Job Title: Clinical Trial Associate
Reports To: Director, Clinical Operations
Functional Area: Clinical Operations
Position Location: Remote (possible hybrid)
Exempt/Non-Exempt: Exempt
About Tourmaline Bio, Inc.
We are a late-stage clinical biotechnology company with a nimble, driven and accomplished team of entrepreneurs, physicians, and industry experts on a mission to thoughtfully develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Our core values help drive this mission and are the foundation of our company culture: we have a passion for our mission; we believe respect and inclusion are core to the success of our team; we overcome obstacles to deliver results for patients; and we push the envelope.
Our lead asset is pacibekitug (also known as TOUR006), a long-acting, fully-human, anti-IL-6 monoclonal antibody. Pacibekitug has previously completed multiple Phase 1 and Phase 2 clinical trials. Tourmaline is developing pacibekitug in atherosclerotic cardiovascular disease (ASCVD), abdominal aortic aneurysm (AAA) and thyroid eye disease (TED). More information about Tourmaline and pacibekitug can be found at www.tourmalinebio.com.
General Responsibilities:
We are seeking a motivated and detail-oriented Clinical Trial Associate (CTA) to join our growing Clinical Operations team. The CTA will support the clinical trial execution team from planning through execution, ensuring that all activities comply with Good Clinical Practice (GCP) and regulatory requirements. They will collaborate closely with cross-functional teams, external vendors, and clinical investigators, using critical thinking and problem-solving skills to ensure that clinical trials are conducted efficiently and effectively.
Responsibilities:
- Assist in all operational aspects of the assigned clinical trial(s) from study start-up to closeout
- Assist in review of study-associated and essential clinical start-up documents
- Assist in eTMF documentation filing and reviews
- Assist in data review and/or preparation for data cuts
- Schedule activities and meetings, including taking/distributing meeting agendas and minutes, compilation of materials, providing updates and overseeing presentations
- File and route agreements related to Clinical Operations
- Create, distribute and update trackers for metric reporting (e.g. sample tracking, enrollment tracking, study documentation tracking)
- Apply analytical thinking to assess study progress, analyze key performance indicators (KPIs), and identify potential gaps/risks
- Assist with preparation of reports and/or requests as required
- Support departmental initiatives and process improvements
- Maintain awareness of study events and associated documentation requirements through collaboration with functional/sub-functional area study team members
- Track critical trial-related documents and processes
- Apply proactive communication, prioritization, and a solution-oriented mindset to the completion of assigned tasks
- Other duties and responsibilities as required
Education and Licensure:
- Bachelor’s degree required.
Experience and Attributes
- A minimum of two years relevant industry experience as a CTA, sponsor experience strongly preferred.
- Experience in a CRO, sponsor or clinical research administration function, including hands on experience relating to the essential documentation of a clinical trial.
- Thorough understanding of clinical research principles and process.
- Thorough understanding of ICH GCP guidelines and regulatory requirements.
- Motivated self-starter with a strong work ethic and the ability to work well in a team environment.
- Excellent interpersonal, oral and written communication skills.
- Excellent planning and organizational skills with effective time management.
- Demonstrate initiative and problem-solving skills by offering solutions when obstacles are identified.
- Thrive in a fast-paced and evolving environment.
- Must be able to prioritize tasks with attention to detail, plan proactively, and accomplish goals with specified time frames according to company standard operating procedures.
- Ability and willingness to travel domestically and internationally (~15%).
Base Salary Range:
$84,000 – $101,000 based on candidate professional experience level.
Note:
This job description is written as a guideline to inform a current or prospective Tourmaline employee of what is or will be generally expected in a given position. The description is not intended to be all-encompassing or limiting in any manner. Duties and responsibilities other than those listed above may be included as needed.
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Tourmaline Bio, Inc. is proud to be an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other protected characteristics under applicable law.
