CTA / TMF Contractor

Reports To: Sr Director, Clin Ops

Department: Clin Ops

Location: SSF Office / Hybrid / Remote

 

 

ABOUT THE JOB

Reporting to the Sr. Director of Clinical Operations, the CTA / TMF Contractor 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. The primary focus of this role will be working on Trial Master Files.

OUR CORE VALUES

The below core values drive all that we do here at Star.  We are looking for like-minded individuals that feel passionately about these same values to join our team.

  • Patients are our Center of Gravity: We partner with patients in unique ways, to uncover and address their unmet needs.
  • Propelled by Data, Guided by Intuition, Informed by Expertise: We boldly explore new diseases, novel biology, and smart ways of working with a sense of urgency.
  • Mission Ready Crew: With courage and agility, we opportunistically challenge conventional wisdom and foster an environment of respect and continuous growth.

RESPONSIBILITIES

  • Support Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs) in daily trial operations.
  • Manage the set up and maintenance of the trial master files (TMF) and work with CRO to audit and resolve discrepancies
  • 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
  • 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

 

EDUCATION, EXPERIENCE & QUALIFICATIONS

  • RN or B.S. or M.S. degree in biological sciences or related health related field required.
  • Minimum of 3-5 years relevant experience in the pharmaceutical or biotech industry, in clinical operations.
  • Strong 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 with a proactive and team-oriented mindset
  • Ability to work in a fast-paced, evolving environment with a willingness to take initiative.
  • Demonstrated proficiency in Microsoft Word, Excel and PowerPoint
  • Up to 10% travel may be required

 

ABOUT STAR THERAPEUTICS

Star Therapeutics is a Phase 3 clinical stage biotechnology company that aims to discover and develop best-in-class antibody therapies to transform the lives of patients with serious diseases. Founded by former True North executives, Star has built a team with significant scientific, clinical, regulatory, and commercial experience that has a demonstrated track record of success and is backed by top-tier biotech investors.  We pride ourselves on our collective passion in bringing innovative therapies to the clinic and are committed to patients for whom no or limited treatment options exist.

Star is headquartered in South San Francisco, CA.  More information about Star can be found on our website at www.star-therapeutics.com.

We are an equal opportunity employer and value diversity at our company.  We do not discriminate on the basis of race, religion, color, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status.

We anticipate the hourly pay for the CTA/TMF Contractor position in our South San Francisco, CA office to range from $50 to $70 per hour and will depend on current market data and the candidate’s qualifications for the role, including education, experience and geographic location.  The compensation described above is subject to change and could be higher or lower than the range described based on several factors.

Qualified candidates should apply via our careers page at: https://star-therapeutics.com/our-careers/

NO PHONE CALLS or AGENCIES, please.

Note to External Recruiters: Submission of unsolicited resumes prior to an agreement set in place does not create any implied obligation.