About The Position

Coordinates and collaborates with the Pharmacist in providing support of clinical investigational drug trials; provides accurate and efficient dispensing of medication and performs cross-functional duties as required. May act as a resource to other staff with pharmacy-related questions.

Requirements

  • Must be a Licensed Practical Nurse or Licensed Vocational Nurse with a current license in the state in which the employee will be working.
  • Phlebotomy Experience (Required)
  • Must be capable of performing all clinical tasks relevant to licensure and/or training.
  • Must be able to clearly communicate verbally with patients.
  • Must have good interpersonal skills, demonstrated through interactions with patients, staff, Sponsor representatives, etc.
  • Must be self-motivated and able to perform tasks independently.
  • Ability to react calmly and effectively in emergencies.
  • Must reflect the professional image of the company, upholding the company vision in actions and demeanor.

Responsibilities

  • Provides general nursing care to study participants as necessary; including, but not limited to monitoring of vitals, blood sugar, vital signs, lab tests, etc.
  • Reads and understands all study protocol and pharmacy manual requirements regarding the management of study drug and pharmacy related tasks.
  • Completes and maintains study documents in accordance with sponsor and site requirements.
  • Possible recruitment of potential study subjects.
  • Screens subjects for eligibility and schedules subjects for study-specific assessments, as designated on the Delegation of Authority Log.
  • Completes and maintains Case Report Forms in agreement with the source documentation and in accordance with the study protocol.
  • Accompanies sponsor representatives during their visits and maintains effective and ongoing communication with the sponsor.
  • Maintains adequate inventory of all data and supplies.
  • Regularly attends training meetings, staff meetings, initiation meetings, study start-up meetings, and other meetings as assigned.
  • Observes, documents, reports, and follows up on adverse events and serious adverse events.
  • Conducts the informed consent process, per CenExel Standard Operating Procedures.
  • Follows up appropriately on all laboratory results.
  • Maintains safety standards when performing job responsibilities.
  • Maintains study logs and site relations
  • Ensures proper collection, processing, and shipment (if applicable) of laboratory specimens.
  • Is on call to answer questions for other members of support staff, study patients or other medical staff, as necessary.
  • Assists with quality assurance activities and completes queries, as applicable.
  • Obtains Principal Investigator signatures on necessary documents.
  • Oversees or coordinates the administration of investigational medication and follows subjects throughout the study stay, per protocol.
  • Ensures accountability and adequate supply for study and clinical drugs.
  • Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
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