Clinical Trial Associate

Clinical Trial Associate

The Clinical Trial Associate will provide administrative support to the Clinical Operations Team in full spectrum of clinical trial activities related to study start up, study maintenance, study closure and vendor management in compliance with Good Clinical Practice (GCP), Standard Operation Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials.

The main responsibilities of this role include but not limited to the following:

• Supports with reviewing, formatting, and finalizing clinical protocols and other key study documents such as reports, Study Master ICF Template, etc.
• Provides administrative support with various tasks such as review and formatting of documents including follow-up on various tasks, updating project timelines, etc.
• Develop and maintain study tools and trackers (e.g., study contact lists, study vendor contract tracking, site visit report completion, sample management)
• Route and track approval forms for essential study documents (e.g., informed consent, study plans, etc.)
• Submit study agreements, contracts, budgets for assigned studies to the finance team Request country-level clinical trial liability insurance certificates for assigned studies
• Provide Regulatory Affairs with copies of the 1572/Investigator Statement of Compliance and Financial Disclosures
• Collaborate with eTMF Owner to draft and finalize the eTMF Plan and Expect Document Lists (EDLs)
• Oversee TMF filing, which may include reviews and reconciliation activities.
• Ensures correct filling of Site Essential Documents review during study start-up, maintenance, and close-out period
• Routinely participates in department and clinical trial team meetings and participates in collaborative efforts (e.g., protocol development, CRO selection, departmental initiatives, etc.)
• Review monitoring reports for clinical sites across all studies.
• Perform QEVs if necessary, at clinical sites.
• Provide initial and ongoing study information in support of clinical trial registration (e.g., Clinical Trials.gov)
• Execute ad hoc study-related administrative tasks assigned by Study Lead
• Recommend modifications to SOPs when necessary to improve compliance or efficiency.
• Comply with assigned SOPs and applicable plans, guidelines, and standards.
• In addition to Key Duties and Responsibilities
• May perform QC (formatting, spelling, grammar, accuracy, consistency) of study related documents (ICFs, study plans, etc.) in alignment with study protocols.
• May contribute to the development of study related documents (study plans, study templates, investigator site file materials, newsletters, etc.)
• May function as a point of contact between clinical vendors as delegated by Study Lead
• May participate in SOP development and revisions.
• Provides administrative support with various tasks such as review and formatting of documents including follow-up on various tasks, updating project timelines, etc.
• Other duties as assigned.

Requirements

• Bachelor's degree in a related or similar field
• Minimum of one-year relevant clinical trial experience in the pharmaceutical and/or biotechnology industry.
• Prior experience as a CTA and/or knowledge of FDA, ICH, GCP, CFR guidelines, regulatory requirements, and clinical trials operations.

Knowledge and Skills

• The scope of this position requires strong organizational, communication, and administrative skills including proficiency in Microsoft Office Suite such as Word, Excel, PowerPoint.
• Ability to oversee multiple tasks to meet deadlines in a dynamic environment is essential.
• Requires good organization, documentation, and interpersonal skills.
• Ability to work independently as well as within a collaborative environment.
• Strong attention to detail.

Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Salary Description

$60,000.00 - $70,000.00 annual salary