Clinical Research Coordinator

Panoramic Health•Providence, RI

12d•Onsite

About The Position

Nephrology Associates, Inc. is seeking an experienced Clinical Research Coordinator to join its clinical research team in Providence, Rhode Island. The role coordinates day-to-day, site-level execution of clinical research studies and works closely with investigators, physicians, clinic staff, patients, sponsors, and the broader research team. It focuses on patient recruitment and enrollment, study execution, regulatory and protocol compliance, data quality, and patient safety. The coordinator manages multiple studies and a high volume of patients while maintaining accuracy and quality. The coordinator supports study start-up and site readiness, identifies and enrolls participants, coordinates protocol-specific visits and procedures, maintains study data and documentation, and supports monitoring and quality oversight. The position also coordinates site resources and collaborates with clinic and research stakeholders to address operational challenges. It offers ownership of study execution and exposure to site-level research operations focused on kidney disease care.

Requirements

3–5 years of clinical research experience, preferably in a coordinator role with increasing responsibility.
Strong knowledge of medical terminology and clinical research practices.
Working knowledge of GCP, IATA, FDA regulations, and research compliance requirements.
Demonstrated ability to manage multiple studies and a high volume of patients while maintaining quality and attention to detail.
Ability to perform basic clinical procedures, including blood draws, vital signs, height, and weight.
Ability to perform ECGs.
Excellent organizational, interpersonal, written, and verbal communication skills.
Ability to independently drive recruitment, enrollment, data quality, and study execution.
Strong attention to detail and commitment to patient safety and research quality.
Ability to multitask, prioritize competing responsibilities, and work effectively in a fast-paced clinical environment.

Nice To Haves

Bachelor's degree in a health-related field preferred.
Medical Assistant (MA) certification preferred.
Good Clinical Practice (GCP) and/or IATA certification preferred.
ACRP or SOCRA certification preferred.
Experience in CKD, nephrology, vascular access, or a related therapeutic area is a plus.
Bilingual English/Spanish skills preferred.

Responsibilities

Read, understand, and operationalize assigned research protocols and study requirements.
Prescreen patients and identify potentially eligible research participants.
Train site staff on study purpose, procedures, and requirements, and maintain training documentation.
Evaluate study resources and coordinate with clinic leadership to prepare the site for study execution.
Develop and implement workflows to improve recruitment, enrollment, patient flow, and study operations.
Identify and recruit potentially eligible patients in collaboration with physicians, clinic staff, and the research team.
Communicate study eligibility criteria and research opportunities to referring physicians and clinic staff.
Partner with the Central Research team, including the Central Enrollment Team, to meet or exceed referral, consent, and enrollment targets.
Obtain and document informed consent in accordance with ICH/GCP, protocol requirements, and site SOPs.
Promote a positive patient experience while prioritizing patient safety and ethical research practices.
Coordinate and plan subject visits according to protocol-specific schedules and requirements.
Ensure visits and procedures are completed within protocol-defined windows and minimize protocol deviations.
Perform basic clinical procedures, including vital signs, height, weight, blood collection, and ECGs.
Collect, process, and ship laboratory specimens according to protocol requirements.
Dispense and collect investigational product or medication and maintain accurate accountability records.
Monitor patient participation and maintain accurate patient tracking documentation.
Complete case report forms, electronic data capture systems, and other study documentation accurately and on time.
Maintain data integrity in accordance with ALCOA principles and ensure data are collected according to protocol-specific requirements.
Report adverse events and serious adverse events to the appropriate IRB, sponsor, and management within required timelines.
Maintain accurate study files, logs, source documentation, and patient records.
Prepare for and support sponsor/CRO monitoring visits; ensure source documents are organized, complete, and readily available.
Respond to monitor follow-up letters promptly and resolve outstanding items.
Maintain current temperature logs, investigational product accountability records, and other required study documentation.
Resolve data queries and outstanding action items promptly.
Maintain compliance with study protocols, site SOPs, ICH/GCP, IATA, FDA regulations, and applicable research requirements.
Coordinate with location administration to ensure appropriate space, equipment, supplies, and other resources are available for study activities.
Build working relationships with physicians, clinic staff, patients, sponsors, CROs, and internal research teams.
Identify operational challenges and proactively implement solutions to improve study performance.
Perform other duties and responsibilities as assigned.