Intern, Site Operations

Javara•Fayetteville, GA

About The Position

Essential Duties and Responsibilities: Promote the mission of Javara with a primary guiding principle of patient safety and well-being and building and maintaining a culture that combines the highest standard of integrity with excellence to all those Javara serves. Assist CTN and CTN Assistant with processing study deliveries including data entry and database maintenance, updating site specific data and applicable records. Shadow Clinical Trial Navigator (CTN) during study visits. May assist with clinical related tasks such as processing and packaging lab specimens; may draw blood. May assist with study visits such as copying the Intermediate Care Facility (ICF) for the research participant and/or processing labs. Operate with the safety and protection of clinical trial participants as a primary responsibility. Complete all required training including: Conflict of Interest, Good Clinical Practice, Human Subject Protection, HIPAA privacy and security; components of a study protocol; other study specific processes such as obtaining and processing laboratory specimens, shipping biological materials, study drug accountability, or other study specific need. Complete training on Adverse Events (AEs)/Serious Adverse Events (SAEs) and demonstrate understanding in completion of familiarization project. Research and gather documentation on areas of interest in clinical research as well as information related to Javara’s healthcare partners. Complete detailed review of Javara’s Standard Operating Procedures, ICF Process, as well as Demographic, Medical History, and Concomitant Medication Forms; discuss with Supervisor. Complete training or review instructions on any designated task prior to performing that task. Review study protocols for which the Intern will assist, to be determined by the research team. Assist in preparing information and research materials for site meetings; attend and document notes during meetings, type documents, drafts and reports as well as maintain and organize documents; update calendars or SharePoint, as needed. Answer phones and run errands, as needed. Attend company functions and networking events as well as teleconferences and webinars. Comply with any College/University internship requirements, if applicable. Qualifications: Required Currently enrolled in an accredited 2- or 4-year college or a recent 4-year college graduate. Highly proficient with Microsoft Office applications, specifically with word processing software. Excellent written and verbal communication skills. Strong time management and organizational skills. Ability to maintain a high degree of confidentiality. High initiative with ability to work autonomously or as part of a team. 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. Javara is an integrated research organization (IRO) that advances value by integrating clinical research within the healthcare ecosystem. Javara brings better outcomes for patient centered care, better economic results, improved access to cutting edge therapies and a more predictable research delivery model to the biopharmaceutical sector. Equal Employment Opportunity Statement: Javara provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We're thrilled that you're considering joining #TeamJavara. Our team is passionate about breaking barriers to make a true difference in the world and address unmet needs of patients through clinical research as a care option. Javara is dedicated to fostering a culture of teamwork and collaboration while embracing and celebrating diversity. Whether you're a seasoned professional or just starting to explore clinical research as a career, you will have the opportunity to be part of cutting-edge research that has the potential to shape the future. Join us in our pursuit of excellence as we unlock new insights, solve complex challenges, and drive positive change for both our patients and trusted healthcare partners. Your journey towards a fulfilling career in clinical research starts here. Javara is an integrated research organization (IRO) that advances value by integrating clinical research within the healthcare ecosystem. Javara brings better outcomes for patient centered care, better economic results, improved access to cutting edge therapies and a more predictable research delivery model to the biopharmaceutical sector.

Requirements

Currently enrolled in an accredited 2- or 4-year college or a recent 4-year college graduate.
Highly proficient with Microsoft Office applications, specifically with word processing software.
Excellent written and verbal communication skills.
Strong time management and organizational skills.
Ability to maintain a high degree of confidentiality.
High initiative with ability to work autonomously or as part of a team.

Responsibilities

Promote the mission of Javara with a primary guiding principle of patient safety and well-being and building and maintaining a culture that combines the highest standard of integrity with excellence to all those Javara serves.
Assist CTN and CTN Assistant with processing study deliveries including data entry and database maintenance, updating site specific data and applicable records.
Shadow Clinical Trial Navigator (CTN) during study visits.
May assist with clinical related tasks such as processing and packaging lab specimens; may draw blood.
May assist with study visits such as copying the Intermediate Care Facility (ICF) for the research participant and/or processing labs.
Operate with the safety and protection of clinical trial participants as a primary responsibility.
Complete all required training including: Conflict of Interest, Good Clinical Practice, Human Subject Protection, HIPAA privacy and security; components of a study protocol; other study specific processes such as obtaining and processing laboratory specimens, shipping biological materials, study drug accountability, or other study specific need.
Complete training on Adverse Events (AEs)/Serious Adverse Events (SAEs) and demonstrate understanding in completion of familiarization project.
Research and gather documentation on areas of interest in clinical research as well as information related to Javara’s healthcare partners.
Complete detailed review of Javara’s Standard Operating Procedures, ICF Process, as well as Demographic, Medical History, and Concomitant Medication Forms; discuss with Supervisor.
Complete training or review instructions on any designated task prior to performing that task.
Review study protocols for which the Intern will assist, to be determined by the research team.
Assist in preparing information and research materials for site meetings; attend and document notes during meetings, type documents, drafts and reports as well as maintain and organize documents; update calendars or SharePoint, as needed.
Answer phones and run errands, as needed.
Attend company functions and networking events as well as teleconferences and webinars.
Comply with any College/University internship requirements, if applicable.