Clinical Research Associate
The Clinical Research Associates (CRA) is responsible for assigned aspects of clinical monitoring and site management in accordance with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonization - Good Clinical Practice (ICH-GCP). Site visits are conducted to assess protocol and regulatory compliance, data reliability, and the proper care and treatment of study subjects. Please note: This is not a remote position.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provides case support to research sites across multiple studies.
- Prepare for, plan, organize and conduct site qualification, site initiation, interim and close-out visits.
- Completes monitoring reports within two weeks of visit date.
- Train site staff on therapeutic areas, protocol requirements, study device, proper source documentation and case report form completion.
- Order, track, and manage investigational product (IP) and trial materials as needed.
- Oversee and document IP dispensing, inventory and reconciliation.
- Protect subjects’ confidentiality and verify IP was dispensed and administered according to protocol.
- Ensure compliance with the patient-informed consent process.
- Ensure compliance in reporting adverse events/serious adverse events according to the study protocol and applicable regulatory agencies.
- Ensure compliance with Standard Operating Procedures (SOPs) and local regulations, and ICH, and GCP guidelines.
- Responsible for the creation and maintenance of the trial master file, regulatory binder, source documents, and photography slides.
- Regularly update project tracking tools and systems.
- Support electronic data capture (EDC) user acceptance testing and training as needed.
- Ensure timely resolution of all data queries remotely or at investigator site.
- Perform source data verification against CRF/EDC entries in compliance with the Monitoring Plan.
- Responsible for reviewing data and documents related to study endpoints.
- Assist with study report completion.
- Create adjudication packets under the supervision of study management.
QUALIFICATIONS / EDUCATION:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Minimum BS/BA degree.
- Minimum 1+ years’ experience directly supporting clinical research or relevant experience in medical/scientific area.
- Demonstrates working knowledge of GCP, ICH guidelines, ISO Standards, and FDA regulations.
- Proficient in Acrobat Adobe, Microsoft Word, Excel, Power Point, and the ability to quickly become proficient in a variety of other computer software programs.
- Experience in using EDC and CTMS systems is desirable.
- Experience in monitoring clinical trials is desirable.
- Excellent oral and written communication skills.
- Excellent record-keeping skills; good documentation practice.
- Ability to work well in a team environment.
- Customer focus.
- Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
- A pro-active, committed and motivated attitude.
- Flexibility in work hours and readiness to travel. Travel may be up to 75%.