Clinical Trials Data Coordinator

Job Description

General Summary

Responsible for the organization, abstraction, coding, entry, maintenance and accuracy of patient clinical research data in a timely, efficient manner. Must strictly adhere to guidelines regarding honest, complete reporting of sensitive and confidential patient information. Understands the importance/impact of data integrity in terms of patient management, study results, cost efficiency, quality of service and the goals of scientific research. Use of good judgement, tact and sensitivity required in regular contact with physicians, other health care personnel and occasionally patients.

Responsibilities

Duties and Responsibilities

Essential Functions:

• Collects, abstracts/codes and compiles patient clinical data for research purposes from a variety of sources including electronic records, medical charts, laboratory reports and clinical databases. Submits complete research data records to outside agencies or sponsors, if applicable.
• Maintains a research chart/data record for each patient enrolled in a clinical trial. Develops databases or spreadsheets to monitor data collection and submission according to the requirements of each research protocol.
• Identifies appropriate data sources and abstracts data required to complete pre-study forms, flow sheets, off study forms and other special forms for research protocol patients.
• Initiates forms/appropriate procedures to obtain and submit pathology materials, x-rays, operative reports, data from physicians or other specialized forms for research protocol patients. Assists other departments (e.g., Pathology, Surgery, Radiation Therapy) with data collection and submission required for clinical trials.
• Designs and creates data collection forms, coding instructions, verification procedures and quality control checks to insure data integrity.
• Maintains a system for effective data flow and timely completion/submission of research patient data. Copies and submits required data to statistical centers. Documents data submission.
• May assist in performing statistical analysis of research data, developing reports, abstracts or manuscripts and graphics for presentation of research project status/results.
• Responds to follow-up data queries and obtains required follow-up data on patients per protocol requirements.
• Assists investigations with special requests for data retrieval for research studies.
• Prepares for and participates in audits of research protocol patients' records. Corrects errors in data as necessary.
• May communicate with and obtain data/information directly from patients (e.g., patient recruitment, reminders, scheduling clinical visits or tests, interviewing patients using structured questionnaire).
• Answers telephone, screens calls, takes messages and provides information according to established research protocols, programs and policies.
• Composes research correspondence, memos, reports and minutes of meetings as requested.

Common Expectations:

• Is knowledgeable of and complies with institutional research policies, procedures and guidelines. With the oversight of the Director of Research/Human Subjects Protection Administrator, has knowledge of and complies with governmental regulations regarding responsible conduct of research, research ethics and integrity and protection of the safety and welfare of human subjects (i.e., DHHS, FDA and IRB research regulations, HIPAA privacy and research regulations and others as applicable, such as those governing specimen banks, genetic research, etc.). Instructs less experienced personnel and advises others to insure that research is conducted safely and in compliance with the above. Reports apparent or potential problems to the Director of Research/Human Subject Protection Administrator and the appropriate Service Line Leader.
• Enhances professional growth and development through participation in educational programs, current literature, inservice meetings, and workshops.
• Provides outstanding service to all customers; fosters teamwork; and practices fiscal responsibility through improvement and innovation.

Qualifications

Qualifications

Minimum Education:

• Certificate Program Post High School Vocational/Specialized Training Required
• Bachelors Degree In medically related field. Preferred

Work Experience:

• 1 year Training in medical record/health information systems. Required and
• Training/experience in the responsible conduct of research, including medical/ research ethics and protection of the safety and welfare of human subjects in research. Required

Courses and Training:

• Medical terminology. Upon Hire Required and
• Word and data processing. Upon Hire Required and
• Medical record abstraction. Upon Hire Required

Knowledge, Skills, and Abilities:

• Excellent attention to detail and data accuracy.
• Versed in medical terminology, laboratory tests and use of medical records for data abstraction.
• Ability to follow multiple, detailed directions of various protocols and submit data according to schedules.
• Excellent computer skills including electronic patient information systems, word processing, spreadsheet, relational database, and graphics software.

Benefits Offered:

• Comprehensive health benefits
• Retirement savings plan
• Paid time off (PTO)
• Education assistance
• Financial education and support, including DailyPay
• Expanded Paid Parental Leave

For additional details: Benefits & Incentives | WellSpan Careers (joinwellspan.org)