Clinical Research Coordinator (Non-certified)
Clinical Research Management - Silver Spring, MD

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Growing and well-respected biomedical (clinical, basic and applied) research firm has openings at WRAIR . If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team.

We are currently seeking a Clinical Research Coordinator (Non-certified) for the Silver Spring, Maryland area.

RESPONSIBILITIES:

  • Protocol Coordination:

  • Organize and prioritize all activities associated with conducting laboratory- and field-based human use protocols.

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

  • The contractor would ensure before the study begins that there is space available for the volunteers to conduct the study and supplies available from the stock pile within behavioral biology .

  • Recruit volunteers for protocols, to include determining volunteer population availability, advertising venues, and discussions with potential volunteers via telephone or e-mail.

  • Test article accountability to include consultation with Pharmacy Technician and PI for drug handling, dispensing, dosing time and dosing intervals.

  • 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.

  • As an RN, provides clinical expertise/knowledge to other staff in the department.

  • Monitor volunteer safety, compliance and health status as needed and follows through with the appropriate physician.

  • Review clinic schedule for adequate staff coverage of all protocol activities and communicate any concerns to Lab Manager.

  • Review sample collection and processing instructions with Phlebotomists to ensure all requirements are followed.

  • Participate in dosing of study participants.

  • Prepare adverse event summary.

  • Prepare deviations log.

  • Communicate pertinent study observations to the Principal Investigator (and management).

  • Complete CRRs and final reports for review by the PI.

  • Provide assistance to Behavioral Biology Branch as needed on proposal writing projects and provide assistance with all job-related progress reports/technical reports.

  • Maintain a safe work place 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.

  • MINIMUM QUALIFICATIONS:

  • Registered nurse licensed in state of Maryland.

  • Minimum 3 years work experience in clinical research setting as research coordinator

  • Strong leadership/management skills - will be responsible for directing research staff and study participants

  • CCRC certification is REQUIRED-or have the ability to get certified within 6 months of hire.

  • Able to work both independently and in a team setting.

  • Excellent communication, organization and prioritization skills.

  • Intermittent physical activity including bending, reaching and prolonged periods of sitting and or standing.

  • May be required to work at different collaborating facilities (e.g., NIH, NiCoE) and be responsible for own transportation.

  • Must be available to be scheduled based on operational and business needs (to include overnights and weekends during study execution).

  • Required Knowledge, Skills and Abilities: knowledge of applicable highly complex scientific procedures and techniques relating to position. Background in polysomnography is a plus.

  • Physical Capabilities: work may involve long periods of standing, interacting with research volunteers, and handling of chemicals and/or hazardous biological material 12. Work Environment: laboratory environment primary; may also include hospital (e.g., NIH, NiCoE) environment; will require working evenings and weekends; some shifts may be greater than 8 hours in duration.

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

  • Must be a US Citizen or Permanent resident to apply.

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

  • Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.

    ClinicalRM is an Affirmative Action-Equal Opportunity Employer

    www.clinicalrm.com

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    Clinical Research Management - 12 months ago - save job
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