Clinical Research Coordinator

OUR PURPOSE

Founded in 1999, Mills Clinical Research does cutting-edge research with a special focus on infectious diseases, vaccine trials, and men’s health.  We have locations in the West Hollywood and South LA.  Mills Clinical Research is led by Dr. Anthony Mills as the PI and CEO. We are affiliated with Men’s Health Foundation and have expansive community networks within Southern California.  We share the mission to eliminate health inequity for all, especially those at risk.

THE POSITION

The Clinical Research Coordinator will work under the guidance of the Principal Investigator, Sub-Investigators, and/or Director/Manager of Clinical Research Operations to participate in the planning, implementation, and overall direction of clinical research projects conducted on behalf of the sponsors at the institute. You will perform study procedures, transcribe source data to case report forms, and liaise with sponsor personnel, maintaining a high level of professional expertise through familiarity with the study protocol, investigator’s brochure, related study materials, standard operating procedures and policies, and participation in project team meetings. Ensuring research quality by practicing compliance and following the principles of Good Clinical Practice (GCP)/International Harmonization Conference (ICH), Health Insurance Portability and Accountability Act (HIPAA), Federal Drug Administration (FDA) policies and guidelines, and other applicable regulations (state and local).

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: (This list may not include all of the duties assigned.)

•  Applying knowledge of study design and flow chart to evaluate protocol feasibility at the research site and developing strategy for implementing study procedures in compliance with study protocol.
• Preparing and submitting documents to institutional review board, attending and participating in investigator meetings as directed, and initiating query requests to sponsors for the study.
• Recruiting and screening research participants to evaluate eligibility for a clinical study by reviewing medical record source documents, inclusion/exclusion criteria, and participants’ willingness and capability to follow required clinical research procedures, processes, and follow up appointments.
• Obtaining informed consent documentation from research participants prior to any study-related procedures, maintaining patient screening enrollment logs, and following randomization procedures per protocol, ensuring protection of patients' confidentiality and privacy during initial and follow-up interviews and visits.
• Dispensing study drugs per protocol, reviewing participants' diaries and questionnaires as appropriate, and collecting, batching, and shipping specimens as required.
• Adhering to HIPAA requirements when transmitting data via fax, mail, or electronically as requested by the sponsor or CRO, and resolving data queries and maintaining files for all study related documentation.
• Completing and maintaining all study drug accountability records, including drug dispensing and returned drug compliance and findings.
• Completing all required data entry and attending to query resolutions in the allotted time per sponsor, protocol, FDA and GCP guidelines.
• Contacting primary care providers to discuss and inform patient enrollment and study progress as directed, and meeting regularly with investigator and research team to discuss participant participation and protocol progress.
• Providing timely notification to the investigator, sponsor and IRB of adverse events as outlined in the protocol. 
• Scheduling sponsor monitoring visits as directed by the Director of Clinical Research Operations, preparing case report forms and collecting source documents for sponsor / audit review. 
• Meeting with research team during routine visits to discuss case report form completion, query resolution and other protocol-related issues and preparing for and participating in FDA inspections.
• Schedule participants for follow-up visits and assess participants' compliance with the test drugs on follow-up visits. You must be able to recognize and report abnormal laboratory values, and, if adverse events occur, you must collect and document this information for evaluation by the investigator. In addition, you will document protocol deviations and exemptions by obtaining and reviewing original source documents (e.g. recordings, scans, tests, and procedure results). As a Clinical Research Coordinator, you will abstract data from medical records, clinic, consultation, and referral notes to study forms and flow sheets; record data onto case report forms; and maintain source documentation for all case report entries. 
• Other duties may be assigned, as required.