"CLINICAL RESEARCH COORDINATOR I"

CLINICAL RESEARCH COORDINATOR I

The University of Alabama at Birmingham (UAB), Med - Pulmonary/Allergy/Critical Care, is seeking a Clinical Research Coordinator I.

General Responsibilities

• To serve as coordinator for studies and provide support to other team members within the confines of the protocol as directed.
• To support screening and participant eligibility determination, working with more senior team members to ensure compliance.
• To conduct activities in accordance with the protocol, regulations and Good Clinical Practice (GCP).
• To assist with the study life cycle from start-up to closure, i.e., collecting and recording data, recruiting and performing follow-up with participants, scheduling visits and assisting in coordination of lab and fieldwork.

Key Duties & Responsibilities

1. Participates in the recruitment of participants through screening efforts, including the conduction of the consent process according to regulatory guidelines.
2. Coordinates care and/or follow-up functions of the study, including planning and developing related activities.
3. Arranges access to study medications, as needed, including authorization for prescriptions.
4. Employs strategies to maintain recruitment and retention rates. May manage investigational products (IP), including their administration to participants.
5. Employs the required system (including personnel) for handling, dispensing, and documenting IP for sponsored protocols.
6. Completes Case Report Forms (CRF) according to protocol.
7. Documents Adverse Events (AEs) and Serious Adverse Events (SAEs) as required by protocol and regulatory guidance.
8. Assists with the development of standard operating procedures (SOPs) for data quality assurance.
9. Maintains compliance with federal, state, and accrediting agencies (sponsors).
10. Maintains any required documentation. Has a working knowledge of institutional and departmental policies and processes, and maintains lab specimens.
11. Manages site supplies and performs administrative duties in support of research conduction as needed.
12. Attends study, departmental, and institutional trainings and meetings as required.
13. Performs other duties as assigned.

Annual Salary Range

$43,890 - $57,055

Qualifications

High School diploma or GED required.

Preferences

• Knowledge of GCP and ICH Guidelines and ability to follow established regulations, procedures, and protocols.
• Demonstrated ability to gather data and document procedures.
• Demonstrated ability to plan work and coordinate multiple projects.
• Demonstrated ability to communicate professionally verbally and in writing.
• The ideal candidates will have patient care experience and/or clinical research experience.