SUMMARY

The ideal candidate will be highly driven, self-motived, and eager to work both independently as well as be part of a dynamic team of research coordinators and physicians. The coordinator is responsible for all aspects of the research studies under the supervision of the primary investigator, including regulatory requirements, communicating with study sponsors, recruitment of subjects, accurate data collection and documentation, oversight of the safety of study subjects, data entry, and more. Additionally, this position is very hands on with the opportunity to utilize or develop numerous clinical skills including pulmonary function testing, ECG, venipuncture, sample collection, etc.

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

• Bachelor’s degree in a related field.
• Familiarity with EPIC/EMR
• Working knowledge of central and local IRBs such as WIRB, Advarra, etc.
• Completion of Good Clinical Practice (GCP) trainingWorking knowledge of clinical research terminology
• Effective communication and interpersonal skills
• Previously worked with a pediatric experience

Protocol/Project Management:

• Assisting investigators in the overall conduct of clinical trials
• Maintaining current regulatory files with study sponsors
• Monitors IRB submissions and responds to requests and questions with central and local IRBs
• Interacts with study sponsors and monitors and reports SAEs and resolves study queries
• Provides leadership for all studies/trials assigned, develops and implements policies and procedures, and identifies and implements 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
• Resolves all issues related to research study protocols
• Evaluation of subjects for study eligibility and continued participation in the study
• Consenting of 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 specimen collections
• Appropriate handling and distribution of investigational products to subjects

Data Management:

• Maintaining meticulously accurate study subject documentation
• Entering subject data into electronic data collection systems
• Prompt serious adverse event reporting and follow up

Other:

• Other duties as assigned