Job Title: Clinical Trial Associate
Reports To: Senior Clinical Trial Manager
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 thyroid eye disease (TED) and atherosclerotic cardiovascular disease (ASCVD) as its first two indications, with additional diseases under consideration. More information about Tourmaline and pacibekitug can be found at www.tourmalinebio.com.
General Responsibilities:
The Clinical Trial Associate (CTA) will function in a key supporting role for the clinical team in all administrative aspects of the clinical projects assigned in accordance with good clinical practices (GCP) and regulatory authority guidance to ensure the efficient conduct of clinical trials. The Clinical Trial Associate will support all operational aspects of study management from start-up through closeout.
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 data review and/or preparation for data cuts.
- Participate in training CRO and vendors (e.g., Central Lab, Imaging, etc.).
- Participate in study team meetings and provide regular study updates.
- Responsible for tracking patient enrollment, lab samples, study activities, etc.
- Support other studies as required and other duties as assigned.
- Maintain awareness of study events and associated documentation requirements through collaboration with functional/sub-functional area study team members.
- Distributes, collects, and tracks large amounts of documentation accurately and within project timelines.
- Filing and routing of agreements related to Clinical Operations.
- Scheduling activities and setting up virtual meetings, including compilation of materials and overseeing presentations.
Education:
- 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.
