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Clinical Research Sub-Investigator - Nurse Practitioner or Physician Assistant

Waco, TX

Details

Hiring Company

Impact Research Institute

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Position Description

JOB TITLE: Nurse Practitioner, Physician Assistant; Sub-Investigator DEPARTMENT: Research
STATUS: Part-time; may include occasional Saturdays
REPORTS TO: Site Manager

POSITION SUMMARY:

Unique opportunity to join a clinical trial research team in the field of Hepatology and other disease states as a Sub Investigator. The Sub Investigator works closely with the Principal Investigator to oversee the execution of study protocols, working closely together with Clinical Research Team, and ensuring site compliance with study protocols, study-specific laboratory procedures, standards of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), quality (QA/QC) procedures, and other state and local regulations as applicable.

JOB DUTIES:

  • Performs all job responsibilities in accordance with standards of Good Clinical Practice

  • Possesses a working knowledge of GCP/ICH guidelines, Clinic SOPs, QA/QC procedures

  • Reviews Investigator's Brochure prior to performing any study related activities

  • Ensures informed consent has been obtained prior to performing any study procedures

  • Performs all study responsibilities in compliance with the IRB approved protocol

  • Reviews screening documentation and approves subjects for admission to study

  • Reviews admission documentation and approves subject for randomization

  • Overseas patient Recruitment and Retention

  • Participates in Marketing and Business Development meetings

  • Ensures patients are enrolled within agreed Sponsor timelines

  • Documents all findings in subject specific source documents

  • Provides ongoing assessment of the study patient to identify Adverse Events

  • Ensures proper documentation and reporting of all Adverse Events and Serious Adverse Events

  • Reviews and evaluates all study data and comments to the clinical significance of any out-of-range

    results/ Procedures

  • Performs physical examinations and dietary Counseling as part of screening evaluation and active

    study conduct

  • Provides medical management of adverse events as appropriate

  • Completes all study documentation in accordance with the study specific requirements

  • Communicates with Sponsors, monitors and auditors as requested

  • Monitors safety and well-being of participants at all times

  • Provides coverage for the Clinic Principal Investigator

• Other Duties as assigned EDUCATION & EXPERIENCE

JOB DESCRIPTION

  • Licensed Nurse Practitioners in Texas or Licensed Physician Assistant in Texas

  • Minimum two years of experience in current License

  • CPR Certified

  • Ability to follow GCP guidelines and pass Certification

  • Ability to understand Research terms and work closely with research Team for Subject Safety

  • Capable and willing to perform both Clinical duties and Research duties

    QUALIFICATIONS & REQUIREMENTS

  • A can-do attitude and character of eagerness and willingness to accept and meet challenges to ensure success

  • Able to effectively present information and respond to questions from physicians, staff and patients

  • Able to read, analyze, and interpret information from professional journals, technical procedures, or

    governmental regulations

  • Able to function effectively in a team setting

  • Excellent time management skills

  • Able to identify, interpret, and act within protocol requirements for patients’ safety

  • Responsibility for studies and duties assigned

  • Needs to demonstrate consistent professional conduct and meticulous attention to detail

  • Must possess excellent verbal and written communication skills as well as excellent interpersonal

    skills with patients, staff, and other health care professionals

  • 3 work related references

    Impact Research Institute is an Equal Opportunity Employer IMPACTRESEARCHTX.COM


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