CLINICAL TRIAL ASSISTANT I – CTA

Clinical Trial Assistant I – CTA

Location: Redwood City, California

Category: Clinical Development and Operations

Salary: Apply for details

Country: United States

Employment: Contract

Worksite: On-Site

Apply For This Position

Job Description

The Opportunity: Clinical Trial Assistant I

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 into the Director (D) you will play a critical role in ensuring trials and studies align with all applicable standards.

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 prepare 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 assists with in-house drug, specimen, and ancillary supply reconciliation.
• Support other clinical operations activities as appropriate.
  
  

Required Skills, Experience And Education

• Bachelor’s degree in biological sciences or health-related field 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 Skills

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

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert

Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.