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 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.
• 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 efficiently.
• 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 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.
• 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 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 < 5%)

EDUCATION:

• 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.

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

Job Type: Part-time

Pay: From $28.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Experience:

• Clinical Trial: 2 years (Required)

Work Location: One location

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