Benefits:- 401(k) matching
- Bonus based on performance
- Competitive salary
- Dental insurance
- Health insurance
- Opportunity for advancement
- Paid time off
- Tuition assistance
JOB SUMMARY
- The Clinical Research Assistant (RA) supports the research team in conducting clinical trials by recruiting study participants, collecting and managing data, ensuring protocol adherence, and assisting with administrative tasks, all under the supervision of a principal investigator (PI) while adhering to ethical and regulatory guidelines; their primary focus is to facilitate smooth operation of a clinical research study by performing tasks like subject screening, data entry, and study documentation.
ESSENTIAL JOB DUTIES:
- Collect and authenticate data collection forms otherwise known as case report forms
- Work closely with Clinical Research Coordinators (CRCs), Principal Investigators (PIs), and site staff to complete trials successfully.
- Screen potential study participants through medical record reviews.
- Maintain specific records of research activity to include regulatory forms, drug dispensation records, case reports and consent forms
- Ensure proper transmission of clinical case data to the data management centers, review case reports questions and problems and clarify or obtain alterations to data as appropriate.
- Process, label and ship study samples.
- Ensure lab supplies, sample kits and all study binders are properly maintained.
- Support CRCs to prepare for study visits and monitoring visits.
- Perform vital signs, EKG, phlebotomy and other study procedures as needed.
- Other duties as assigned.
OTHER SKILLS/ABILITIES:· A clear understanding of FDA regulatory requirements and clinical research protocols.
· Familiarity with commonly used concepts, practices, and procedures in the field.
· The ability to follow detailed instructions and predefined guidelines.
· Excellent communication and interpersonal skills
· Attention to details and being meticulous
· Responsible and punctual
· Ability to maintain confidentially
EDUCATION AND EXPERIENCE:· 2 years’ related experience with High School Diploma or 1 year experience with Associate's Degree
· 0–3 years of experience in clinical research or a related area.