ICON Government and Public Health Solutions specializes in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with a wide array of research, regulatory, and sponsor services both within the US and around the globe and respond rapidly to global health crises.
Reasonable Accommodation Statement:
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
Provides GCP and project training to site staff.
Assists in development of associated study documents (Safety Monitoring Plans, Manual of Operations and Informed Consents).
Identifies site issues/problems, and associated root causes, and develops action plans to ensure resolution, including escalation of appropriate issues in a timely manner.
Acts as the main line of communication between the site and project manager.
Leads study start up team as needed. Provides support and acts as primary point of contact for collection and review of site essential documents.
Manages study sites to ensure site compliance with study protocols, GGP/ICH, and applicable regulations.
Conducts monitoring visits (Qualification, Site Initiation, Interim, Close-out, Audit Prep).
Generates clinical monitoring reports and follow up letters in a timely manner.
Verifies that all research staff and facilities have adequate qualifications and resources and are maintained throughout the course of the clinical study.
Verifies that the investigator and research staff follow the approved protocol and all GCP procedures.
Ensures adverse events, concomitant medications, and inter-current illnesses are reported in accordance with the protocol on the CRF.
Communicates deviations from the protocol, SOPs, GCP, and applicable regulatory requirements to the investigator and ensures corrective action is implemented.
Reviews queries and assists in resolution.
Utilizes CTMS to generate, review and provide study reports.
Assists with setup, quality and maintenance of the Trial Master Files (TMF) in accordance with ClinicalRM SOPs, Good Clinical Practice (GCP), ICH guidelines and federal regulations.
Participates in project team meetings.
Assists the Project Management team in preparation for audits or inspections.
Works with the Project Managers to ensure all the required study documentation (agreements, site SOPs, etc) have been obtained from the site prior to site initiation.
Participates in the department review and update of SOPs when needed.
Assists with protocol development and review as needed.
Maintains a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
Performs light duties and other related duties as required and assigned.
Candidates for positions under ICON Government and Public Health Solutions contracts with the Department of Defense (DoD) may be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency.
[List Minimum education, years of experience, skills, clearance and citizenship requirements. Use bullets instead of numbers.]
WORKING CONDITIONS/PHYSICAL DEMANDS:
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.
5 year(s): Clinical Research experience.
2 year(s): Experience as CRA, performing site visits.
Strong interpersonal and communication skills, good problem-solving skills and ability and willingness to travel 75-80% of the time.
Able to manage multiple tasks simultaneously.
Must be able to work independently following a brief period of specific technical training.
Bachelors or better in Nursing or related field
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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.