Clinical Research Associate

Independently conduct pre-study, initiation, routine monitoring and closeout visits and ensures these visits are completed according to the Clinical Monitoring Plan(s), SOPs, and ICH/GCP. Trains the study investigators and staff during the SIV and periodically when there are trial-specific or industry standard updates and when it is required due to noncompliance of ICH/GCP and/or protocol. Prepares site visit reports and sends confirmation/follow-up letters to sites per the Clinical Monitoring Plan(s) and maintains appropriate documentation regarding site management. Conducts and documents periodic email and telephone contact with sites in accordance with the Clinical Monitoring Plan. Verifies data entered into the case report forms (CRFs) is consistent with subject clinical records, electronic medical records and source data to ensure accuracy. Ensures data collection timelines and deliverables are met at assigned clinical sites in accordance with study plans. Works with Data Management to ensure the query resolution process is followed and completed. Identifies, analyzes, and reports protocol deviations in accordance with the Protocol Deviation Plans and monitors site submission to the IRB/EC per reporting policies. Ensures site compliance with the SAE reporting to client per protocol and other regulations. Ensure adequate review of site patient records to ensure SAE reporting to Pharmacovigilance is accurate and complete. Ensures site adherence to study protocols and compliance with ICH/GCP/local regulations at assigned clinical sites. Immediately reports non-compliance to the CTM and/or head of clinical operations. Assists the Clinical Team Lead and/or department leads of Clinical Operations in the development and implementation of corrected actions for addressing non-compliance issues at individual sites and across study, including timely follow-up to routine and for cause Quality Assurance audits. With minimal guidance, provide potential solutions and corrective actions to the Clinical Team Lead for site performance issues. Work with investigators on their patient recruitment and screening strategies. Manages, tracks and reports progress of assigned sites, including site initiation activities, patient screening/enrollment, data collection, SAE/adverse event documentation, and IP/lab supply inventory. Partners with the in-house Clinical Operations Assistants and/or Clinical Operations Associates in the collection, review, and tracking of essential documents to ensure completeness of both site files and eTMF. Upload documents into eTMF and completes coding and QCs, as required. Assists with preparing, distributing and presenting materials for study-related training Provides ongoing study-related training (i.e., EDC and SAE) and support to site staff as necessary. May collaborate with the department leads and/or in-house clinical staff roles on the development of certain study-specific plans and/or processes. Ensure proper collection, storage and shipment of laboratory specimens. Participates in Clinical Project Team Meetings and provides site activity updates. Other duties as assigned by the Head of Clinical Operations and other department leads Job Title: Clinical Research Associate Independently conduct pre-study, initiation, routine monitoring and closeout visits and ensures these visits are completed according to the Clinical Monitoring Plan(s), SOPs, and ICH/GCP. Trains the study investigators and staff during the SIV and periodically when there are trial-specific or industry standard updates and when it is required due to noncompliance of ICH/GCP and/or protocol. Prepares site visit reports and sends confirmation/follow-up letters to sites per the Clinical Monitoring Plan(s) and maintains appropriate documentation regarding site management. Conducts and documents periodic email and telephone contact with sites in accordance with the Clinical Monitoring Plan. Verifies data entered into the case report forms (CRFs) is consistent with subject clinical records, electronic medical records and source data to ensure accuracy. Ensures data collection timelines and deliverables are met at assigned clinical sites in accordance with study plans. Works with Data Management to ensure the query resolution process is followed and completed. Identifies, analyzes, and reports protocol deviations in accordance with the Protocol Deviation Plans and monitors site submission to the IRB/EC per reporting policies. Ensures site compliance with the SAE reporting to client per protocol and other regulations. Ensure adequate review of site patient records to ensure SAE reporting to Pharmacovigilance is accurate and complete. Ensures site adherence to study protocols and compliance with ICH/GCP/local regulations at assigned clinical sites. Immediately reports non-compliance to the CTM and/or head of clinical operations. Assists the Clinical Team Lead and/or department leads of Clinical Operations in the development and implementation of corrected actions for addressing non-compliance issues at individual sites and across study, including timely follow-up to routine and for cause Quality Assurance audits. With minimal guidance, provide potential solutions and corrective actions to the Clinical Team Lead for site performance issues. Work with investigators on their patient recruitment and screening strategies. Manages, tracks and reports progress of assigned sites, including site initiation activities, patient screening/enrollment, data collection, SAE/adverse event documentation, and IP/lab supply inventory. Partners with the in-house Clinical Operations Assistants and/or Clinical Operations Associates in the collection, review, and tracking of essential documents to ensure completeness of both site files and eTMF. Upload documents into eTMF and completes coding and QCs, as required. Assists with preparing, distributing and presenting materials for study-related training Provides ongoing study-related training (i.e., EDC and SAE) and support to site staff as necessary. May collaborate with the department leads and/or in-house clinical staff roles on the development of certain study-specific plans and/or processes. Ensure proper collection, storage and shipment of laboratory specimens. Participates in Clinical Project Team Meetings and provides site activity updates. Other duties as assigned by the Head of Clinical Operations and other department leads Qualifications Bachelor’s Degree (BA/BS) in life sciences or nursing degree Minimum of four (4) or more years of relevant experience in clinical research or healthcare related industry including a minimum of 3 years direct field monitoring experience, or equivalent combination of education and experience Experience in oncology is highly preferred Experience/training in the following areas: GCP/ICH Guidelines, Good Quality Practices, 21CFR/FDA Regulations, HIPAA, Drug Development and Approval Process Proficiency with MS Office Excellent oral and written communication skills including presentation skills Ability and willingness to travel to investigational sites for on-site monitoring visits, up to 30% of the time. Ability to conduct remote monitoring visits and complete site management tasks Work Environment This is a fully on-site position in San Diego, California, requiring presence 5 days a week. While there is no flexibility for hybrid work, the hours can be adjusted between 7-4, 8-5, or 9-6 to suit individual needs. Job Type & Location This is a Contract position based out of San Diego, CA. Pay And Benefits The pay range for this position is $38.00 - $65.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in San Diego,CA. Application Deadline This position is anticipated to close on Sep 25, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. San Francisco Fair Chance Ordinance Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI) We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr Actalent