Job Description:

Description

DETAILED DESCRIPTION

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.

- Coordinate the research activities of IRB-approved study protocols.

- Participate in the design, administration, and monitoring of clinical trials.

- Provide protocol development support services, including development of clinical protocols and protocol-related documents (including but not limited to subject recruitment and marketing plan, clinical trial master file, Informed Consent Form (ICF), Case Report Form (CRF), clinical study reports, protocol amendments, Continuing Review reports, etc.

- Support and conduct research in conjunction with the PIs of the assigned IRB-approved protocols.

- Recruit and screen subjects using protocol inclusion/exclusion criteria.

- Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented.

- Assist with the preparation of study-related materials and instructions.

- Input research data into database.

- Report adverse events to the IRB-protocol PI for submission to governing agencies and sponsors as required by protocol and regulations.

- Evaluate compliance of research subject to protocols and complete documentation of status and progress.

- Conduct telephone or face-to-face interviews and mail government approved information for follow-up visits.

- Respond to research participants in an efficient and timely manner and documents interactions appropriately.

- Support the development of regulatory documentation including editing, formatting, submission, and approvals.

- Maintain detailed documentation of the research study including but not limited to individual patient files, databases as required by the protocol and the Investigator's File Binder/Regulatory Binder.

- Interact on a regular basis with the PI regarding the conduct of the research study.

- Observe safety regulations when working in ambulatory care spaces and inpatient wards (such as the use of personal protective equipment (PPE)

- 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.

Experience

- Required Knowledge, Skills and Abilities; knowledge of applicable highly complex scientific procedures and techniques relating to position.

- Physical Capabilities: work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material.

- Must be able to work independently following a brief period of specific technical training.

- 2-3 years:Candidate must have direct research experience

Preferred

- Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) preferred, or commitment to sit for exam during first year of employment.

- Basic Life Support (BLS -CPR/AED) certification.

- Work Environment: laboratory environment; may require working evenings and weekends.

- Incumbent will be scheduled based on operational and business needs.

- Incumbent may be required to work at any facility and be responsible for own transportation

- Registered nurse licensed in state of Maryland

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.

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).

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