Clinical Research Associate

Clinical Research Associate

Reporting to: Senior Director, Clinical Operations

Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear and profound impact on patients suffering from rare diseases? Does it excite you to be a part of a patient-focused company developing potential new treatments that could dramatically improve the lives of patients with limited to no current treatment options? If yes, we encourage you to share with us your aspirations and career goals.

X4 is focused on restoring healthy immune system function by developing novel therapeutics to treat chronic neutropenic disorders, including WHIM syndrome, a rare primary immunodeficiency. We are advancing a novel, late-stage clinical candidate, mavorixafor, that we believe has the potential to become a new standard of care for patients with these disorders. We know that developing innovative, new medicines is challenging, and we invite new colleagues who share our values and commitment to join us in achieving our mission.

This opportunity will

• Align with your values and grit, and passion for innovative science.
• Leverage your knowledge of Clinical Operations to support our innovative science and allow you to have a major impact on our mission to support our patients.
• Offer a collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity.

Accountabilities and Responsibilities:

The Clinical Research Associate is a crucial internally and externally facing role responsible for collaborating with various stakeholders and supporting the quality delivery and oversight of X4 clinical trials.

• Collaborate with clinical trial sites and third-party vendors to ensure adherence to protocol(s) and study requirements; may include monitoring and co-monitoring responsibilities.

• Review documents for completeness, accuracy, and compliance with protocol and appropriate regulations; Identify issues and take appropriate corrective actions.

• Support sites in strategy for identification and screening of potential study participants, maintenance of appropriate documents for conduct of study at the site, and follow through on issues.

• Contribute to the creation and review of study-specific plans, specification documents, materials, and tools.

• Assist in preparing study-related documents (i.e., ICF, clinical trial tools, templates, training materials, manuals, study newsletters, etc.).

• Deliver and execute operational tasks, and assist in tracking study metrics, maintenance, and distribution of study trackers.

• QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert acknowledgments, ICFs, and timelines.

Requirements: Proven Experience, Skills, and Education:

• Bachelor's degree required.
• Minimum of 2-5 years of experience in the biotech or pharmaceutical industry, with at least 2+ years direct experience as a Clinical Research Associate/Monitor.
• Working knowledge of ICH GCP regulations and clinical protocols.
• Demonstrated effectiveness in resolving complex site management issues.
• Requires exceptional attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines.
• Sound analytical and problem-solving skills; ability to act with a sense of urgency.
• Ability to work in a fast-paced environment with demonstrated agility to juggle multiple competing tasks and demands.
• Excellent written and verbal communication skills.
• Team player that takes initiative and is willing to support optimizing the way we work.
• This position requires up to 50% travel.

This position offers a flexible location within the United States due to travel. If based in the Boston area, this position offers a flexible hybrid work model with a minimum of 2 days/week in the office.

We encourage you to learn more about X4 Pharmaceuticals. Click on the links below!

About Us

Pipeline

X4 Pharmaceuticals is an Equal Opportunity, and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law.

Please note that effective January 1, 2022, as a condition of employment at X4 Pharmaceuticals, all employees and new employees must have received their complete doses of the COVID-19 vaccine and one booster unless they have been granted an exemption by X4.

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