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Clinical Research Coordinator/Sleep Lab Manager

Company: Icon Government and Public Health Solutions
Location: Silver Spring
Posted on: October 10, 2019

Job Description:

ESSENTIAL FUNCTIONS:

Oversee/manage technical staff in the conduction of new protocols investigating effects of sleep, sleep loss and pharmacological agents, including investigational new drugs, on cognitive/physiological performance, physiology, efficacy, and safety.

Study schedule management - i.e., develop and maintain the schedule for use of the sleep laboratory facilities so as to optimize efficient conduction of multiple concurrent studies, taking into consideration the study priorities provided by the Chief of the Department of Behavioral Biology, WRAIR, and the optimal use of both human and material resource required to conduct these studies.

Protocol Coordination:

*

Oversee, organize, and prioritize all activities associated with conducting studies within a military setting investigating effects of drugs, including investigational new drugs, and/or sleep loss on cognitive/physiological performance; alertness, mood, and recovery sleep; and implements protocols investigating sleep stage-related changes in brain activity (e.g., as measured by PET and/or fMRI).
*

Review and understand protocol, ensuring applicable regulations, and guidelines are followed.
*

Oversee preparation of subjects (attach electrodes, etc.,) and calibrate psychophysiological recording equipment for evoked potential, sleep recording, EKG etc. sessions.
*

Oversee monitoring of psychophysiological/physiological equipment as data are recorded on-line.
*

Oversee and score of sleep stages, and compile/enter sleep, performance, and mood data for statistical analyses.
*

Oversee and administer psychological and performance measures to subjects as specified in protocols
*

Oversee and assist in collecting physiological data (e.g., metabolic rate) and aid in their compilation/entry for later analyses.
*

Oversee and recruit volunteers for the studies, to include determining volunteer population availability, advertising venues, and discussions with potential volunteers via telephone or e-mail.
*

Volunteer advocate and associated duties.
*

Test article accountability.
*

Documentation, to include gathering, preparing and maintaining appropriate information per applicable FDA regulations and ICH guidelines, source and case report forms, participant rosters, SOPs, etc.
*

Enter required data on CRFs and audit records for accuracy, resolve discrepancies, correct as necessary.
*

Coordinate with external and internal monitors; additionally maintain compliance with specific protocol, SOPs, regulations, and guidelines.
*

Computer literate to create forms, reports, etc.
*

Coordinate space and supplies with appropriate personnel.
*

Other duties as assigned

Provide technical assistance to CRM Headquarters as needed and participate on proposal writing projects when requested.

* Provide all job-related progress reports/technical reports as requested

* 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.

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.

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

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, Silver Spring , Clinical Research Coordinator/Sleep Lab Manager, Executive , Silver Spring, Maryland

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