Note: The job is a remote job and is open to candidates in USA. Mass General Brigham is a not-for-profit organization that supports patient care, research, teaching, and community service. The Clinical Research Data Specialist I will extract and enter clinical data into electronic systems for oncology clinical trials, ensuring compliance with research protocols and managing data quality.
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
- Bachelor's Degree Related Field of Study 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
- Attention to detail
- Ability to recognize compliance and data integrity issues and respond appropriately
- Ability to communicate effectively with patients, vendors, contract research organizations and professional staff
- Effective interpersonal and communication skills
- Research Related Experience 1-2 years preferred
Benefits
- In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth.
- We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
- To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.
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