Clinical Research Data Specialist I

Site: Mass General Brigham Incorporated

 

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.

The CRDS I will perform the following responsibilities under general supervision by the Clinical Research Manager:

· 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


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

 

Job Summary

Summary<br>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.<br><br>Does this position require Patient Care?<br>No<br><br>Essential Functions<br>-Maintain and organize study-specific