Description:

Translational Research in Oncology, Inc., Senior Clinical Research Associate (Multiple Positions), Los Angeles, CA.

Input, analyze, and maintain clinical study data using clinical trial management software and tracking systems. Ensure clinical data integrity, validity, and reliability in accordance with standard operating procedures (SOPs) and regulatory requirements. Perform query resolution in a timely manner to ensure clean data availability for study analyses. Verify source documents and validate Case Report Forms (CRFs). Review site-related document content and data for consistency and compliance with ICH-GCP guidelines, SOPs, FDA requirements, and local regulatory requirements. Reconcile investigator study files. Report Serious Adverse Events (SAEs) according to project specifications. Assist with the implementation of corrective and preventive actions, when appropriate. Participate in budget negotiations. Mentor and train junior staff. Adhere to corporate internal polices and requirements related to the timely submission of training documentation, visit plans, timesheets, and expense reports. Monitor activities at assigned clinical oncology study sites to ensure adherence to ICH GCP guidelines, SOPs, regulatory requirements, standard guidelines, instruction manuals, and study protocols. Track study progress and provide regular status updates. Conduct pre-study, initiation, routine monitoring, and termination visits at assigned clinical study sites. Assist with on-site audits and preparation of site audit report replies. Contribute to the completion, compilation, and submission of regulatory documentation.

SALARY: $132,413 - $165,000 per year

WORK SCHEDULE: 40 hours per week, M-F (9:00 a.m.–5:00 p.m.)

JOB REQUIREMENTS:

Must have a Bachelor’s degree or foreign equivalent in Health Sciences, Medicine, Medical Science, Nursing, Pharmacy or a related field, and 5 years of post-bachelor’s, progressive related work experience with a clinical research organization or pharmaceutical company; OR a Master’s degree or foreign equivalent in Health Sciences, Medicine, Medical Science, Nursing, Pharmacy or a related field, and 3 years of related work experience with a clinical research organization or pharmaceutical company.

Of the required experience, must have 3 years of experience with the following: Evaluating and utilizing information systems in the context of clinical research trials; Utilizing clinical trial management software, including Oracle Clinical/OR-RDC, Medidata, or Inform; Adhering to ICH-GCP guidelines in the context of clinical research trials; Ensuring compliance with FDA and local regulatory requirements that apply to clinical research trials; Working with clinical research documentation and data that references terminology specific to the field of medical oncology; Verifying source documents; and Resolving data queries.Of the required experience, must have at least 1 year of experience monitoring oncology clinical trials.

Domestic travel to various, unanticipated work locations required up to 60% of the time. Telecommuting permitted from anywhere within the United States when not working from an assigned location or traveling for business purposes.

QUALIFIED APPLICANTS: Interested applicants should email their CV to human.resources@trioncology.org & specify “Senior Clinical Research Associate” in the subject line.