Research Data Specialist
OneOncology•Grand Rapids, MI
1d
About The Position
Position Overview: As the Research Data Specialist, you will be responsible for collecting, transcribing, and transmitting clinical data for multiple investigational drug studies performed. This role provides accurate / clean data in a timely manner for pharmaceutical sponsors waiting to determine the next dose level. The Research Data Specialists are a main point of contact between CRO and site level, they schedule and facilitate visits with the Clinical Research Associates from the CRO for each trial that they are assigned to.
Requirements
- Working knowledge of medical and pharmaceutical terminology.
- Data collection experience
- Research knowledge
Nice To Haves
- Bachelor’s degree (preferred) in life sciences of equivalent. May consider associate degree with applicable experience.
Responsibilities
- Receives and requests data from patient records; completes (as appropriate) paper and electronic case report forms (CRFs).
- Reviews patient data for completeness and accuracy.
- Identifies, enters Adverse Events (AEs) in CRFs (as appropriate).
- Performs data entry and transmits data to sponsors as required.
- Coordinates and schedules monitor(s) visits with availability of research coordinator, pharmacy and investigator in mind.
- Meets with sponsor/monitors, along with research coordinator, to review data entry.
- Provides support and information to monitors as necessary and as directed by supervisor(s).
- Retrieves missing data promptly to ensure completeness of CRFs.
- Assures that data entry remains current for all studies per SOP.
- Ensures that study team is aware of data deadlines.
- Reviews and utilizes protocols as guides for study activities.
- Maintains a study tracking file as assigned for each study and communicates as needed with accounts receivable staff regarding submitted data.
- Attends meetings and briefings regarding clinical studies as required.
- Assists in the success of the research department by performing other tasks as assigned.
- All other duties as assigned.
