Study Monitor
2 months ago
Element has a current opening for a Study Monitor to join our growing team *on-site* in Colorado. Our Study Monitor will assist the Quality Manager in the review of completed clinical studies, help ensure that study binders include all necessary paperwork and that data was collected within protocol requirements, follow organizational guidelines and standard operating procedures per the quality management system.
The pay range for the job is set between $25.00-$40.00 per hour, and will heavily depend on level of related or direct experience.
Responsibilities:
Reviews clinical trial investigations for completeness of documentation for submission
Clinical Investigation Plans, Informed Consents, Instructions for Use, Risk Assessment documentation. Generates missing documentation as needed or works with Study Coordinator to complete
Oversees the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
Monitors study documentation
Confirms Informed consent process is used.
Reviews Case Report Forms for accuracy and completeness based on the source documentation.
Identifies missing documents in the research study binder
Generates regulatory documentation based on ISO14155, “Clinical investigation of medical devices for human subjects — Good clinical practice” for research study binder (Trial Master File)
Generation and/or maintenance of study documentation including protocols, informed consents, source documentation, case report forms, reports, subject enrollment logs, site & visit / monitoring logs, training logs, delegation of authority, device accountability, financial disclosure, RESUME’s / resumes & licensure and other trial master file documents.
Assists GLP (Good Laboratory Practice) Quality Audits
Assists Lab organization and training
Maintains current compliance on CITI training for Good Clinical Practice of Clinical Investigations for Devices
Monitors other staff CITI (Collaborative Institutional Training Initiative) training expiration / renewal dates for compliance
Maintains Blood Borne Pathogen compliance
Monitors DORA (Department of Regulatory Agencies) for licensure and expiration for licensed staff and clinicians
Interface with and act as a liaison to sponsors and study coordinators for Clinimark monitoring.
Assist with generation of Monitoring procedures.
Skills / Qualifications:
Degree preferred but not required.
Proficiency in Microsoft Applications (Word, Excel, PowerPoint, Outlook)
Availability, flexibility, and maturity to represent the company at a broad range of events/projects in the community, with customers and within the company
Well-developed oral and written communication skills to meet a variety of communication needs, Good interpersonal skills that foster open upward and downward communication built on mutual respect
Technical background is a plus
Ability to interface with clients
Attention to detail is an absolute must
Proficiency with Microsoft Office
Possession of good communication skills (verbal, written)
Possession of independent, problem-solving abilities
Knowledge and compliance with laboratory procedures, quality and safety requirements
Strong Organizational and Scheduling Skills
#LI-TK1
Company Overview:
Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to ‘Make tomorrow safer than today’.
When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.
While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.
Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.
Diversity Statement:
At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.
All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
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