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.
ESSENTIAL FUNCTIONS:
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.
Supervises all ICON GPHS Department of Clinical Trials (DCT) contract employees.
Acts as a mentor; conducts training, counsels and performs annual evaluations for CRC staff and the support staff supervisor.
Assesses staff and investigator compliance with FDA and Army regulations, and Good Clinical Practice (GCP) guidelines.
Tracks credentials and training requirements.
Reviews clinical research protocols in order to plan staffing needs.
Pre-reviews incoming clinical protocols for compliance and logistical issues.
Schedules incoming protocols for space and staffing; assign CRCs, storage of study product and specimens as required, overlap of study requirements related to staff and study volunteer flow through the clinic.
Oversees the DCT calendar to ensure optimal planning and execution of clinical research protocols.
Liaison with other study personnel outside of the DCT, including but not limited to study sponsors, clinical research monitors and research laboratory staff.
Works closely with ICON GPHS TMB Liaison and Program management to ensure necessary subcontract and business agreements are procured for study execution.
Schedules and assist in monthly DCT Staff meeting, attend the monthly Translational Medicine Branch (TMB) meeting, facilitate site initiation visits (SIV) and walkthroughs for incoming protocols.
Reviews, revises and approves standard operating procedures (SOP) as appropriate.
Assigns staff to SOP review and creation.
Manages Emergency cart assignments, and resupply.
Assists or conducts VIP tours of the Clinical Trials Center (CTC).
Functions in any role within the DCT, to include but not limited to CRC, phlebotomist, recruiter, and administrative assistant.
Provides technical assistance to ICON GPHS Headquarters as needed and participates on proposal writing projects when requested.
Provides all job-related progress reports/technical reports as requested.
Approves timesheets and leave requests for all CTC ICON GPHS staff.
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.
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.
WORK ENVIRONMENT:
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.
Qualifications
ExperienceAdvanced Cardiac Life Support (ACLS) certification encouraged. (preferred) Must be able to work independently following a brief period of specific technical training. (preferred) Ability to establish and maintain effective working relationships with coworkers, managers and customers (preferred) Maintain Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA). (preferred) Basic Life Support (BLS -CPR/ AED) certification. (preferred) Knowledge of applicable highly complex scientific procedures and techniques relating to position. (preferred) 5 years: Clinical Research experience (required) Licenses & CertificationsRN (required)
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. 41 CFR 60-1.35(c)
