LA Biomed Torrance , CA 90501
Posted 3 weeks ago
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
LA Biomed