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U.S. Renal Care · 2 days ago

Clinical Research Coordinator - Toledo, OH

Toledo, OH

Full-time

Onsite

Entry, Mid Level

1+ years exp

U.S. Renal Care is a company focused on providing quality care in the field of nephrology. The Clinical Research Coordinator (CRC) will coordinate daily clinical trial activities, ensuring compliance with study protocols and regulatory requirements while protecting the rights and safety of study participants.

BiotechnologyHealth CareMedical

Responsibilities

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

Qualification

Clinical research experienceFDA regulations knowledgeClinical Practice (GCP)Nephrology experienceComputer skillsMicrosoft Office proficiencyCommunication skillsTeam collaboration

Required

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

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