Clinical Research Associate II

Minimum Qualifications:

• Bachelor's degree life science-based degree

• Previous work experience as a study coordinator working on a clinical trial

• Bilingual in Spanish

• Three years job-related experience

• GCP, HIPAA, Conflict of Interest training (CITI coursework available, if needed).

• Excellent written, verbal, and interpersonal communication skills

• Attention to detail

• MS Office suite

• 3+ years of professional experience in a clinical research environment required

• Authorization to work in the US with no future restrictions.

• Although rare, project-specific work may take place on a weekend

• Assess study participants for adverse reactions or complications and manage side effects of study relate drugs.

• Establish and maintain a strong partnership with the subject 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 this projects and consent patients for clinical research.

• Facilitate constant communication between principal investigators, Co-Is, facilitators and CTRC staff, and patients to address concerns and maximize eligibility and enrollment.

• Maintain audits, collecting/organizing/communicating observations, and creating written outines for weekly executive meetings.

• Assist in preparation of investigator-initiated protocols, IRB submissions, and assist in 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-relate records (HIPAA) including written and verbal communications.

Salary: $32-$38