CLINICAL RESEARCH COORDINATOR II
UAB Medicine
Description
The University of Alabama at Birmingham (UAB), Psych - Behavioral Neurobiology, is seeking a Clinical Research Coordinator II.
This position will be involved in screening, recruitment, enrollment planning, consenting, running study visits (administer computer tasks, collect questionnaire data, blood samples, saliva samples), train junior team members, maintain subject-level and study-level documentation, collect and report AE data, submit annual reports, prepare and submit IRB documentation, monitor data flow, conduct QA, maintain study team compliance with training requirements, process and store samples, manage supplies, assist with SOP development, and attend trainings and meetings for two studies (observational neuroimaging study and randomized clinical trials) with patients with Functional Neurological Disorder and matched controls.
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
Schedules participants and conducts visits for all studies independently, including baseline and post-treatment visits and neuro-imaging visits. This includes proactively reaching out to treating Psychologists and scheduling follow-up visits to align with anticipated treatment completion.
Administers computer tasks during fMRI and outside of the scanner. Administers questionnaires and collects blood and saliva samples.
Trains others to conduct and document visits and protocol-specific testing/interviews.
Assists with development and follows procedures and documentation of study payment in a timely fashion.
Participates in recruitment of participants through screening efforts, including pre-screening medical records of potential participants on the waitlist for the FND treatment clinic, administering a structured interview (QuickSCID-5) for the purposes of matching FND patients and controls, and consenting participants according to regulatory guidelines.
Employs strategies to maintain recruitment and retention rates. Provide oversight and training to study team members who screen and consent participants.
Maintains subject-level documentation for all studies independently.
Provides oversight and training to study team members who maintain subject-level documentation, including documentation in the Electronic Medical Record.
Maintains training requirements and develops solutions to proactively ensure study team members' compliance with training requirements.
Independently maintains appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of records, etc.
Maintains study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, etc.).
Oversees maintenance of Delegation of Authority Logs and training of key personnel on study-specific duties.
Involved in the study feasibility process and may assist in budget development and billing procedures.
Prepares and submits multiple levels of research documentation (i.e. IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms).
Processes blood and saliva samples in preparation for storage in the freezer.
Manages site supplies (e.g., Vacutainers, butterfly needles, gauze, medical tape, Salivettes) and performs administrative duties in support of research conduction as needed.
Trains junior staff in the ethical conduct of research and provides guidance on strategies used to maintain safety.
Summarizes and clarifies for study teams the professional guidelines and code of ethics related to the conduct of clinical research.
Collects adverse event information independently and submits adverse event reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms).
Completes Case Report Forms (CRF) according to protocol.
Assists with the development of standard operating procedures (SOPs) for data quality assurance.
Organizes patient enrollment planning.
Conducts quality assurance activities.
Compiles and analyzes data.
Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected. This includes transferring neuroimaging data to a shared server and uploading data onto the supercomputer for analysis.
Maps protocol data flow.
Predicts areas of vulnerability for a protocol's data flow plan.
Determines areas where data provenance may be compromised.
Attends study, departmental, and institutional trainings and meetings as required, including weekly scheduled lab meetings, and performs other duties as assigned.
Performs other duties as assigned.
Annual Salary Range: $50,050 - $81,330
Qualifications
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.
A bachelor's degree in Psychology, Neuroscience, or a related field is preferred.
Experience working with medical populations and coordinating clinical research studies.
UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.