Clinical Research Coordinator

22 hours ago

Tucson, United States Tucson Clinical Research Institute LLC Full time
Job DescriptionJob Description

Looking to join a team where you are valued and can make an impact? Tucson Clinical Research Institute LLC is offering the opportunity to join our team of passionate and dedicated staff.

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.

Essential Duties and Responsibilities:

  • Assisting trial Investigator in screening and review of potential study participants eligibility
  • Performs clinical duties as required, including but not limited to medical histories, consenting, electrocardiograms, pulmonary function tests, psychological assessments, subcutaneous injections, vital signs, phlebotomy, specimen processing, laboratory testing, pharmacy dispensation, patient education.
  • Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events within 24 hrs. Follow-up with the subject and collaborate information as needed.
  • Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program.
  • Ensures uniform implementation of protocols by completing required training documentation in a consistent, accurate and timely manner.
  • Assists in regulatory functions, including but not limited to preparing appropriate Institutional Review Board (IRB) forms, processing updated informed consents, protocols, correspondence, and regulatory filing in an accurate and timely manner.
  • Responsible for administrative duties including filing documents related to subjects participation in research, regulatory, lab results, receipts, invoices, calibration reports, etc.
  • Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards.
  • Provides all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum.
  • Maintaining case report forms, charts and documentation
  • Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants
  • Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements
  • Collecting and entering data as necessary and Query Resolution
  • Assist with study start-up, maintenance, and close-out of studies as needed for those on the team
  • Tracking study supply inventory and reordering when necessary
  • Schedule patient visits in appropriate electronic systems
  • Ability to be flexible with study assignments
  • Knowledge of all active protocols and disease indications within the company, and providing information about these protocols to staff and patients.

Qualifications

  • Clinical skills, including the ability to perform phlebotomy
  • Extensive clinical trial knowledge through education and/or experience
  • Successful completion of GCP Certification and Advanced CRC preferred
  • Minimum 1-2 years of clinical research coordinator experience required
  • Excellent communication and organizational skills
  • Detail-oriented
  • Possess strong organizational skills
  • Familiarity with the Code of Federal Regulations as they pertain to human subject protection
  • Ability to develop and maintain strong professional relationships with all providers and research subjects
  • Strong computer skills
  • Maintains confidentiality of patient and study information
  • Excellent working knowledge of ICH-GCP Guidelines and all Federal regulations

Responsibilities:
- Coordinate and oversee clinical research studies from start to finish
- Develop and maintain study protocols and documentation
- Recruit, screen, and enroll eligible participants for clinical trials
- Collect and manage data, ensuring accuracy and completeness
- Conduct participant assessments and interviews
- Monitor participant safety and report adverse events
- Collaborate with healthcare professionals and research staff
- Ensure compliance with study protocols, regulatory requirements, and ethical guidelines
- Maintain study records and documentation in accordance with Good Clinical Practice (GCP) standards
- Assist with the preparation of research reports and publications

Qualifications:

-Medical Assistant (CCMA, CMA, RMA)
- Knowledge of medical terminology and clinical research processes
- Experience in supervising or coordinating research activities is preferred
- Proficiency in data collection, management, and analysis
- Familiarity with clinical development processes and regulatory requirements
- Ability to use statistical software for data analysis is a plus
- Strong organizational skills with attention to detail
- Excellent communication and interpersonal skills
- Knowledge of compliance management, including HIPAA regulations
- Familiarity with blood sampling procedures for laboratory analysis

This is an exciting opportunity for a motivated individual to contribute to the advancement of medical research. We offer competitive compensation and benefits packages. If you are passionate about clinical research and meet the qualifications outlined above, we encourage you to apply.

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