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Clinical Research Coordinator

Company: Icon Government and Public Health Solutions
Location: Portsmouth
Posted on: October 12, 2019

Job 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. Protocols will include both pediatric and adult patients, animals and human anatomical specimens (including cadavers). The specific protocol(s) requiring CRC support shall be determined by the Department Head of CID.

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

* Support to the Department Head of CID and the PIs of each protocol in accordance with written policies and procedures as set forth in Title 21 of the Code of Federal Regulations, NMCP, and Bureau of Medicine & Surgery (BUMED) instructions

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

* Administer and collect questionnaires from patients and healthcare providers at study sites.

* Observe patient care teams and complete teamwork questionnaires at local study sites.

* Assign appropriate subject identification number per protocol design.

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

* 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.

* 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.

* In collaboration with CID, PIs, and assigned medical monitor, prepare reports and other correspondence regarding the research protocol for the IRB, granting agencies, industry sponsors, and other organizations as required by regulation and/or the protocol.

* In collaboration with key research personnel and investigators, process and prepare specimens for lab analysis and shipping.

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

* Attend local conferences (approved by the COR) and other meetings as required by the protocol, the PI, or the sponsoring agency.

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

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

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.

EqualOpportunityEmployerDescription

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

PayTransparencyPolicyStatement

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.

Keywords: Icon Government and Public Health Solutions, Portsmouth , Clinical Research Coordinator, Healthcare , Portsmouth, Virginia

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