U.S. Renal Care
Clinical Research Coordinator San Antonio
U.S. Renal Care, San Antonio, Texas, United States, 78208
Clinical Research Coordinator
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Clinical Research Coordinator
role at
U.S. Renal Care
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 are directed by the PI. 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.
Ensure and document that the informed consent process has occurred properly.
Assist in the process of maintaining and updating each study participant's source records.
Promptly report adverse events, protocol deviations and unanticipated problems.
Ensure thorough, individualized, protocol-based study subject education on all study processes.
Provide timely and accurate exchange of participant information with the PI and research team.
Adhere to HIPAA Privacy Rule and protect participant confidentiality.
Dispense, administer and instruct participants on proper use of the investigational product (IP).
Collaborate with the USRC clinical team and ensure compliance with the study protocol.
Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor CRFs/IWRS.
Aid in the coordination of long‑term storage of research records.
Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory inspections.
Maintain essential documents (The Trial Master File) and assist in coordination of industry partners and CROs for efficient trial selection and patient recruitment.
Foster a patient‑care culture that emphasizes patient safety and quality.
Travel to investigator meetings or related research meetings is required, including travel between dialysis facilities or nephrology practices within the community.
Develop a working knowledge of current clinical research practice standards and regulatory requirements.
May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.
Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.
Regular and reliable attendance is required for the job.
Qualifications
Bachelor's degree in related field preferred.
One to three 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.
Intermediate computer skills including Microsoft Office and proficiency in USRC applications required within 90 days of hire.
Benefits
Medical / Pharmacy
Dental
Vision
Voluntary benefits
401(k) with employer match
Virtual Care
Life Insurance
Paid Time Off (PTO)
Equal Opportunity Employer. All qualified applicants, regardless of race, color, religion, national origin, sex, gender identity, sexual orientation, age, disability, or veteran status, are encouraged to apply.
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Clinical Research Coordinator
role at
U.S. Renal Care
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 are directed by the PI. 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.
Ensure and document that the informed consent process has occurred properly.
Assist in the process of maintaining and updating each study participant's source records.
Promptly report adverse events, protocol deviations and unanticipated problems.
Ensure thorough, individualized, protocol-based study subject education on all study processes.
Provide timely and accurate exchange of participant information with the PI and research team.
Adhere to HIPAA Privacy Rule and protect participant confidentiality.
Dispense, administer and instruct participants on proper use of the investigational product (IP).
Collaborate with the USRC clinical team and ensure compliance with the study protocol.
Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor CRFs/IWRS.
Aid in the coordination of long‑term storage of research records.
Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory inspections.
Maintain essential documents (The Trial Master File) and assist in coordination of industry partners and CROs for efficient trial selection and patient recruitment.
Foster a patient‑care culture that emphasizes patient safety and quality.
Travel to investigator meetings or related research meetings is required, including travel between dialysis facilities or nephrology practices within the community.
Develop a working knowledge of current clinical research practice standards and regulatory requirements.
May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.
Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.
Regular and reliable attendance is required for the job.
Qualifications
Bachelor's degree in related field preferred.
One to three 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.
Intermediate computer skills including Microsoft Office and proficiency in USRC applications required within 90 days of hire.
Benefits
Medical / Pharmacy
Dental
Vision
Voluntary benefits
401(k) with employer match
Virtual Care
Life Insurance
Paid Time Off (PTO)
Equal Opportunity Employer. All qualified applicants, regardless of race, color, religion, national origin, sex, gender identity, sexual orientation, age, disability, or veteran status, are encouraged to apply.
#J-18808-Ljbffr