Clinical Research Specialist

St. Joseph Hospital & Medical CenterPhoenix, AZ
Onsite

About The Position

The Lonnie and Muhammad Ali Movement Disorder Center is searching for an experienced clinical research coordinator to fill our Clinical Research Specialist position. The position is responsible for the conduct of clinical research studies under the oversight of the principal investigator. Responsibilities will include recruiting, maintaining study logs, conducting informed consent discussions, scheduling and completing study visits per protocol and completing required visit documentation. The Clinical Research Specialist will be the primary liaison with study sponsors through the conduct of the study. Previous experience with Parkinson’s disease studies is preferred. The ability to multi-task and remain organized in a high volume clinical trial setting is required. Demonstrated knowledge and understanding of human research policies, regulations, procedures and standards as according to HIPAA, IRB, FDA, ICH, and GCP guidelines is required. Coordinates and schedules subject study visits to ensure adequate supplies, procedures and investigator availability Provides study specific, individualized education to study subjects and families. Ensures all appropriate subject consents are obtained. Collects and processes protocol required specimens. Acts as a liaison between Sponsor, Investigator, and Study Subject Collects all required study data and completes CRFs in a timely, accurate manner. Ensures study documents are maintained in compliance with applicable regulations, guidelines, and policies (i.e. FDA, OHRP, IRB). Collaborates with Investigator to identify adverse events/ serious adverse events to ensure study subject safety and accurate and timely reporting. Ensures appropriate internal and external customer service by demonstrating professional interactions with Sponsor, study monitors, and other departments. Complies with all regulatory and policy requirements. Demonstrates knowledge of federal and state regulations, guidelines, and policies governing the conduct of clinical trials. The Parkinson’s and Movement Disorders Division is seeking a Clinical Research Specialist to join our team. As as a Parkinson’s Foundation Center of Excellence, and Huntington’s disease Center of Excellence, we strive to offer the best care to our patients. We are also a world leader in Deep Brain Stimulation (DBS) surgery for the treatment of movement disorders. Our research division continues to expand offering cutting edge research and excellent patient care!

Requirements

  • Minimum 2 years related experience required.
  • Competent in computer skills including the Microsoft Office products required.
  • Associates degree in related field or an equivalent combination of relevant education and/ or job-related experience in lieu of degree required.
  • Demonstrated knowledge and understanding of human research policies, regulations, procedures and standards as according to HIPAA, IRB, FDA, ICH, and GCP guidelines is required.
  • The ability to multi-task and remain organized in a high volume clinical trial setting is required.

Nice To Haves

  • Previous experience with Parkinson’s disease studies is preferred.
  • Three (3) years clinical research experience preferred.
  • Bachelor's Degree in related field preferred.

Responsibilities

  • Recruiting, maintaining study logs, conducting informed consent discussions, scheduling and completing study visits per protocol and completing required visit documentation.
  • Primary liaison with study sponsors through the conduct of the study.
  • Coordinates and schedules subject study visits to ensure adequate supplies, procedures and investigator availability.
  • Provides study specific, individualized education to study subjects and families.
  • Ensures all appropriate subject consents are obtained.
  • Collects and processes protocol required specimens.
  • Acts as a liaison between Sponsor, Investigator, and Study Subject.
  • Collects all required study data and completes CRFs in a timely, accurate manner.
  • Ensures study documents are maintained in compliance with applicable regulations, guidelines, and policies (i.e. FDA, OHRP, IRB).
  • Collaborates with Investigator to identify adverse events/ serious adverse events to ensure study subject safety and accurate and timely reporting.
  • Ensures appropriate internal and external customer service by demonstrating professional interactions with Sponsor, study monitors, and other departments.
  • Complies with all regulatory and policy requirements.
  • Demonstrates knowledge of federal and state regulations, guidelines, and policies governing the conduct of clinical trials.

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Education Level

Associate degree

Number of Employees

501-1,000 employees

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