As a Clinical Research Coordinator/Clinical Trial Navigator I 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 at least one clinical study by owning the enrollment plan and strategies to achieve and exceed expectations.Execute the enrollment plan of assigned studies to meet requirement goals by identifying and contacting potential participants and screening to enroll into suitable studies.Build effective working relationships with colleagues, patients, investigators, and other internal and external partners on clinical trials.Support enrollment goals by contributing to patient retention strategies and building relationships within local communities.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.Appropriately communicate and escalate to support responsiveness and resolution with our healthcare partners and other external stakeholders.Perform clinical and laboratory skills such as therapeutic area specifics, obtaining vitals, phlebotomy, EKGs, and collecting, processing, and shipping bodily samples.Demonstrate thoughtfulness around the immediate impact of your role on clinical trials.Demonstrate our Core Values such as fostering teamwork and collaboration and cultivating relationships with healthcare system representatives.Additional tasks as assigned.Qualifications:
Associates or Bachelor’s Degree in related field or equivalent industry experience.1+ years’ experience in healthcare or a related field 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.Travel: This position may require up to 20% travel regionally but may occasionally include travel to other regions or Javara headquarters in Winston-Salem, NC.
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.
Read LessAs a Clinical Trial Navigator I 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 at least one clinical study by owning the enrollment plan and strategies to achieve and exceed expectations.Execute the enrollment plan of assigned studies to meet requirement goals by identifying and contacting potential participants and screening to enroll into suitable studies.Build effective working relationships with colleagues, patients, investigators, and other internal and external partners on clinical trials.Support enrollment goals by contributing to patient retention strategies and building relationships within local communities.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.Appropriately communicate and escalate to support responsiveness and resolution with our healthcare partners and other external stakeholders.Perform clinical and laboratory skills such as therapeutic area specifics, obtaining vitals, phlebotomy, EKGs, and collecting, processing, and shipping bodily samples.Demonstrate thoughtfulness around the immediate impact of your role on clinical trials.Demonstrate our Core Values such as fostering teamwork and collaboration and cultivating relationships with healthcare system representatives.Additional tasks as assigned.Qualifications:
Associates or Bachelor’s Degree in related field or equivalent industry experience.1+ years’ experience in healthcare or a related field 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.Travel: This position may require up to 30% travel regionally but may occasionally include travel to other regions or Javara headquarters in Winston-Salem, NC.
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 Description
As the Manager, Site Operations, you will be responsible for comprehensive operational and relationship management of clinical trial activities associated with our healthcare partnerships. With a guiding principle of research participant safety, you will promote the mission, vision, and values of Javara and ensure the strategic integrity of the relationship between our teams and the healthcare organization. You will demonstrate leadership capabilities and consistently demonstrate high-quality and results-oriented performance. You will be on-site daily and report to the regional Director, Site Operations and lead clinical teams across multiple locations with multiple therapeutic areas of research with multi-specialty, inpatient and outpatient trials.
Essential Responsibilities:
Qualifications:
2+ years’ experience managing a clinical research site and team or equivalent relevant management experience.5+ years’ of clinical trial research experience including hands-on application of clinical functions such as obtaining vitals, EKG’s, and phlebotomy.Associates or Bachelors Degree or equivalent educational experience. Degree in Life Sciences or related field highly beneficial.Experience applying leadership approaches such as situational leadership, servant leadership, and transformational leadership for people management.Experience using business acumen to develop strategies to achieve and exceed expected results.Project ManagementWork 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.Travel: This position may involve up to 20% travel with most travel within their region, as well as applicable visits to Javara headquarters in Winston Salem, NC.
Pre-Employment Screening: Drug screen and background check required.
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