Research Data Specialist

OneOncology•Grand Rapids, MI

1d•Onsite

About The Position

The Research Data Specialist collects, transcribes, and transmits clinical data for multiple investigational drug studies. The role provides accurate, clean data in a timely manner for pharmaceutical sponsors and serves as a main point of contact between contract research organizations (CROs) and the site. The specialist schedules and facilitates CRO Clinical Research Associate visits for assigned trials.

Requirements

Working knowledge of medical and pharmaceutical terminology.
Data collection experience.
Research knowledge.

Nice To Haves

Bachelor’s degree in life sciences or equivalent is preferred.
An associate degree with applicable experience may be considered.

Responsibilities

Receive and request data from patient records and complete paper and electronic case report forms (CRFs), as appropriate.
Review patient data for completeness and accuracy.
Identify and enter adverse events (AEs) in CRFs, as appropriate.
Enter data and transmit it to sponsors as required.
Coordinate and schedule monitor visits, considering the availability of the research coordinator, pharmacy, and investigator.
Meet with sponsors and monitors, along with the research coordinator, to review data entry; provide support and information to monitors as directed by supervisors.
Retrieve missing data promptly to ensure CRFs are complete.
Keep data entry current for all studies in accordance with SOPs and ensure the study team is aware of data deadlines.
Review and use protocols as guides for study activities.
Maintain an assigned study tracking file and communicate with accounts receivable staff as needed regarding submitted data.
Attend meetings and briefings about clinical studies as required.
Perform other tasks as assigned to support the research department.