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Clinical Research Manager

3 months ago

Houston, United States Houston Journal of Health Law & Policy Full time
Description

Oversees investigator-initiated and sponsored clinical research projects. Manages graduate students, post-doctoral fellows and Clinical Lab staff in providing complex administrative duties to support the study and ensure compliance with regulations.
  1. Manage advertising and recruitment of clinical research subjects within the clinic and the community; conduct phone interviews, answer questions regarding ongoing studies, screen, and consent and enroll study subjects.
  2. Track study recruitment, enrollment, drop out, and screen failure rates.
  3. Schedule study visits and provide visit reminders.
  4. Participate in site qualification/initiation/close-out and other study-specific training.
  5. Perform limited study procedures with appropriate training; including questionnaires, automated machinery and vision testing.
  6. Assist with preparation of all IRB and Regulatory documents including but not limited to trial registrations and sponsor reports.
  7. Maintain accurate source documentation and appropriate forms including participant records, drug documentation, reconciling study drug accountability; monitors documentation for quality and accuracy.
  8. Ensure research studies are conducted in accordance with Good Clinical Practice (GCP) guidelines and requirements of the University of Houston and study sponsors.
  9. Maintain licensure and certification records for all study personnel. Resolve data queries with study sponsors. Maintain supply inventory (general office and lab) and coordinate maintenance and calibration of equipment. Establish effective, collaborative working relationships with clinicians, patients, and sponsors. Provide additional support and guidance for graduate students involved in research. Performs other job-related duties as required.


EEO/AA

Standard Attachments

Candidates interested in applying for the position must submit the following documents with the application:
  • Cover letter describing the manner in which your experience applies to the posting.
  • Resume
  • Salary History (list Employer name, dates, and last salary)
  • Three work references, including current and past supervisors. NOTE: We will maintain your confidentiality and notify you in advance of making contact with any of your references. References will be contacted only after the interviewing process has been completed.
Qualifications

Bachelors and 5 years experience

Requires a thorough understanding of both theoretical and practical aspects of an analytical, technical or professional discipline; or the basic knowledge of more than one professional discipline. Knowledge of the discipline is normally obtained through a formal, directly job-related 4 year degree from a college or university or an equivalent in-depth specialized training program that is directly Requires a minimum of five (5) year of directly job-related experience.

Additional Job Posting Information:
  • Department is willing to accept experience in lieu of education
  • Department is willing to accept education in lieu of experience
  • The candidate should have the ability to perform informed consent of research subjects, oversee regulatory/IRB compliance, manage procurement/financial documentation, develop SOPs, write basic protocols and other IRB documents (e.g. consents, recruitment materials, etc.) with minimal supervision