Senior Research Coordinator

Location
Texas, United States
Salary
Salary Not Specified
Posted
Apr 01, 2021
Employment Type
Full Time


Summary

The Senior Research Coordinator will work independently to manage all significant aspects of the large and small clinical research trials under the supervision of the primary investigator. Will train and provide guidance to less experienced staff. Provide guidance to the group in determining our participation of solicitation for new study trials. Determines effective strategies for promoting/recruiting research participants in long term clinical trials. Exhibits excellent communication skills, both orally and written.

Job Duties
  • Protocol/Project Management:
  • Assist investigators in the overall conduct of clinical trials
  • Maintain current regulatory files with study sponsors
  • Monitor IRB submissions and respond to requests and questions with central and local IRBs
  • Interact with study sponsors and monitors and report SAEs and resolves study queries
  • Provide leadership for all studies/trials assigned, develop and implements policies and procedures, and identify and implement corrective actions/process when required.
  • Study Management:
  • Interface with research subjects with the purpose of recruitment, screening, and enrollment; which may include scheduling research visits, procedures and lab testing.
  • Resolve all issues related to research study protocols.
  • Evaluate subjects for study eligibility and continued participation in the study.
  • Consent subjects to research protocols following Good Clinical Practice guidelines
  • With appropriate training will perform venipuncture, ECG, spirometry, sweat testing, specimen collections and processing
  • Will collect, process, ship and maintain paperwork for blood and/or other biological specimens according to study protocol
  • Assist with audits of study trials records and specimens collections
  • Appropriate handling and distribution of investigational products to subjects
  • Data Management:
  • Oversee the data management of studies ensuring accurate study subject documentation
  • Enter subject data into all required electronic data collection systems
  • Retrieve, maintain and submit test results to appropriate study sponsors or PIs
  • Report serious adverse events to include follow-up when necessary
  • Assist investigators in the overall conduct of clinical trials
  • Maintain current regulatory files with study sponsors
  • Monitor IRB submissions and respond to requests and questions with central and local IRBs
  • Interact with study sponsors and monitor and report SAEs and resolves study queries
  • Provide leadership for all studies/trials assigned, develop and implement policies and procedures, and identify and implement corrective actions/process when required


Minimum Qualifications
  • Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
  • Five years of relevant experience.


Preferred Qualifications
  • Familiarity with EPIC/EMR
  • Working knowledge of central and local IRBs such as WIRB, Advarra etc
  • Pediatric experience
  • CCRC, CCRP, SOCRA
  • At least two years of relevant experience in a research or health care setting


Work is located in busy patient clinics, hospitals, office areas, and/or laboratories where there are potential exposures to blood borne pathogens (blood &/or other potentially infectious materials), drugs, chemicals, radiation, and physical hazards. Patient interaction and interaction with other employees is required.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

6450

CA; CH

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