Clinical Trial Specialist

PRIMARY ROLE

We are seeking a dedicated and highly organized Clinical Trials Specialist to join our team. This role will be responsible for overseeing and executing strategies to recruit and retain patients for clinical trials across various therapeutic areas. The ideal candidate will be adept at building relationships with patients, healthcare providers, and internal stakeholders to ensure successful recruitment and retention efforts. In addition, the role is responsible for creating, distributing, maintaining, and organizing study materials, tools, and documents to ensure conduct of clinical trials is in compliance with protocol requirements, SOPs, and ICH guidelines.

DUTIES & RESPONSIBILITIES

Strategic Recruitment Planning:

• Collaborate with study teams, investigators, and sponsors to define recruitment objectives.
• Develop, implement, and monitor recruitment strategies tailored to specific trial protocols.
• Support clinical sites in developing recruiting strategies, implement novel approaches to recruitment, and oversee their progress towards recruitment.
• Leverage data-driven insights to optimize patient outreach and engagement campaigns.

Participant Engagement:

• Identify and engage potential trial participants through digital platforms, healthcare networks, and community outreach.
• Educate patients on clinical trial participation benefits, risks, and procedures while addressing any concerns.
• Maintain consistent communication with enrolled participants to ensure retention and compliance.

Collaboration with Stakeholders:

• Partner with site coordinators, clinical investigators, and patient advocacy groups to facilitate recruitment efforts.
• Serve as a liaison between sponsors and recruitment vendors to ensure alignment on goals and timelines.
• Work closely with Clinical Study Team to ensure completeness and accuracy of eISF and eTMF
• Engage in various support activities like User Acceptance Testing (UAT), tracking inventory, and facilitating postings to Clinicaltrials.gov.

Marketing and Outreach Initiatives:

• Design and execute recruitment campaigns using traditional and digital marketing tools.
• Develop promotional materials such as brochures, social media posts, and email campaigns.
• Organize community events and webinars to raise awareness of clinical trial opportunities.

Compliance and Documentation:

• Adhere to ethical standards and regulatory guidelines, including GCP, HIPAA, and FDA requirements.
• Ensure accurate documentation of recruitment activities, including prescreening and eligibility assessments.
• Prepare progress reports on recruitment metrics and suggest adjustments as needed.
• Various tasks such as organizing study files, tracking inventory and supplies, and coordinating document translations
• Maintain study documentation, track essential documents, and ensure the TMF (Trial Master File) is complete and well-maintained.

Budget Management:

• Monitor recruitment budgets and track the cost-effectiveness of recruitment efforts.
• Ensure recruitment strategies are executed within budget, while optimizing spend on recruitment tools and resources, including vendor invoices and investigator payments

LOCATION

Onsite preferred with 25% travel

(will consider remote candidates with the appropriate experience)

SALARY
$80,000-$115,000 (Depending on qualifications and experience level)

QUALIFICATIONS

Required Skills/Abilities:

• Minimum of 2-3 years of relevant experience in clinical trial patient recruitment, clinical research, or healthcare administration; or Master's degree with 1 year of experience.
• Proven track record in developing and executing successful patient recruitment strategies across various therapeutic areas.
• Experience working with digital recruitment tools, social media platforms, and other modern marketing strategies to drive patient enrollment.
• Strong interpersonal and communication skills, with the ability to engage with diverse patient populations.
• Familiarity with regulatory submission processes is desirable.

Education and Experience:

• Bachelor's degree in Life Sciences, Nursing, Public Health, or a related field (or equivalent experience). A Master's degree is a plus.

Alto Neuroscience, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, religion, marital status, sexual orientation, gender identity, pregnancy, disability, or any other characteristic protected by law.