Lead Clinical Research Associate 6/13/2019
Icon Government and Public Health Solutions
JOB DESCRIPTIONAPPLY ICON Government and Public Health Solutions specializing 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 an array of research, regulatory, and sponsor services. Globally, we respond rapidly to health crises and serve where few others do. We create a unique synergy in the global market, with projects spanning the government, academic, and commercial sectors. ICON Government and Public Health Solutions has a distinct ability to provide rapid response efforts 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.
* Actively participates in multiple internal cross functional teams to ensure the delivery of assigned project milestones.
* Assists Clinical Project Managers in project coordination, planning and logistics, including overview of budgets and timelines as needed.
* Participates in project team meetings.
* Assists the Project Managers with the follow up and resolution of action items, risk mitigation and Corrective and Preventative Action plans.
* Works with the Project Managers to select qualified and experienced research sites. This includes feasibility questionnaire generation, site outreach, tracking of feedback and overall review of site responses/qualifications.
* Provides training to CRAs (Basic orientation, CTMS, Protocol Specific).
* Provides daily oversight of CRAs including co-monitoring for assessment and evaluation.
* Develops clinical monitoring plans and assist in development of associated study documents (Safety Monitoring Plans, Manual of Operations and Informed Consents).
* Assists CRAs and QA specialist in identification of site issues/problems, and associated root causes, and development action plans to ensure resolution, including escalation of appropriate issues in a timely manner.
* Acts as the main line of communication between the sponsor and the CRA.
* Reviews and approves monitoring reports and follow up letters.
* Provides management of study sites to ensure site compliance with study protocols, GGP/ICH, and applicable regulations.
* Conducts monitoring visits as needed (Qualification, Site Initiation, Interim, Close-out, Audit Prep.)
* 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 ensure corrective action is implemented.
* Reviews queries and assist 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 to Clinical RM SOPs, Good Clinical Practice (GCP), ICH guidelines and federal regulations.
* Assists with the selection, communication and maintenance of project related vendors.
* Performs ongoing reviews of the TMF to ensure quality of the documentation files and compliance with Clinical RM SOPs, GCP and ICH guidelines.
* 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 of SOPs when needed.
* Assists with protocol development and review as needed.
* Provides technical assistance for proposal writing as needed.
* Reviews Safety and Clinical Study Reports.
* 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.
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.
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)