Clinical Research Associate II
4 weeks ago
Minimum Qualifications:
- Bachelor's degree in a life science-based field
- Previous work experience as a study coordinator on a clinical trial
- Bilingual in Spanish
- Three years of job-related experience
- GCP, HIPAA, Conflict of Interest training (CITI coursework available, if needed)
- Excellent written, verbal, and interpersonal communication skills
- Attention to detail
- Proficiency in MS Office Suite
- 3+ years of professional experience in a clinical research environment
- Authorization to work in the US with no future restrictions
- Occasional project-specific work may take place on weekends
- Ability to assess study participants for adverse reactions or complications and manage side effects of study-related drugs
- Establish and maintain strong partnerships with subjects to achieve study objectives
- Direct acquisition and analysis of laboratory research data following GCP and FDA regulations
- Prepare and maintain IRB and regulatory documentation for various projects and consent patients for clinical research
- Facilitate constant communication between principal investigators, Co-Is, facilitators, CTRC staff, and patients to address concerns and maximize eligibility and enrollment
- Maintain audits, collect/organize/communicate observations, and create written outlines for weekly executive meetings
- Assist in preparation of investigator-initiated protocols, IRB submissions, and research budgeting contracts
- Perform routine monitoring activities ensuring quality control at study visits along with proper documentation and GCP
Responsibilities:
- Interpret, adhere to, and enforce detailed research protocols and regulatory requirements from screening to study close-out. Maintain the Investigator Binder and Subject Binder in a complete and orderly manner, available for audits at any time.
- Schedule subjects for study procedures; initiate/coordinate drug orders, laboratory procedures, and treatments for patients based on standing protocol orders. Coordinate appointments for subjects with their assigned specific facilitator. Complete CRFs and forms for subject-related costs reimbursement.
- Adhere to documentation procedures to ensure cGMP and GCP. Implement GCP and HIPAA compliance for all study-related activities.
- Communicate effectively with team members, research manager, and physicians via oral, written, and teleconferencing for study-related and ancillary activities. Present research findings to the supervisor through verbal and written communications.
- Maintain confidentiality of patient-related records (HIPAA), including written and verbal communications.
Salary: $32-$38
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