Contract Clinical Research Coordinator

1 week ago

Lincoln, United States Medix™ Full time

Contract Clinical Research Coordinator - Lincoln Nebraska


This is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites.


Summary:


The Clinical Research Coordinator conducts and manages clinical trials in accordance with the study protocol, GCP, and SOPs.


Duties/Responsibilities:

  • Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and SOPs
  • Coordinate, with supervision, assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing, and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.
  • Implement research and administrative strategies to successfully manage assigned protocols.
  • Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
  • Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems, and resolving queries
  • Maintain confidentiality of patient protected health information, sponsor confidential information and confidential information
  • Ensure patient safety is upheld and all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and SOPs.
  • Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner
  • Ensure staff are delegated and trained appropriately and documented
  • Create, collect, and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements.
  • Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.
  • Execute recruitment strategies defined by Clinical Research Team
  • Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
  • Perform clinical duties (e.g. drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope
  • Promote respect for cultural diversity and conventions with all individuals.


Education/Experience:

  • Bachelor’s degree with 1 year of relevant experience in the life science industry OR
  • Associate’s degree with 2 years of relevant experience in the life science industry OR
  • High School Graduate and/or technical degre with minimum of 3 years relevant experience in the life science industry


Required Licenses/Certifications:

  • Pharmacy Technician license/certification
  • Phlebotomy experience is a plus


Required Skills:

  • Demonstrated knowledge of medical terminology
  • Demonstrated ability in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
  • Demonstrated ability to work in a fast-paced environment
  • Demonstrated verbal, written, and organizational skills
  • Demonstrated interpersonal and communication skills
  • Demonstrated ability to work as a team player
  • Demonstrated ability to read, write, and speak English
  • Demonstrated ability to multi-task
  • Demonstrated ability to follow written guidelines
  • Demonstrated ability to work independently, plan and prioritize with some guidance
  • Demonstrated ability to be flexible/adapt as daily schedule may change rapidly
  • Must be detail oriented
  • Demonstrated problem solving and strategic decision making ability.
  • Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued and/or praised.

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