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Ich Gcp Jobs in Riverside, CA (NOW HIRING)

Working knowledge of HIPAA, ICH, GCP, and regulatory requirements related to clinical research. * Experience with cardiovascular or structural heart therapeutic areas is a significant advantage.

Participates in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard ...

Participates in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard ...

Participates in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard ...

Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard ...

... ICH-GCP). Preferred: Ability to conduct informed consent. Working knowledge of Cerner or equivalent electronic medical record system. Knowledge of sample identification, processing and storage.

Senior Manager, Clinical Compliance

Irvine, CA ยท On-site +1

$160K - $170K/yr

Monitor and communicate regulatory developments and GCP guidance updates (FDA, ICH, EU CTR); evaluate impact on operations and procedures and serve as the department's internal GCP compliance subject ...

Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard ...

Showing results 21-40

Ich Gcp information

See Riverside, CA salary details

$51.6K

$121.3K

$183.6K

How much do ich gcp jobs pay per year?

As of Aug 6, 2026, the average yearly pay for ich gcp in Riverside, CA is $121,339.00, according to ZipRecruiter salary data. Most workers in this role earn between $88,700.00 and $149,700.00 per year, depending on experience, location, and employer.

How to become ICH GCP certified?

To become ICH GCP certified, individuals typically complete a recognized GCP training course that covers clinical trial regulations, ethical standards, and Good Clinical Practice guidelines. After training, some certifications require passing an exam to demonstrate understanding of GCP principles, which are essential for roles in clinical research and trial management.

What are the key skills and qualifications needed to thrive as an ICH GCP professional?

To thrive as an ICH GCP professional, you need a solid understanding of clinical research principles, regulatory compliance, and the ethical conduct of clinical trials, typically supported by relevant life sciences degrees and GCP certification. Familiarity with electronic data capture (EDC) systems, clinical trial management systems (CTMS), and regulatory documentation platforms is essential. Attention to detail, strong communication, and organizational skills help ensure protocol adherence and effective teamwork. These competencies are critical for safeguarding participant safety, ensuring data integrity, and meeting regulatory standards in clinical research.

What are some common challenges faced by professionals working in ICH GCP roles, and how can they be addressed?

Professionals in ICH GCP roles often encounter challenges such as ensuring strict regulatory compliance, managing complex documentation, and maintaining clear communication across multi-disciplinary clinical trial teams. Staying updated with evolving global regulations and standards can also be demanding. To address these challenges, it's important to participate in ongoing training, leverage robust project management tools, and foster open lines of communication among stakeholders. Building strong relationships with site staff and regulatory authorities further supports smooth trial operations.

What is the difference between Ich Gcp vs Cloud Engineer?

AspectIch GcpCloud Engineer
CertificationsGoogle Cloud certifications (e.g., Associate Cloud Engineer, Professional Cloud Architect)Various cloud certifications (AWS, Azure, Google Cloud)
Work EnvironmentPrimarily in Google Cloud environments, focusing on GCP tools and servicesIn diverse cloud platforms, including AWS, Azure, and GCP, depending on employer
Industry UsageUsed in companies leveraging Google Cloud Platform for their infrastructureCommon across multiple industries adopting cloud solutions
Job FocusImplementing, managing, and optimizing GCP servicesDesigning, deploying, and maintaining cloud infrastructure across platforms

While both roles involve cloud technology, Ich Gcp specializes in Google Cloud Platform services, whereas a Cloud Engineer may work across multiple cloud providers. The choice depends on the company's cloud strategy and required certifications.

What are ICH GCP guidelines?

ICH GCP, or International Council for Harmonisation Good Clinical Practice, are ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human subjects. These guidelines ensure that the rights, safety, and well-being of trial participants are protected and that clinical trial data are credible and accurate. ICH GCP is widely accepted internationally and is required by regulatory authorities in many countries for clinical research. Adhering to these guidelines is crucial for anyone involved in clinical trials.
What cities near Riverside, CA are hiring for Ich Gcp jobs? Cities near Riverside, CA with the most Ich Gcp job openings:
Infographic showing various Ich Gcp job openings in Riverside, CA as of August 2026, with employment types broken down into 87% Full Time, and 13% Contract. Highlights an 87% In-person, and 13% Hybrid job distribution, with an average salary of $121,339 per year, or $58.3 per hour.

Specialist, Clinical Safety

JenaValve

Irvine, CA โ€ข On-site

$100K/yr

Full-time

Re-posted 8 days ago


Job description

Job Title: Specialist, Clinical Safety
Role Level: Individual Contributor (IC)
Supervisor/Manager Title: Senior Manager, Clinical Safety
Job Location & Environment: Irvine, CA - Corporate Office
Job Description Summary: Reporting to the Senior Manager, Clinical Safety, the Specialist, Clinical Safety supports the conduct and timely execution of JenaValve clinical trials by monitoring subject safety, ensuring accurate and compliant adverse event data reporting in clinical databases, and contributing to the review and analysis of clinical safety data. The role collaborates closely with cross-functional teams including Project Management, Field Monitoring, Regulatory Affairs, and the Case Review Board to maintain the quality and integrity of safety data collected across all active trials, including the ALIGN-AR Pivotal Trial, JENA-VAD Registry, ALIGN-AR EFS Trial, and the ARTIST Trial.
Job Responsibilities:
  • Conduct assessments of adverse events (AEs) and complaints across multiple clinical studies, including UADE (Unanticipated Adverse Device Effect) determinations; perform complaint handling assessments and report AEs per regulatory requirements, trial safety processes, and JenaValve procedures.
  • Review and analyze aggregate safety reports to identify early safety signals; escalate findings to leadership with recommended next steps.
  • Track timeliness of AE and SAE reporting by investigational sites and follow up as needed to ensure compliance with protocol-specified timelines.
  • Interact with investigational sites and field monitors to obtain additional pertinent information on Case Report Forms and medical documentation (source documents).
  • Manage, prepare, and review event narratives for internal review or external reviews (e.g., Clinical Events Committee, Data Safety Monitoring Board) and for regulatory submissions.
  • Provide support to the MedDRA coding team on complex coding questions; participate in MedDRA coding team meetings and advise on important medical concepts.
  • Provide clinical and medical subject matter expertise to address safety-related questions from internal study teams, field support personnel, monitors, and study sites during the conduct of studies.
  • Contribute to clinical aspects of protocol development; specifically develop the Safety section of clinical trial protocols including adverse event definitions, AE reporting requirements, and risk sections.
  • Collaborate with data management and cross-functional teams on the development of case report forms, study-specific safety reports, and other study forms, ensuring alignment with clinical definitions and EDC data flows.
  • Support DSMB and CEC startup and management activities including vendor selection and approval, member selection, charter development, and ongoing conduct during clinical trials.
  • Lead site CRF development for AE Main Forms and AE Sub-forms; review edit checks and provide input into other CRF form development as needed.
  • Support PMA/APR activities including query closure, case narratives, and accurate presentation of endpoint-related data.
  • Assist the Clinical Safety team in daily safety reviews, data reconciliation, periodic reporting, and identification of necessary source documents.
  • Contribute to other clinical and medical affairs activities as needed and support continuous process improvement.
  • Complete training for internal SOPs and maintain current knowledge required for the role.

Required Education and Experience:
  • 2+ years of experience in clinical trial research required; medical device experience strongly preferred.
  • Bachelor's degree or higher in a life sciences, health sciences, or related field required; advanced clinical degree (NP, PA, MD, or international equivalent) highly preferred.
  • Working knowledge of HIPAA, ICH, GCP, and regulatory requirements related to clinical research.
  • Experience with cardiovascular or structural heart therapeutic areas is a significant advantage.
  • Strong organizational skills and time management abilities in a dynamic, fast-paced environment; ability to manage multiple concurrent priorities.
  • Excellent critical thinking skills and strong written and verbal communication skills.
  • Self-motivated, detail-oriented, and able to work independently as well as part of a collaborative team.

Skills and Abilities Required for This Job:
  • Clinical knowledge in cardiology; structural heart disease or transcatheter valve therapy experience preferred.
  • Knowledge of GCPs governing clinical trial conduct; working knowledge of medical device regulations and ICH guidelines.
  • Experience working across all phases of clinical study conduct from a clinical safety perspective.
  • Familiarity with MedDRA coding, adverse event terminology, and safety database management.
  • Experience with EDC (Electronic Data Capture) platforms for clinical trial management and safety reporting.
  • Basic understanding of clinical trial design and statistical concepts as applied to safety evaluation.
  • Ability to work collaboratively as part of a multi-functional medical device development team.
  • Excellent oral and written communication skills; strong interpersonal skills and ability to work effectively cross-functionally and cross-culturally.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

Physical Requirements:
  • Standard office environment requirements.
  • Minimal travel, up to 10%.