What are the responsibilities and job description for the Clinical Affairs Monitor - Contract (Part Time) position at Reva Medical LLC?
Summary of Essential Duties and Responsibilities
The primary function of this role will be to provide monitoring services in support of REVA Clinical Studies :
Conduct site monitoring visits in accordance with applicable Code of Federal Regulations, Good Clinical Practice guidelines and REVA internal plans and work instructions.
Review and ensure timely and accurate entry of Case Report Form (CRF) data into REVA's electronic data capture system (EDC) is completed by site personnel per clinical study requirements.
Generate, track and resolve queries in EDC system as needed to clarify or ensure complete data entry by sites.
Ensure timely and accurate site-reporting of protocol-defined adverse events. Assist in collecting adverse event subject data such as deidentified source documents for distribution to Core Labs, Clinical Event Committees and Data Safety Monitoring Boards as needed.
Ensure all study-related images are collected and transmitted in proper format to Core Labs for analysis. Maintain accurate records for assessing image counts.
Maintain frequent communication with investigators and site staff to ensure subjects are scheduled for in-window follow-up visits and imaging.
Review device accountability records, ensuring device integrity is maintained ( i.e ., limited access, temperature control and expiration dates).
Ensure complete and audit-ready Trial Master File essential documents are collected, filed and maintained for assigned sites.
Ensure clinical study supplies are distributed to sites ( e.g., study binders, case report forms, and misc. materials).
Support study start-up and close-out phases as needed, including Institutional Review Board regulatory filing.
Assist in the organization and execution of Investigator and Study Coordinator meetings.
Education and / or Experience
College graduate or equivalent with a minimum of 2-5 years on-site and remote monitoring experience
Required Knowledge / Skills
Proficient with basic computer programs such as Microsoft Word, Microsoft Excel and Microsoft PowerPoint.
Detail oriented in document review and error checking
Familiarity with clinical trial regulatory requirements and investigational device control
Effective communication skills
Physical Demands / Working Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to sit or stand for prolonged periods of time, frequently in front of a computer. This position requires travel approximately 50%.
Hours may flex from 30-40 a week depending on study load
Salary : $70 - $100
