Clinical Research Coordinator, Ob/Gyn Research Support Unit

Minimum Qualifications: 

• Bachelor's degree or equivalent, and two years of directly related experience. 

• Preferred Qualifications: 
   
• Two years of experience
   
• ACRP or SOCRA Certification 
   
• Bilingual (Spanish) a plus
   

Job Description:

The Clinical Research Coordinator obtains human subject data for clinical research activities via methods specified in the study protocol and performs general administrative duties supporting the study.

Job Duties: 
The duties of this role will include but are not limited to the following:

• Obtain human subject data for clinical research activities via methods specified in the study protocol and performs general administrative duties supporting the study.
   
• Schedules, coordinates, and participates in the pre-site visit and site initiation visits, coordinates study initiation.
   
• Maintains and monitors source documentation and appropriate forms as per protocol for quality and accuracy, including participant records; assists with the quality assurance process. 
   
• Incorporates directions from other health care disciplines into clinical research protocols when reviewing patient eligibility; assists in eliciting relevant data from sources outside of the hospital. 
   
• Develops and maintains productive working relationship with the study monitor; attends and participates in campus coordinator workshops. 
   
• Identifies and recruits clinical research subjects for participation of studies, collects data, and monitors enrollment goals. 
   
• Mentors new clinical research coordinators and assistant clinical research coordinators.
   
• Assists with grant/protocol preparation and submission to IRB, OCR or OSP under direction of research coordinator under the direction of the PI and with answering IRB stipulations to obtain final approval, documents IRB approval and contract approval.
   
• Under direction of PI may draft various communications with Sponsor and/or regulatory documents to be sent to the Sponsor. 
   
• May assist PI and/or research nurse coordinator in the planning and design of source documents for protocol. 
   
• Assists in developing procedures for laboratory collection and storage. 
   
• Process and ship lab specimens; retrieves and/or sends identified research specimens certified if indicated as per regulations.
   
• Assists in precepting new clinical research staff and educating other research staff regarding scientific aspects of studies. 
   
• Process and ship lab specimens efficiently and cost effectively; maintains supply inventory and equipment; maintains regulatory standards. 
   
• Assists with the budget development as requested. 
   
• Adheres to internal controls established for department. 
   
• Obtain Informed Consent from study participant and documents appropriately. 
   
• Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other regulatory activities.
   
• Reconciles study drug accountability; maintains temperature and QC logs per protocol compliance. 
   
• Adhere