Doctor-Medical Practitioner (Clinical Trials)

omaha, Nebraska

Our client is seeking a Doctor/Medical Practitioner (Clinical Trials) to join their team in Omaha, Nebraska. 

This is a Full Time/Direct Hire role, but with hourly rate pay.

Responsibilities

  • Conducts all clinical trials (studies) according to ICH GCP, local regulations, study protocol and company processes.
  • Ensures the medical wellbeing and safety of the participants through the safe performance and execution of the studies.
  • Drives clinical oversight and quality of the studies at site, or with PI oversight at other sites.
  • Proactively participates and engages in driving delivery of study targets, thereby contributing to the commercial success of the site, which includes recruitment, enrolment and retention of study participants.
  • Manages and oversees studies simultaneously with the responsibility of PI and sub-I.
  • Carries out clinical evaluation and assessment of participants to ensure eligible participants are recruited and monitored for safety and adherence.
  • Attends Site Initiation Visits (SIV), Pre-Selections Visits (PSV) and Investigator meetings as required.
  • Participates in recruitment initiatives and strategy development to ensure targets are achieved; ensuring recruiting studies enroll according to plan within timelines and targets.
  • Reviews enrolment progress, pre-screening and screening success rates, screen failure rates, safety and retention of participants.
  • Interprets protocols and IB.
  • Manages and reviews IVRS, CRF/EDC, if applicable.
  • Oversees management of investigational medical product (IMP).
  • Oversees multiple studies and/or studies with higher numbers.
  • Completes documentation for PI handover.
  • Cares for and protects the safety of participants through ethical conduct; this should receive the highest priority at all times during all aspects of the study.
  • Fulfills and complies with all medical duties, ensuring that clinical trials are performed to acceptable medical, scientific and ethical standards and meet the requirements as per protocol, SOP/COP ICH and local GCP guidelines and regulations.

Supervision Received:

  • Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead).
  • Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.

Business Relationships:

  • Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts.
  • Creates formal networks with key contacts outside own area of expertise.

Working Conditions and Environment:

  • Work is performed in an office environment with exposure to electrical office equipment.
  • Occasional travel.

Qualifications

  • A valid medical degree within the country of practice with at least 2 years working as a licensed physician
  • Valid registration as a medical practitioner, with a medical license in good standing and with unrestricted ability to practice in place of work, where applicable
  • A valid ICH GCP certificate
  • At least one year of experience working in clinical research with the added advantage of PI responsibility experience, but at least Sub-I experience
  • Exceptional general medical practitioner diagnosis and treatment proficiency
  • In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
  • Thorough understanding of medical terminology, drug safety, and interpretation of lab reports
  • Working knowledge of scientific concepts related to the design and analysis of clinical trials
  • Thorough critical thinking, decision making, analytical and problem-solving skills
  • Exceptional communication skills and ability to work with a cross-functional team to drive results
  • Demonstrated ability to influence and collaborate at all levels throughout the organization
  • Excellent written, verbal and presentation skills
  • Capable of working well under pressure
  • Capable of effectively prioritizing and managing multiple projects
  • Strong planning, organizational and project management skills
  • Capable of managing outside agencies in order to fulfill project objectives
  • Self-starter with ability to thrive under pressure in a fast-paced environment
  • Skilled in Word, Excel, and PowerPoint and proficient with the Internet

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