Clinical Trial Assistant

Clinical Trial Assistant

W2 Contract-to-Hire

Pay Rate: $50 - $60 per hour

Location: Redwood City, CA - Hybrid Role

Job Summary:

This is a unique opportunity for an entry-level Clinical Operations Professional. As a Clinical Trial Assistant I (CTA I), you will be responsible for acting as an integral member of the clinical study team(s) and will be tasked to support the execution and management of clinical trials. Reporting to the Director (D), you will play a critical role in ensuring trials and studies align with all applicable standards.

Duties and Responsibilities:

• Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) Guideline
• Assist in the development, review, distribution, and archiving of study-specific documents and reports (e.g., essential documents, plans, training materials, study guides, manuals, etc.).
• Will lead the set-up and maintenance of the trial master files (TMF), if applicable, and work with the contract research organization (CRO) to audit and resolve discrepancies.
• Assist project team(s) with sample management and generate trial progress tracking systems.
• Tracks and prepares study-specific information utilizing databases, trackers, and other study tools.
• Assist in the preparation of meeting materials, including scheduling, developing agendas, and minute-taking for internal study team meetings.
• Gather investigator and site information to support study start-up, maintenance, and close-out activities.
• Assist in contacting investigator sites to provide study-specific information.
• May serve as the point of contact for study sites and study monitors for clinical supplies, document collection, and preparation for close-out visits.
• Work with cross-functional study teams and vendors to assist in the coordination of clinical trial activities.
• Liaise with Clinical Supply and other cross-functional teams with processing shipments, returns, and assist with in-house drug, specimen, and ancillary supply reconciliation.
• Support other clinical operations activities as appropriate.

Requirements and Qualifications:

• A bachelor's degree in biological sciences or a health-related field is required.
• 1-3 years relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.
• Has knowledge of GCP ICH Guidelines.
• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Excellent written/verbal communication and interpersonal skills.
• Demonstrate proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
• Travel may be required (~10%).

Preferred Qualifications:

• Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
• Oncology experience preferred.
• Attention to detail.

Desired Skills and Experience

Clinical trial support, Clinical operations, Clinical research, Good Clinical Practice (GCP), ICH guidelines, Clinical SOP compliance, Trial Master File (TMF) setup and maintenance, eTMF systems, CRO collaboration and oversight, Study document development and archiving, Essential document management, Study start-up, maintenance and close-out activities, Investigator and site communication, Site management support, Clinical supply management, Drug and specimen reconciliation, Sample management, Trial progress tracking, Database and tracker management, Meeting coordination and minute-taking, Cross-functional team collaboration, Vendor management and coordination, EDC systems, IRT systems, CTMS, Microsoft Office Suite (Outlook, Word, Excel, PowerPoint), MS Project, Smartsheet, Oncology clinical trials, Regulatory compliance, Detail-oriented, Written and verbal communication skills

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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