Clinical Research Coordinator
Company: WellNow Urgent Care
Posted on: May 13, 2022
Director, Research Site Operations
The Clinical Research Coordinator (CRC) is responsible for
coordinating all aspects of clinical research trials, ensuring
regulatory compliance with Good Clinical Practice and International
Conference on Harmonization Guidelines, FDA Guidance, research SOPs
and any requirements stipulated by the study sponsor while ensuring
the safety and welfare of all study participants. The CRC
communicates with the principal investigator, research team and
sponsors & CROs to ensure efficient trial start up and quality
execution. The CRC ensures confidentiality and compliance are
maintained at all times.
ESSENTIAL JOB FUNCTIONS:
Ensure 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
Maintain a good working knowledge of research protocols
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.
Schedule and oversee all trial visits for participants on assigned
protocols while adhering to the protocol specified timelines.
- Collect accurate and complete data for each clinical research
trial, including preparation and review of source documents and
case report forms. Ensure that all required documentation,
including source documents and case report forms, has been
accurately and successfully completed and appropriately filed and
uploaded to the Sponsor and/or CRO. 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
Coordinate and manage study participant visits for each trial.
Responsibilities 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.
Train other site personnel and urgent care staff in understanding
and implementation of assigned protocols.
Utilize computer software applications such as Clinical Conductor
(CTMS) and sponsor software programs to enhance workflow and trial
efficiencies. Update CTMS daily for trial management and financial
Participate in sponsor visits associated with the trial including
Investigator Meetings (remote and in person; occasional travel
Develop and maintain long-term client relationships to ensure
Provide excellent customer service to all parties involved in the
clinical trial process.
Other responsibilities as identified by management.
MINIMUM JOB QUALIFICATIONS:
2+ years clinical trial experience
Ability to self-direct and work independently and in a complex team
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
Demonstrated ability to foster concepts of teamwork
Ability to problem solve and facilitate consensus in a group
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
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
Ability to travel to sites, meetings and conferences as needed
(local travel -25%; out of town travel
Bachelor's, CMA or comparable work experience
REQUIRED LICENSE OR CERTIFICATION
CCRC or CRCP preferred
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
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
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
Keywords: WellNow Urgent Care, Lorain , Clinical Research Coordinator, Healthcare , Lorain, Ohio
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