Clinical Research Coordinator

U.S. Renal Care, Inc.•San Antonio, TX

About The Position

The Clinical Research Coordinator (CRC) coordinates daily clinical trial activities in partnership with the principal investigator (PI) and the PI’s physician practice. The PI provides local oversight and direction for clinical research activities. The CRC works collaboratively with the PI, Sr. Clinical Research Coordinator, clinical site, sponsors, CROs, IRBs, and study participants to conduct trials in accordance with the study protocol, FDA and ICH requirements, and applicable state and local regulations, while assisting the PI in protecting participants’ rights, safety, and welfare. The role includes coordinating participant care from screening through study completion; maintaining source records and essential trial documents; educating participants; collecting and entering study data; and supporting recruitment, enrollment, trial implementation, monitoring, audits, and inspections. The CRC also supports research quality assurance, participant stipend processing, long-term records storage, and collaboration with internal and external research partners. Travel to research-related meetings and between community dialysis facilities or nephrology practices may be required. The CRC may train and oversee other coordinators or research assistants.

Requirements

One to three years of clinical research experience required.
Basic knowledge of FDA regulations, IRB requirements, and Good Clinical Practice.
Strong verbal and written communication skills.
Intermediate computer skills, including Microsoft Word, Excel, Outlook, and web-based tools.
Proficiency in USRC applications required within 90 days of hire.
Ability to perform the essential duties satisfactorily.
Maintain industry-standard licenses and certifications.

Nice To Haves

Bachelor’s degree in a related field preferred.
Nephrology experience preferred.
Basic knowledge of kidney care, End-Stage Kidney Disease (ESKD), or a similar field is a plus.

Responsibilities

Coordinate participant care from screening through study completion according to the protocol and PI delegation.
Ensure and document that informed consent is conducted properly in accordance with 45 CFR Part 46.
Maintain and update participant source records, including medical history, eligibility assessments, study procedures, and relevant information.
Promptly report adverse events, protocol deviations, and unanticipated problems involving risk to the PI, sponsor, and IRB, in accordance with applicable regulations.
Provide individualized, protocol-based participant education about consent, study obligations, investigational product use, side effects and safety, communication with study staff, and research rights.
Exchange participant information with the PI and research team in a timely and accurate manner to support study conduct and patient safety.
Protect participant confidentiality and comply with HIPAA Privacy Rule requirements.
Dispense and administer investigational products and instruct participants in their proper use, according to the protocol, scope of practice, and PI direction.
Collaborate with the USRC clinical team on trial implementation and support clinical partners’ compliance with study protocols.
Collect and document data accurately and promptly; enter data into USRC databases, sponsor CRFs, and IWRS; and respond to queries and sponsor requests.
Assist with coordinating long-term storage of research records in accordance with contractual requirements and direction from the Director of Clinical Research.
Assist with preparation for and attendance at site initiation meetings, monitoring visits, audits, and regulatory inspections.
Prepare and maintain essential trial documents and the Trial Master File, including applicable regulatory, IRB, study, delegation, enrollment, and monitoring documents.
Coordinate internal and external resources to support trial selection, patient recruitment, enrollment goals, and trial execution.
Promote a patient-care culture emphasizing safety and quality.
Register participants in the stipend payment system, process payments according to USRC policy, and maintain payment records during the trial.
Follow USRC research quality assurance program guidelines.
Travel to investigator meetings or similar research-related meetings and, as required, between community dialysis facilities or nephrology practices.
Develop working knowledge of clinical research standards and regulatory requirements, and maintain industry-standard licenses and certifications.
May train and oversee Clinical Research Coordinators and/or Research Assistants.
Promote GUEST customer service standards and develop effective relationships across the organization.
Participate in team activities and staff meetings as required, and perform duties in accordance with company policies and procedures.
Maintain regular and reliable attendance.