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At WellNow Urgent Care, we are dedicated to delivering quality healthcare to our Urgent Care patients and Occupational Health clients. As a WellNow Provider, you will be part of a team that is committed to improving the delivery of care and supporting your growth as a medical professional. Join us in providing exceptional healthcare services and making a difference in our communities.
The Clinical Research and Quality Coordinator- (CRQC) is responsible for coordinating the compliance of clinical research trials, ensuring regulatory compliance with Good Clinical Practice and International Conference on Harmonization Guidelines, FDA Guidance, research SOPs, financial regulations, and any requirements stipulated by the study sponsor while ensuring the safety and welfare of all study participants. The CRQC communicates with the principal investigator, research team and sponsors & CROs to ensure efficient trial start up and quality execution. The CRQC ensures billing data, regulatory and program compliance are maintained at all times.
Essential Job FunctionsEnsure compliance with multiple assigned trials and successfully conduct all protocols in accordance with FDA, GCP and ICH guidelines and research SOPs. Coordinates the implementation and conduct of research requirements by submitting documents for sponsor and IRB approval, maintenance of regulatory documents and communication of changes to the research team. Maintain a good working knowledge of research protocols assigned. Ensure all trial materials are available and IRB & Sponsor approval received in a timely manner to facilitate study start up. Recruit and screen potential study participants according to study timelines while working closely with the Investigator to ensure proper enrollment through understanding of inclusion and exclusion criteria and protocol requirements Properly consent participants in accordance within FDA, GCP and protocol specified guidelines Accurately record all Adverse Events, Serious Adverse Events and ensure timely acknowledgement and review by Investigator and reporting to the sponsor & IRB as applicable. Collect accurate and complete data for each assigned clinical research trial, successful and timely resolution of queries from Sponsor and/or CRO. Assist with preparation and response for audits as necessary. Develop and maintain tools to conduct the study accurately and efficiently. Assist with study participant visits for each trial, which may\ include, but are not limited to, performing electrocardiograms, collecting vital signs, collecting and processing laboratory samples, POC and other testing as required and assisting with examinations as necessary. Effectively communicate with sponsors/CROs concerning all aspects of study activities. Maintain professional relationships including frequent and open communication with all clients. Serve as a liaison between investigators, research personnel, outside trial personnel and leadership to assist in protocol interpretation, enrollment and safety adherence. Utilize computer software applications such as Clinical Conductor (CTMS) and sponsor software programs to enhance workflow and trial efficiencies. Review CTMS daily for trial management and financial accountability. Participate in sponsor visits associated with the trial including Investigator Meetings (remote and in person; occasional travel required). Develop and maintain long-term client relationships to ensure repeat business. Provide excellent customer service to all parties involved in the clinical trial process. Market the research program to local private physician practices. Determine the most effective Sub investigator-based recruitment plan for the site and adjust hours to maximize subject visits. Maintain a current knowledge of the FDA Code of Federal Regulations, DHHS regulations, and other research-speciific entities. Travel to sites as necessary to back up site Clinical Research Coordinators. Other responsibilities as identified by management.
Additional Job Description
WellNow is an EOE
Additional Job Description
Employer's Disclaimer:
All requirements are subject to possible modification to reasonably accommodate individuals with disabilities.
This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.
The company reserves the right to add to or revise an employee's job duties at any time at its sole discretion.
This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.
Physical Activities and Requirements:
Ability to sit, stand, walk, use hands to finger, grasp, handle or feel, reach, stoop, kneel, crouch, or bend, climb, talk, hear, and perform repetitive motions of hands and/or wrists.
Requires some physical work; lifting, pushing, or pulling required of objects up to 50 lbs
Mental and Visual Requirements:
Works in clean, smoke-free and well-lighted spaces.
Exposure to frequent deadlines/ must have ability to handle stress effectively, subject to frequent interruptions
Must have good visual and hearing acuity.
Must be able to utilize keyboard and view computer screens up to 90% of time
Must be able to follow directions and plan fairly complex processes & workflow
Required License or Certification:
CCRC, CCRA, or CRCP preferred
Education:
Bachelor’s, CMA or comparable work experience
Minimum Job Qualifications:
2+ years clinical trial experience
Ability to self-direct and work independently and in a complex team environment
Strong interpersonal skills and communication skills and the ability to interact with staff at all levels
Ability to succeed in changing environment and handle multiple competing priorities
Demonstrated ability to foster concepts of teamwork
Ability to problem solve and facilitate consensus in a group environment
Ability to establish and maintain successful relationships with potential sponsors, CROs and investigators
Ability to work as a member of a diverse team, as well as an independent agent of change
Knowledge of clinical research including the critical elements for the development and execution of clinical trials or research studies
Ability to think critically
Ability to handle stress
Strong skills in prioritization, organization, problem-solving, decision-making, time management, mentoring, planning, facilitating consensus and detail oriented
Excellent written and verbal communication skills
Computer skills including Microsoft PowerPoint, Word, Excel, and Outlook
Ability to travel to sites, meetings and conferences as needed (local travel ~25%; out of town travel
WellNow is an EOE.
WellNow, is part of TAG-The Aspen Group's family of healthcare brands.
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Seniority level
Entry level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Hospitals and Health Care
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