Job Title: Lead Clinical Research 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 nimble, driven and accomplished team of entrepreneurs, physicians, and industry experts with 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 program has completed multiple Phase 1 and Phase 2 clinical trials. We launched our Phase 2b clinical trial in Thyroid Eye Disease (TED) in 2023 and our Phase 2 clinical trial in cardiovascular disease in Q2 2024. We plan to initiate our Phase 3 clinical trial in TED later in 2024. More information about Tourmaline can be found at www.tourmalinebio.com.
General Responsibilities:
The Lead Clinical Research Associate (Lead CRA) provides support for study management tasks in collaboration with the Senior Clinical Trial Manager and Clinical Operations leadership, with an emphasis on leading monitoring oversight activities for our clinical CROs. The Lead CRA works with Clinical to ensure that protocol requirements, laboratory collections, regulatory requirements, and relevant clinical research guidelines are adhered to, and that project timelines are met.
Responsibilities:
- Create CRA training materials and ensure the CRO CRAs are adequately trained and are prepared to train the study site staff
- Review monitoring visit reports (MVRs) from the CRO
- Monitor studies or perform co-monitoring visits as required per the Sponsor Oversight Plan or as needed
- Develop and monitor metrics to evaluate the CRO CRAs and site performance and ensure compliance with the study protocol, monitoring plan, SOPs, ICH-cGCP guidelines, and relevant laws and regulations
- Ensure the Trial Master File is maintained in an inspection-ready state at the CRO. Review for compliance and address findings, as needed
- Oversee clinical trial site setup and activation activities
- Assist the Senior Clinical Trial Manager in the review of Informed Consent Forms and other essential study documents
- Assist with planning for and actively participate in investigator meetings
Education:
- Bachelor’s degree is required
- Certification as a Clinical Research Associate or Clinical Research Professional is highly desirable
Experience and Attributes:
- 5+ years clinical trial site monitoring experience in a biotech, pharmaceutical and/ or CRO company
- Experience overseeing CRO CRAs
- Good understanding and working knowledge of clinical research and phases of clinical trials
- Good understanding of and ability to work in accordance with current GCP/ICH guidelines and relevant clinical research laws and regulations
- Highly organized, outcome-oriented, self-motivated performance
- Ability to adapt to change in a growth environment
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
- Strong written and oral communication skills
- Knowledgeable of Electronic Data Capture and other IT systems (CTMS, Microsoft Office, etc.)
- Periodic travel to Tourmaline office in New York is required
- Ability and willingness to travel to domestically and internationally (up to 10%)
Base Salary Range:
$125,000 – $155,000, 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.
