Job Description:
Job Summary:
As an integral member of the research team and in compliance with all regulatory, institutional, and departmental requirements, performs data collection, data entry and data analysis for research projects, databases, and research protocols within the organization. Ensures data quality and integrity during each phase of data collection and for each protocol assigned.
Data Collection/Data Entry :
- Utilizes appropriate methodologies to collect human subject information for a research project, database, and/or protocol.
Performance Expectations :
- Performs abstraction of data from source records in patient/human subject records (e.g., electronic medical record, laboratory or diagnostic test results, surgical/radiation treatments delivered); abstraction of data from publications, or data collection from outside physicians’ offices.
- If applicable, completes necessary data collection requirements for interdepartmental research projects, databases, and/or protocols.
- Redacts source documentation as needed to ensure compliance with the Health Information Portability and Accountability Act (HIPAA) and other regulations.
- Uses research databases (e.g., sponsor electronic Case Report Forms, Medidata, RedCAP and Clinical Trials Management System (CTMS)) etc. efficiently to complete assigned tasks.
- Enters data into the relevant data collection systems as per established protocol or project timelines.
- Ensures data are accurate and complete.
- Recommends changes/additions to established data fields, if needed.
- Performs queries in databases to identify missing data variables.
- Utilizes the Clinical Trial Management System (CTMS) with accuracy and timeliness registering patients and tracking visits.
- Stays up-to-date with system changes that affect job responsibilities.
- Attends required Clinical Research Administration (CRA) training, protocol training classes and systems training (e.g. CTMS Training).
- Attends departmental research meetings or service trainings, as needed.
- May recruit, consent, interview and collect relevant data from human subjects enrolled to non-therapeutic, minimal risk studies for selected departments at the discretion of the Manager.
Data Reporting:
- Generates reports to all necessary parties on the progress of the research project, database, or protocol.
- Facilitates and acts as primary liaison for monitoring visits and audits conducted by outside sponsors or internal CR QA.
Performance Expectations :
- Generates reports for Principal investigator, sponsoring agency, Institutional Review Board, DSM Committees, manager etc., as needed.
- Compiles data and assists in consolidating/analyzing data for presentation.
- Performs and/or responds to queries and/or assist with statistical analyses, as needed.
- Provides real-time updates on data entry status to study team and supervisor.
- Communicates to the manager or study team when there are any issues or questions regarding missing or incomplete participant data and identifies trends or gaps in source data availability or accuracy.
- Meets regularly with the manager or study team members to review study data progress.
- Reviews monitoring queries and enters appropriate data in the CRF.
- For complex queries, partners with clinical team (CTN, physician) to obtain responses to questions and then enters data in the database.
Quality Assurance:
- Participates in activities to ensure accurate and complete data and regulatory compliance.
Required Skills & Experience:
- Client will allow any amount of experience. If there is none, this should be escalated.
- Medical/Research Experience required with HS diploma/GED.
- Beginner written communication skills including composing written correspondence and presenting information in a clear and concise manner.
- Beginner analytical skills including the ability to abstract information from clinical documents and enter data into the appropriate database.
- Ability to enter data accurately.
- This position may require the incumbent to complete tasks of standard to moderate difficulty under limited supervision and/or to assist more senior research staff in working on more difficult assignments.
- Computer Skills: The ability to use a computer and software such as database management, spreadsheet, word processing and graphics applications.
Preferred Skills & Experience:
- Two-four (2-4) years of experience preferred.
- Medical/Research Experience preferred with Bachelor's degree.
- A strong familiarity with Internet searching.
- Medical terminology and an interest in science.
- Medical/Research Experience.
Required Education:
- HS Diploma/GED.
Preferred Education:
- Bachelor's Degree.
Preferred Certifications & Licensure:
- Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals (ACRP).
