Clinical Research Coordinator II (On-Site)

Job Description

Job Description

As a Clinical Trial Navigator II with Javara, you will be responsible for the coordination and administration of clinical trials and report to the Manager of Site Operations and the Principal Investigator or designee. You will be a critical member of our organization and contribute to patient enrollment efforts within a variety of clinical trials. With a guiding principle of research participant safety, you will implement and coordinate research study procedures for the successful management of clinical trials.

Essential Responsibilities

• Seek to improve the patient’s experience, never compromising on safety.
• Provide excellent customer service to patients and participants, healthcare partner and practice stat investigators, sponsors, and vendors.
• Operate as the lead Clinical Trial Navigator for multiple clinical studies, dependent upon site-specific study needs such as study complexity and enrollment goal volume, by owning the enrollment plan and strategies to achieve and exceed expectations. May serve as a lead CTN across Javara for a single study, providing support and guidance to other assigned CTNs.
• Execute the enrollment plan of assigned studies to meet requirement goals by identifying and contacting potential participants and screening to enroll into suitable studies.
• Support enrollment goals by contributing to patient retention strategies and building relationships within local communities.
• Participate in developing creative approaches to patient recruitment and retention strategies, including participating in community engagement.
• Ensure scientific integrity of data and record source data appropriately and accurately inclusive of patient visit data within source, CTMS, electronic reporting systems, completing the sponsor’s case report form, and timely query resolution.
• Ensure study documentation is up to date and audit ready, including reporting of adverse events and deviations with investigational products.
• Adhere to all Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), protocols, OSHA, proper PPE usage and other regulatory authority requirements.
• Conduct and document the informed consent process.
• Inform and educate the research team and healthcare system staff regarding study related procedures including IP dosing and monitoring requirements.
• Coordinate and schedule patient visits and conduct visits per protocols.

Qualifications:

· Associates or Bachelor’s Degree in related field or equivalent industry experience.

· 2+ years of experience in clinical research that includes hands-on application of clinical functions such as obtaining vitals, EKGs, and phlebotomy.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

· This job operates in a professional environment.

· The noise level in this work environment is usually light to moderate.

Physical Demands:

The physical demands described here are representative of those that must be met to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

· The employee will regularly use hands to reach, handle or feel objects, tools, or controls and talk and hear.

· The employee may frequently stand, walk and sit.

· The employee may occasionally lift and/or move up to 25 pounds.

· Specific vision abilities required include close vision, distance vision and the ability to adjust focus.

Pre-Employment Screening: Drug screen and background check required.

This job description covers the most essential functions of this position and is not designed to contain a comprehensive listing of activities, duties or responsibilities that are required of the employee in this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Type: Full-time

Pay: From $62,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Retirement plan
• Vision insurance

Experience:

• Clinical research: 1 year (Required)

License/Certification:

• Certified Medical Assistant (Required)

Work Location: In person