Clinical Research Associate II

Minimum Qualifications:

Bachelor's degree in a life science-based field

Previous work experience as a study coordinator working 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

MS Office suite proficiency

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-related 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 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 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-related records (HIPAA) including written and verbal communications

Salary: $32-$38

#J-18808-Ljbffr