U.S. Renal Care
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 CRC will work collaboratively with the 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, FDA, ICH and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants.
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 45 CFR part 46.
Assist in 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 to the PI, the Sponsor, the IRB and in accordance with 21 CFR 312.
Ensure thorough, individualized, protocol-based study subject education on all study processes including informed consent, study participation obligations, appropriate use of investigational product (IP) side effects and safety.
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 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 and participate in trial implementation to ensure compliance with the study protocol by our clinical partners.
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 (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.
Assist in the coordination of internal and external resources to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution.
Foster a patient‑care culture that emphasizes patient safety and quality in all aspects.
Responsible for 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.
Adhere 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.
Develop a working knowledge of current clinical research practice standards and regulatory requirements. For example, FDA GCP, HIPAA, IATA shipping of dangerous goods and maintain industry standard licensures and certifications.
May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.
Actively promote 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.
Qualifications / Requirements
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.
Benefits All full‑time employees are eligible for the following benefits: Medical / Pharmacy, Dental, Vision, Voluntary benefits, 401 k with employer match, Virtual Care, Life Insurance, Voluntary Benefits, PTO.
All part‑time employees are eligible for the following benefits: 401 k with employer match, PTO.
Employment Information Seniority level: Entry level.
Employment type: Full‑time.
Job function: Research, Analyst, and Information Technology.
Industry: Hospitals and Health Care.
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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 45 CFR part 46.
Assist in 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 to the PI, the Sponsor, the IRB and in accordance with 21 CFR 312.
Ensure thorough, individualized, protocol-based study subject education on all study processes including informed consent, study participation obligations, appropriate use of investigational product (IP) side effects and safety.
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 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 and participate in trial implementation to ensure compliance with the study protocol by our clinical partners.
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 (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.
Assist in the coordination of internal and external resources to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution.
Foster a patient‑care culture that emphasizes patient safety and quality in all aspects.
Responsible for 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.
Adhere 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.
Develop a working knowledge of current clinical research practice standards and regulatory requirements. For example, FDA GCP, HIPAA, IATA shipping of dangerous goods and maintain industry standard licensures and certifications.
May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.
Actively promote 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.
Qualifications / Requirements
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.
Benefits All full‑time employees are eligible for the following benefits: Medical / Pharmacy, Dental, Vision, Voluntary benefits, 401 k with employer match, Virtual Care, Life Insurance, Voluntary Benefits, PTO.
All part‑time employees are eligible for the following benefits: 401 k with employer match, PTO.
Employment Information Seniority level: Entry level.
Employment type: Full‑time.
Job function: Research, Analyst, and Information Technology.
Industry: Hospitals and Health Care.
#J-18808-Ljbffr