Position Summary 

Reporting to the Director of Clinical Operations, the Clinical Trial Assistant supports clinical trials in rare bleeding disorders. This role is responsible for acting as a central contact for the clinical operations study team and assists with the clinical execution and management to support Star Therapeutics, Inc. clinical trials.  

 

Primary Responsibilities 

  • Assist in the development and review of study specific documents and reports (plans, training materials, study guides, manuals etc.) 

  • Support Standard Operating Procedure (SOP) development and review of clinical data in the Electronic Data Capture (EDC) system  

  • Support gathering investigator and site information, to enable study start-up, maintenance and close out activities 

  • Support monitoring visit report review, review of protocol deviations.  Lab sample tracking reconciliation 

  • Assist with updating and maintaining clinical systems and tools 

  • May assist with the set up and maintenance of the trial master files (TMF) if applicable, or work with CRO to audit and resolve discrepancies 

  • Assist with the development of standard processes, tracking and documentation of information for key study related activities 

  • Assist in the preparation of meeting materials and agendas, taking meeting minutes for internal clinical operation team meetings 

  • Work with cross functional study teams, and vendors to assist in the coordination of clinical trial activities 

  • Support other clinical operations activities as needed 

 

Requirements 

  • Working knowledge of ICH GCP 

  • Excellent planning, organizing, problem-solving and execution skills with the ability to multi-task and prioritize 

  • Excellent interpersonal, verbal and written communication skills  

  • Demonstrated proficiency in Microsoft Word, Excel and PowerPoint 

  • Up to 10% travel may be required  

 

Education & Professional Experience 

  • RN or B.S. degree in biological sciences or related health related field required. 

  • Minimum of 1-2 years relevant experience in the pharmaceutical or biotech industry, preferably in clinical operations. 

 

 

Salary Range  

The hiring salary range for candidates residing in California for this position is $55,400 to $73,000 annually.  This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation geographic location, individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.  This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.  

 

*Please note the preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive listing of all activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

 

Star Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  Star is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.