The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. Position is responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB.  Provides limited patient contact as needed for study and assist with study budget and patient research billing.  This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

Job Duties and Responsibilities:

Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.

Evaluates and abstracts clinical research data from source documents.

Ensures compliance with protocol and overall clinical research objectives.

Completes Case Report Forms (CRFs).

Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.

Provides supervised patient contact or patient contact for long term follow-up patients only.

Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.

Assists with clinical trial budgets and patient research billing as needed

Schedules patients for research visits and research procedures.

Responsible for sample preparation and shipping and maintenance of study supplies and kits.

Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.

Maintains research practices using Good Clinical Practice (GCP) guidelines.

Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

Participates in required training and education programs.

Education:

High School diploma/GED required.

BA/BS degree in Science, Sociology or related degree preferred. 

Experience: 

Understanding of general research objectives. 

1 year of clinical research related experience preferred.

Department specific job duties

Provides primary support to the Research Director on his academic activities (seminars, lectures, meeting, writing, and editorial commitments). May include preparing first drafts, editing drafts, and submitting materials on his behalf. 

Provides other general administrative support to the Research Director, as needed. 

Provides support to the biostatistician, investigators, and /or data managers on various tasks involving data extraction, data management, and data analysis. May carry out independent task with guidance from investigators. 

Provide management assistance support to the Cardiac Imaging Research Team, as needed. 

Under the guidance of the Team Lead and principal investigator, provides support for projects conducted in the Cardiac Imaging Research section, including all phases of the study – start-up (planning and training), study conduct (screening, recruitment, visits, data queries), and close-out (final queries, archiving documentation). Retrieves non-controlled substance medication from and return unused medication to pharmacy when medication is needed for administration to a patient by a clinic staff member.