Intern, Site Operations

Javara•Charlotte, NC

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.

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

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.
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.
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.