[Remote] Clinical Research Data Specialist I
Note: The job is a remote job and is open to candidates in USA. Mass General Brigham is a not-for-profit organization focused on patient care, research, teaching, and community service. The Clinical Research Data Specialist I (CRDS I) is responsible for extracting and entering clinical data from electronic medical records for oncology clinical trials, ensuring compliance with research protocol data entry requirements.
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
Skills
- 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
Benefits
- Comprehensive benefits
- Career advancement opportunities
- Differentials
- Premiums
- Bonuses
- Recognition programs designed to celebrate your contributions and support your professional growth
Company Overview
Company H1B Sponsorship