Pulmonary Research Study Coordinator — Data & IRB

Job Summary:

Coordinates collection, analysis, processing & reporting of data & assists Principal Investigator (PI) in judging the validity of test data obtained in regard to biomedical &/or social-behavioral research study(ies) of limited complexity involving co-investigators, multiple campuses &/or universities. Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).

Specific Responsibilities:

Technical

• Participates in the planning & conduct of research study including participant recruitment and retention.
• Obtains informed consent
• Collects, compiles, tabulates & processes responses.
• Gathers information.
• Extracts & analyzes data from medical charts.
• Completes basic clinical procedures such as drawing blood & obtaining blood pressure.

Administration

• Collates relevant mathematical results & prepares tables, charts & graphs reflecting relationships of multiple tests.
• Prepares reports for investigators and sponsors on recruitment status and other pertinent study data.
• Writes portions of grant applications & co-author scientific papers.
• Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols.

Finance

• May process payments for research participants per study protocol.
• Works with industry representatives to negotiate tentative grant funding.
• Coordinates reimbursements for expert panel travel, consultant pay, additional gift card orders, etc. & ensure costs remain within allotted grant budget.

Supervision

• May provide work direction &/or train other research staff to interview/test participants.
• May act as a mentor in regard to education of junior coordinators.

Performs other duties as assigned.

Minimum Qualifications: (Education, experience, and any other certifications or clearances)

• Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR
• Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience.
• Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.

Minimum Competencies (Skills, knowledge, and abilities)

• Ability to become American Heart Association or American Red Cross Healthcare certified in cardiopulmonary resuscitation (CPR).
• Ability to successfully complete NU's IRB CITI Human Subjects Protection (Biomedical) and Good Clinical Practice (GCP) training before interacting with any participants & must re-certify every three (3) years.

Ability to successfully complete the requirements of the Northwestern Memorial Hospital Research Access Program.

Preferred Qualifications (Education and experience)

• Phlebotomy certification and prior working experience as a phlebotomist.
• Prior working experience handling/processing human subject laboratory samples.
• Prior working experience involving reviewing hospital medical records &/or electronic health record systems.
• Prior working experience involving IRB regulatory responsibilities, e.g., research protocol submissions.

Certification as a clinical research coordinator, ACRP or SOCRA.

Preferred Competencies (Skills, knowledge, and abilities)

• Skill/ability to communicate in the Spanish language.
• Skill/ability in use of Microsoft Office (Excel, Outlook, & Word).
• Skill/ability in use of clinical research databases, e.g., REDCap.
• Knowledge of medical terminology.
• Action oriented
  - Willing or likely to take practical action to deal with a problem or situation.
• Coachability
  - Receptive to feedback, willing to learn, embracing continuous improvement.
• Collaboration
  -…