Clinical Trial Associate (CTA)

Description

The Company:

Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality.

The company assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices.

The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

Position Summary

This position reports to the Director of Clinical Operations and will be responsible to execute delegated responsibilities related to trial start up, execution, and close out to expected and specified quality standards. The CTA will also ensure all trial related activities are in compliance with SOPs, policies, and regulatory requirements.

Responsibilities

• Provide general administrative support to the Clinical Operations Department and assistance to Clinical Study Manager(s).
• CTA supports clinical studies and the Clinical Operations Department in managing various administrative tasks such as the generation of agendas and minutes, maintaining study tracking, and correspondence with the IRB as necessary.
• Assists the Clinical Study Manager(s) with CRO/vendor oversight, study-specific documentation review and QC, including review of protocol, ICF, study plans, study reference manuals, case report forms (CRF), etc.
• CTA will play a key role in assisting Document Management with implementing TMF (trial master file) specifications, ensuring they align with the program milestones.
• The CTA will assist in document filing in the electronic TMF and quality reviews.
• CTA will participate in continuous improvement opportunities and enhance operational efficiency actively.
• Assists with customization of CDA, clinical site contracts & budgets, when applicable.
• Assist the Clinical Study Manager(s) and Clinical Operations Team with Investigator Meeting coordination, activities preparation and generation of meeting minutes.
• Coordinate document translations, if required.
• May participate in training CRO/vendor teams and onboarding new team members.
• Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc. when requested).
• May assist in the request of study supply materials and shipments for sites and subjects as needed.
• May work with the study team, CRA team and sites to collect documents and maintain files.
• Attends internal and external team meetings/teleconferences and generates meeting agendas and minutes when needed.
• Assists in maintaining training files for study team, as needed.
• Other duties may be assigned as required.
  
  

Requirements

Education/Experience

• A minimum of a Bachelor's degree.
• A minimum of 3 years of pharmaceutical drug development and clinical operations.
• Knowledge of the drug development process, International Council for Harmonisation-Good Clinical Practices (ICH-GCP), Good Documentation Practices (GDP), SOPs and compliance with FDA Code of Federal Regulations is required.
  
  

Additional Skills

• Experience mentoring/coaching and providing training to others is preferred.
• Strong computer skills in appropriate software applications (Microsoft Office, email, audio/video conferencing tools) and related clinical systems required. Knowledge of MS project preferred but not required.
• Must have a flexible mindset with the ability to work in a fast-paced environment.
• Must have strong written and oral communication and organizational skills.
• Must be highly motivated and have a solution-oriented and problem-solving attitude.
• Ability to travel to the office for meetings as required.
  
  

Benefits

Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.

We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.

Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner—without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.

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