Clinical Research Coordinator
Company: Icon Government and Public Health Solutions
Posted on: October 12, 2019
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
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
* 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
* 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
* 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
* 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
* 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
* 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
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
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
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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