Clinical Research Assistant
About The Position
The Research Assistant supports clinical research operations by assisting Study Coordinators and the study team in executing clinical trial activities. This role ensures compliance with study protocols, Good Clinical Practice (GCP), and Standard Operating Procedures (SOPs) while maintaining confidentiality and high-quality standards. The Research Assistant provides administrative and operational support for clinical trials, including document preparation, data entry, subject recruitment, and protocol-specific activities such as vital signs and specimen collection. The position reports to the Site Manager or Site Director and works under the direction of Clinical Research Coordinators.
Requirements
- Required: High school diploma or GED.
- Excellent communication (verbal and written) and interpersonal skills.
- Strong organizational and time management abilities.
- Detail-oriented with high accuracy.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint, SharePoint).
- Knowledge of medical terminology and clinical research concepts.
- Ability to work independently and collaboratively in a team.
- Problem-solving and analytical skills.
- Ability to manage small projects and respond to urgent needs effectively.
Nice To Haves
- Preferred: Bachelor’s degree.
- Experience in clinical research setting or related environment preferred.
- Certification as a Medical Assistant is preferred.
- At least one year of experience in medical history, medication history, and vital signs preferred.
- Familiarity with clinical trial management systems is a plus.
- Bilingual: Proficiency in Spanish and English, including the ability to speak, read, and write in both languages is preferred.
- Familiarity with electronic case report form systems (e.g., Medidata Rave, Inform, TrialKit) preferred.
Responsibilities
- Ensure the confidentiality of clinical research volunteers and sponsors
- Maintain and advocate a high level of customer service and quality within the department
- Assist in the maintenance of Clinical Conductor
- Maintain the ERP system including preparing, filing, assisting with updates and archiving study related information
- Perform data entry and query resolution
- Prepare, handle, distribute, track and maintain clinical trial related supplies
- Assist with the pre-screening, screening, recruiting and enrollment of research subjects as authorized
- Assist with educating study volunteers on study procedures such as diary completion, electronic devices and expected outcomes in a profession and accountable manner following protocol requirements.
- Assist in tracking volunteer visits in Clinical Conductor, rescheduling as needed and update study coordinators in a timely fashion regarding missed visits or compliance issues.
- Perform protocol specific activities including but not limited to medical history, vital signs, electrocardiograms and specimen collection.
- Record adverse events and concomitant medication use and follow-up on open adverse events until through resolution.
- Obtain and document study related events and data in compliance with GCP/SOPs
- Communicate necessary volunteer information in a timely manner to study coordinator/PI on an ongoing basis.
- Assure source documents/charts are prepared for future study visits.
- Proactively escalate issues and/or problems
- Develop strong working relationships and maintain effective communication with study team members, Investigators and practice staff
- May collect, process and ship laboratory specimens at certain sites and or as needed
- Other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
11-50 employees
