Clinical Data Associate

Mayo Clinic

1d•Hybrid

About The Position

Under the direct supervision of the study team and research leadership, assists in coordinating the details of the study and documentation concerning study protocols, patient scheduling, retrospective & prospective chart work, data collection, data entry, data management, follow-up information, and compliance with federal, state, sponsor, and institutional guidelines. Overview for the Clinical Data Associate I (CDA I): The CDA I provides data management support for clinical trials. The CDA I is responsible for data collection in a timely manner by performing data abstraction of clinical and demographic information from the electronic medical record and case report forms into the study specific electronic data capture system, as well as leading and assisting the data team in their roles. The CDA I manages the study database as directed. The CDA I performs other administrative duties related to the study as assigned including creation of source documents, redaction of protected patient information under HIPAA privacy laws, and sending/faxing query resolutions to industry sponsors or CRO personnel. The CDA I is responsible for scheduling clinical research monitor visits, maintaining the monitor visit calendar, and serving as the campus visitor escort to pharmacy, radiology, BAP Lab, and other locations on campus, as needed. The CDA I independently prioritizes assignments and completes ongoing tasks following established research regulatory guidelines and best practices, and may assist with general office responsibilities or research related projects. CDA I’s perform administrative functions to support work unit and maintain continuing education requirements as required for the position by the completion of Human Subject Protection and Good Clinical Practice (GCP) trainings at initial employment and every 3 years thereafter As a hybrid role, this is a work arrangement that supports a combination of offsite (remote) and on-site work according to business needs. On-site expectations are determined by the supervisor and will be discussed during the interview. Visa sponsorship is not available for this position. This position is not eligible for F-1 OPT STEM extension.

Responsibilities

Assists in coordinating the details of the study and documentation concerning study protocols, patient scheduling, retrospective & prospective chart work, data collection, data entry, data management, follow-up information, and compliance with federal, state, sponsor, and institutional guidelines.
Provides data management support for clinical trials.
Responsible for data collection in a timely manner by performing data abstraction of clinical and demographic information from the electronic medical record and case report forms into the study specific electronic data capture system, as well as leading and assisting the data team in their roles.
Manages the study database as directed.
Performs other administrative duties related to the study as assigned including creation of source documents, redaction of protected patient information under HIPAA privacy laws, and sending/faxing query resolutions to industry sponsors or CRO personnel.
Responsible for scheduling clinical research monitor visits, maintaining the monitor visit calendar, and serving as the campus visitor escort to pharmacy, radiology, BAP Lab, and other locations on campus, as needed.
Independently prioritizes assignments and completes ongoing tasks following established research regulatory guidelines and best practices, and may assist with general office responsibilities or research related projects.
Performs administrative functions to support work unit and maintain continuing education requirements as required for the position by the completion of Human Subject Protection and Good Clinical Practice (GCP) trainings at initial employment and every 3 years thereafter