Sr. Clinical Trial Assistant / Clinical Trial Management Associate at Bayside Solutions San Mateo County, CA

(s), supporting the execution and management of clinical trials. You will ensure 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) Guidelines.
• Assist in developing, reviewing, distributing, and archiving study-specific documents and reports (e.g., essential documents, plans, training materials, study guides, manuals, etc.)
• Support 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.
• Track and prepare study-specific information utilizing databases, trackers, and other study tools.
• Assist in preparing 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.
• 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 coordinate clinical trial activities.
• Liaise with Clinical Supply and other cross-functional teams to process shipments and returns and assist with in-house drug, specimen, and ancillary supply reconciliation.
• Support other clinical operations activities as appropriate.

Requirements and Qualifications:
• Bachelor's degree in biological sciences or a health-related field is required.
• 1-5 years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience
• 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 and verbal communication and interpersonal skills
• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
• Strong attention to detail.
• Travel may be required (~10%)
• Familiarity working with vendor systems/portals (eTMF, EDC, IRT, CTMS) is a plus.
• Oncology experience is preferred.

Desired Skills and Experience

Clinical Operations, Clinical Research, SOP, GCP, ICH Guidelines, TMF, CRO, Microsoft Office, Oncology, travel

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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