Clinical Research Assistant - Core-Ctr For Research Excel
Clinical Research
The Clinical Research Assistant supports multiple clinical research projects under the supervision of the Clinical Research Supervisors and Clinical Research Managers. Key duties include pre-screening potential participants against protocol eligibility criteria; obtaining and documenting informed consent for non-interventional registry/observational studies and select minimal-risk device studies; assisting with subject enrollment, randomization, and coordination of research visits; reviewing study lab manuals and collecting/processing specimens per protocol; performing accurate data entry from source documents to paper/electronic case report forms (including redaction as requested); and serving as a liaison between research staff and departments where research is conducted, along with other assigned tasks.
Qualifications
Qualifications
- Bachelor's Degree - Any field related to science or health care
- Working knowledge of clinical research concepts, regulations, and Good Clinical Practice (GCP) principles.
- Ability to interpret study protocols and apply inclusion/exclusion criteria during pre-screening.
- Understanding of informed consent requirements and ability to explain studies to participants in a clear, professional manner.
- Working knowledge of specimen collection, processing, labeling, storage, and shipment practices per protocol/lab manual.
- Proficiency with electronic data capture (EDC) systems, electronic medical records (EMR), and standard office software (e.g., Word, Excel, Outlook) as applicable to the role.
- Strong attention to detail and accuracy in source documentation review, data entry, and record maintenance
- Ability to prioritize tasks, manage multiple studies, and meet deadlines in a fast-paced environment.
- Effective written and verbal communication skills, including ability to coordinate with multidisciplinary teams and external study contacts.
- Professionalism and discretion when handling confidential and protected health information (PHI); ability to follow privacy and security practices.
- Problem-solving skills and ability to escalate issues appropriately to supervisors/PI/study team.
- Ability to work independently with direction, and collaboratively as part of a research team.
