Under direct supervision, this position is responsible for the collection, coordination, processing, and quality control of clinical trial data. Maintains research protocol and other research files as applicable.
Ensure data generated from clinical trials is collected, accurately recorded, and sent to the appropriate data center in a timely manner.
Ensure computers and software used to generate and record data comply with Part 11 and Privacy Rule requirements.
Manage the databases maintained on site.
Collect data via medical records, lab reports, and study records. This responsibility includes recording data via hard copy or electronically, reviewing data for accuracy and completeness, and clarifying data with research staff as necessary.
Transmit data in a timely manner as required by the protocol.
Actively participates in monitoring and auditing visits ensuring that all data and queries are in accordance with sponsor requirements. This responsibility includes correcting and revising data as appropriate.
Assist with ordering and maintaining research supplies. Assist with collecting and processing specimens, imaging documents, and other items required for research purposes.
Located at Lutheran Medical Center
Certification, Registration, License:
Knowledge, Skills and Abilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements list must be representative of the knowledge, skills, minimum education, training, licensure, experience, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.