Study Manager (strong, Policy-driven, Organized Leader)
Novum Pharmaceutical Research Services, Inc. (Las Vegas, Nevada)

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Looking to get into the Medical Research industry?

Novum PRS is looking for LPNs, Paramedic or RNs with Lead or Supervisory experience to help manage our Research Studies!  Novum PRS performs research studies to bring Generic Drugs to the market.  You must be a strong, policy-driven, organized supervisor.

Starting Pay: $23.42 per hour. Work schedule includes weekends

Study Manager

Department: Clinic

Position Summary

Coordinate and oversee all aspects necessary for clinical study progression, according to the study protocol and Standard Operating Procedures (SOP’s).

Essential Responsibilities

·        Work with source document staff on development and QC of study specific documents.

·        Coordinate initiation meeting with all pertinent staff e.g., Recruiting, Screening, Source Documentation, Maintenance, Pharmacy, Quality Assurance, etc. prior to study start.

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

·        Consult with Pharmacy Technician for drug handling, dispensing, dosing time and dosing intervals.

·        Meet with maintenance staff regarding clinic set-up to ensure all routine and special needs (e.g., EKG tables, extra phlebotomy stations) are accounted for.

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

·        Work with Screening Department to ensure participants meet all eligibility criteria.

·        Participate in dosing of study participants.

·        Record any adverse events (AE) and discuss with Investigator as appropriate. For each study period prepare adverse event summary for Client Services.

·        Hire, Schedule, Supervise and discipline (as necessary) all Research Associates, Technicians and Phlebotomists assigned to the study. Communicate all staff issues to management for appropriate follow up.

·        Orient and train new staff as applicable.

·        Conduct and coordinate check-in procedures for study.

·        Ensure that all other support services are accounted for (e.g., all supplies are available and meals have been ordered).

·        Verify documentation of all study activities.

·        Assign case report form completion to appropriate staff.

·        QC all case report forms for accuracy within specified time frame.

·        Compute participant payments based on completed study participation.

·        Follow-up on participants who have open adverse events and/or need repeat laboratory tests after study completion.

·        Communicate pertinent study observations or problems to the Principal Investigator and management.

·        Complete tables for final report.

·        Cross-train for other departments as needed.

·        Other duties as assigned.

Qualifications

·        Associate’s Degree in Nursing or equivalent, or Nursing qualification (LPN or RN).  At least 3 years work experience in a medical or clinical research setting.

·        One year of supervisory/management experience. Strong leadership/management skills will be responsible for directly supervising clinical staff and study participants.

·        Ability to prioritize projects and work schedules to ensure timely completion of projects.

·        Very high attention to detail and follow up.

·        Strong organizational skills.

·        Excellent communication skills both written and verbal.

·        Prefer previous research experience.

·        Flexible work schedules, able to work 10-12 hour shifts, evenings and regular weekends as needed.

Licensing/Certification Requirements

·        Valid and current nursing license (if required).

·        Current CPR certification required.

If you are an energetic self confident individual looking for a tremendous opportunity please send resume and salary requirements to  arbosheth@novumprs.com  or fax them to 702-921-6353 Please feel free to take a look at our web site Novumprs.com for more information. EOE.  ***Local Candidates Only*** 

Starting Pay: $23.42 per hour. Work schedule includes weekends