Clinical Research Data Specialist I

Mass General Brigham•Boston, MA

3d•$20 - $29•Remote

About The Position

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. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The Clinical Research Data Specialist I (CRDS I) works under general supervision to extract clinical data and research data from electronic medical records and other sources and enters this data into electronic data capture system utilized for the clinical research protocol. The CRDS I will be responsible for entering data for multiple oncology clinical trials. The CRDS 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. Summary Works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research.

Requirements

Careful attention to detail
Good organizational skills
Ability to follow directions
Good communication skills
Computer literacy
Working knowledge of clinical research protocols
Bachelor's Degree Related Field of Study required
Attention to detail.
Ability to recognize compliance and data integrity issues and respond appropriately.
Working knowledge of clinical research protocols.
Ability to communicate effectively with patients, vendors, contract research organizations and professional staff.
Effective interpersonal and communication skills.

Nice To Haves

Research Related Experience 1-2 years preferred

Responsibilities

Proactively track assigned research subject’s upcoming protocol appointments and visits and document on central clinical research data specialist (CRDSP) tracker
Effectively monitor research subject condition and take appropriate action to ensure compliance with research protocol data entry requirements
Proactively take steps to obtain missing source documents from all relevant sources
Identify inaccurate source documents and track source document inconsistencies until resolved.
Ensure accurate and timely entry of required data into various study-specific electronic data-capture systems.
Ensure appropriate documentation of own study-specific delegation and training prior to entering data.
Ensure adequate source documentation is in place prior to entering data.
Obtain and abstract complex clinical information from multiple sources (medical records, research records, etc.) for research subjects.
Independently manage adverse event (AE) and concomitant medication (CM) data as required by the sponsor, institution, and federal regulations
Independently manage tumor response data entry
Enter vital signs and EKGs into study-specific electronic data-capture system independently as required for individual studies
Enter quality of life assessments into study-specific electronic data-capture system independently as required for individual studies
Enter all required correlative research blood samples and clinical safety laboratory specimen results into study-specific electronic data-capture system independently as required for individual studies
Enter all protocol required tests and procedures independently into study-specific electronic data-capture system as required for individual studies
Work professionally with sponsor representatives to review and correct data recorded in the case report forms.
Track and appropriately manage sponsor data entry deadlines
Resolve and answer data queries with minimal errors.
Perform standard data management quality control steps.
Maintain awareness of details of clinical data to identify missing or inaccurate data; and track data inconsistencies for team to review and report accordingly.
Remain flexible and adapt to change and variety on the job.
Effectively handle unexpected situations and changing research subject and protocol conditions
Develop individual research visit flow charts, intake sheets, and other tools as needed to independently ensure timely and accurate data entry
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.
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 maintain a record of all correspondence related to these visits.