordinator to drive recruitment for the eMERGE study at Mass General Brigham. The eMERGE study is at the forefront of integrating genomi ...
-
Sr. Clinical Research Coordinator
3 weeks ago
Beth Israel Lahey Health Boston, United StatesWhen you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · Regular · Scheduled Hours: · 40 · Work Shift: · Day (United States of America) · This Senior Clinical Research Coordinator position will support the Card ...
-
Clinical Research Coordinator I
3 weeks ago
Massachusetts General Hospital Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The Massachusetts General Hospital Center for Aging and Serious Illness (CASI) is seeking Clinical Research Coordinators to support ongoing clinical research focused on patient-centered and caregiver outcomes and improving the lives of older ...
-
Clinical Research Coordinator II
3 weeks ago
Beth Israel Lahey Health Boston, United StatesWhen you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · Regular · Scheduled Hours: · 40 · Work Shift: · Day (United States of America) · This Clinical Research Coordinator II position will support the Center f ...
-
Clinical Research Coordinator II
3 weeks ago
Beth Israel Lahey Health Boston, United StatesWhen you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · Regular · Scheduled Hours: · 40 · Work Shift: · Day (United States of America) · Responsible for screening patients for participation in clinical trials, ...
-
Clinical Research Coordinator II
1 week ago
Beth Israel Lahey Health Boston, United States**Job Type:** Regular · **Time Type:** Full time · **Work Shift:** Rotating (United States of America) · **FLSA Status:** Non-Exempt · **When you join the growing BILH team, you're not just taking a job, youre making a difference in peoples lives.** · Responsible for screeni ...
-
Clinical Research Coordinator
3 weeks ago
Partners Healthcare System Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · Drs. Hamed Khalili and Tracey Simon of the Massachusetts General Hospital Gastrointestinal Unit are in search of a Clinical Research Coordinator to work on the NIH Nutrition for Precision Health (NPH) study and research involving patients wi ...
Clinical Research Coordinator - Boston, United States - Partners Healthcare System
Description
GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Brain Modulation Lab in the Department of Neurosurgery at Massachusetts General Hospital seeks a highly motivated, detail-oriented, self-directed Clinical Research Coordinator II for the management of clinical trials and research.
This individual will be responsible for all tasks related to data and sample collection for ongoing clinical trials including subject recruitment and enrollment, follow-up visits and phone calls, capturing clinical data, conducting study visits, and maintaining relationships with Sponsors and collaborators.
There will be a strong focus on patient recruitment and retention, completing clinical trial related tasks, and other regulatory responsibilities.
This individual will work in close collaboration with the PI (Mark Richardson, MD PhD) and clinical research project manager and will routinely interact with patients, nurses, and physicians.
A minimum of 1-year experience of clinical trial execution and experience with regulatory documentation is required. Clinical research certification (such as CCRC, CCRP or other certification approved by the PI) is highly preferred.A candidate will be considered if they demonstrate equivalent work experience and commits to obtaining certification within months of hire date.
A minimum 2 year commitment will be preferred given the complexity of the work.Clinical Trial Responsibilities:
Skills and competencies:
LICENSES, CERTIFICATIONS, and/or REGISTRATIONS:
Clinical Research Coordinator Certification (CRCC) - highly preferred.
Candidates who are able to demonstrate equivalent work experience and commit to obtaining certification within months of hire date will be considered.
EDUCATION:
Bachelor's degree in a science or healthcare related-field is required.
EXPERIENCE:
A minimum of 1-year experience with clinical trial execution and experience with regulatory documentation is required. Experience in investigational drug or device studies and gene therapy strongly preferred.
SUPERVISORY RESPONSIBILITY:
None
FISCAL RESPONSIBILITY:
WORKING CONDITIONS:
Hybrid. Duties will be primarily performed in a hospital inpatient, operative, clinic, and office settings. Some responsibilities are able to be performed remotely.
