Clinical Trial Operations & Documentation Specialist

Arrowhead Pharmaceuticals; San Diego (CA); Vor Ort; USD 60.000 - 80.000; Vollzeit

Zusammenfassung

Arrowhead Pharmaceuticals, Inc. in San Diego is seeking a detail-oriented Clinical Trial Associate to support Clinical Operations. The role focuses on administrative support, study tools, contract tracking, and regulatory document management to keep trials running smoothly.

You will coordinate with study teams, prepare study materials, and maintain the eTMF plan alignment with GDP/ICH-GCP standards. A 4-year degree and strong organizational skills are preferred in a fast-paced biopharma setting.

Qualifikationen

• Strong organizational skills and attention to detail.
• Proficient interpersonal, verbal and written communication skills.
• Ability to work effectively independently and in a collaborative team environment.
• Basic understanding of GDP and ICH-GCP.
• Proficiency with Veeva eTMF.
• Familiarity with MS Office tools including Outlook, Excel and DocuSign.

Aufgaben

• Develop and maintain study tools and trackers (e.g., study contact lists, study vendor contract tracking, site visit report completion, sample management).
• Update periodic clinical study and portfolio overview reports provided to senior management.
• Route and track approval forms for essential study documents (e.g., informed consent, study plans).
• Submit and track study agreements, contracts, budgets for assigned studies.
• Obtain/assign investigative site identification numbers.
• Request country-level clinical trial liability insurance certificates for assigned studies.
• Provide Regulatory Affairs with copies of 1572/Investigator Statement of Compliance and Financial Disclosures.
• Request study set-up in Veeva Vault and system access for study team members.
• Collaborate with eTMF Owner to draft and finalize the eTMF Plan and EDLS.
• Perform TMF filing, including reviews and reconciliation activities.
• Assign and track study-specific training for all Clin Ops team members.
• Manage off-site document storage and retrieval as applicable.
• Provide initial and ongoing study information in support of Clinical Trials.gov.
• Execute ad hoc study-related administrative tasks assigned by Study Lead.
• Assist in planning and coordination of meetings including logistics, agenda preparation and distribution of minutes.

Kenntnisse

Organizational skills

Attention to detail

Multi-tasking

Interpersonal skills

Written communication

Veeva eTMF

MS Outlook

Excel

DocuSign

Ausbildung

4-year college degree

Tools

MS Outlook

Excel

DocuSign

Veeva eTMF

Jobbeschreibung

Arrowhead Pharmaceuticals, Inc. in San Diego is seeking a detail-oriented Clinical Trial Associate to support Clinical Operations. The role focuses on administrative support, study tools, contract tracking, and regulatory document management to keep trials running smoothly.

You will coordinate with study teams, prepare study materials, and maintain the eTMF plan alignment with GDP/ICH-GCP standards. A 4-year degree and strong organizational skills are preferred in a fast-paced biopharma setting.