Clinical Research Coordinator - Toledo, OH
Company: U.S. Renal Care
Location: Lambertville
Posted on: March 14, 2026
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Job Description:
SUMMARY The Clinical Research Coordinator (CRC) is responsible
for the coordination of daily clinical trial activities. USRC has a
research Partnership with the principal investigator (PI) and their
physician practice. The local oversight and direction for
activities related to the conduct of the clinical research is
directed by the PI. The CRC will work collaboratively with the
principal investigator (PI), the Sr. Clinical Research Coordinator
(SCRC), the clinical site, sponsor(s), clinical research
organization(s) (CROs), institutional review boards (IRBs), and
study participants to ensure Execution of the clinical trial in
accordance with the Study Protocol, the Food and Drug
Administration (FDA), International Council for Harmonization of
Technical Requirements for Pharmaceuticals for Human Use (ICH) and
applicable state and local regulations. The CRC will assist the PI
in protecting the rights, safety and welfare of all study
participants. Essential Duties and Responsibilities include the
following. Other duties and tasks may be assigned. Coordinate all
aspects of participant care from screening through study completion
as defined by the protocol and PI delegation. Ensure and document
that the informed consent process has occurred properly according
to the Code of Federal Regulations (45 CFR part 46). Assist in the
process of maintaining and updating each study participant's source
records, including collection of medical history, assessment of
eligibility and documentation of all study related procedures and
relevant information. Promptly report adverse events, protocol
deviations and unanticipated problems involving risk to human
subjects or others to the PI, the Sponsor, the IRB and in
accordance with the Federal Code of Regulations (21 CFR 312), with
assistance as applicable. Ensure thorough, individualized,
protocol-based study subject education on all study processes
including but not limited to informed consent, study participation
obligations, appropriate use of investigational product (IP), IP
side effects and safety, communication with study staff and
research rights. Provide timely and accurate exchange of
participant information with the PI and research team as it
pertains to study conduct and patient safety. Adhere to the Health
Insurance Portability and Accountability Act (HIPAA Privacy Rule)
and protect participant confidentiality at all times. Dispense,
administer and instruct participants on proper use of the
investigational product (IP) in accordance with the protocol,
coordinator's scope of practice and at the direction of the PI,
with assistance as needed. Collaborate with the USRC clinical team.
Participate in trial implementation, and ensure compliance with the
study protocol by our clinical partners, with assistance as needed.
Perform accurate and timely data collection, source documentation,
and entry into the USRC databases and sponsor Case Report Forms
(CRFs)/ interactive web response systems (IWRS). Address queries
and sponsor requests in a timely manner. Aid in the coordination of
long-term storage of research records in accordance with
contractual requirements, with direction from the Director of
Clinical Research. Assist in the preparation of and attendance
during site initiation meetings, monitoring visits, audit visits or
regulatory authority inspections. Responsible for the preparation
and ongoing maintenance of Essential Documents (The Trial Master
File). This includes those documents that will allow for the
evaluation of the clinical trial and demonstrate compliance of the
sponsor and PI with the study protocol and GCP. (Including but not
limited to: Form FDA 1572, financial disclosures, laboratory
certifications, protocol, investigator brochure, institutional
review board (IRB) related documents, IND reports delegation of
authority (DOA), study specific enrollment logs, monitoring
reports, with assistance as needed. Assists in the coordination of
efforts of internal and external resources (industry partners,
clinical research organizations) to ensure efficient trial
selection, proper patient recruitment, achieving target enrollment
goals and trial plan execution. Fosters a patient-care culture that
emphasizes patient safety and quality in all aspects. Responsible
for the patient stipend automated payment process including
registration into the system and processing payments per the USRC
policy and ongoing maintenance of payments during the trial.
Adheres to the USRC Research quality assurance program guidelines.
Travel to Investigator Meetings or similar research related
meetings is required. Travel may be required between dialysis
facilities or nephrology practices within the community. Develops a
working knowledge of current clinical research practice standards
and regulatory requirements. For example, but not limited to; (FDA
Federal Code of Regulations Good Clinical Practice (GCP), Health
Insurance Portability and Accountability Act (HIPPA), International
Air and Transportation Association (IATA) - Shipping of Dangerous
Goods. Maintains their industry standard licensures and
certifications. May provide training and oversight of Clinical
Research Coordinators and/or Research Assistants. Actively promotes
GUEST customer service standards; develop effective relationships
at all levels of the organization. Participate in team concepts and
promote a team effort; perform duties in accordance with company
policies and procedures. Participate in staff meetings as required.
Regular and reliable attendance is required for the job. Actively
promotes GUEST customer service standards; develops effective
relationships at all levels of the organization. Participates in
team concepts and promote a team effort; performs duties in
accordance with company policies and procedures. Regular and
reliable attendance is required for the job.
Qualifications/Requirements: To perform this job successfully, an
individual must be able to perform each essential duty
satisfactorily. Requirements include: Bachelor's degree in related
field preferred. One (1) to three (3) years of experience in
clinical research required; nephrology experience preferred. Basic
knowledge of FDA regulations, IRB requirements and Good Clinical
Practice. Basic knowledge of kidney care and/or End-Stage Kidney
Disease (ESKD) or similar field is a plus. Strong verbal and
written communication skills required. Must have intermediate
computer skills, including Microsoft Office (Word, Excel, Outlook
and web based tools); proficiency in USRC applications required
within 90 days of hire. All Full Time employees are eligible for
the following benefits: * Medical / Pharmacy * Dental * Vision *
Voluntary benefits * 401k with employer match * Virtual Care * Life
Insurance * Voluntary Benefits * PTO All Part Time employees are
eligible for the following benefits: * 401k with employer match *
PTO
Keywords: U.S. Renal Care, Parma , Clinical Research Coordinator - Toledo, OH, Science, Research & Development , Lambertville, Ohio
