Clinical Trial Associate

Overview

Perceive Biotherapeutics is an exciting clinical-stage company, with a team focused on improving human health by developing breakthrough neuroprotective therapeutics that use novel approaches to treat highly prevalent, blinding diseases that currently have no good therapeutic alternatives. Perceive Bio brings together an experienced world-class team of leaders, scientists and drug developers. Our unique approach is a first-in-class and best-in-class gene therapy and small molecule therapeutics that will significantly impact patient’s lives.

We are looking for a talented individual to join our growing Clinical Operations team and contribute to the company’s long-term goals and success. The successful candidate will be thoughtful, collaborative, and possess the desire to learn, improve processes, and support key clinical stakeholders during our Ph 2 trials. This individual will be part of a highly collaborative and productive team and receive mentorship for professional growth.

Responsibilities

Context and Job Duties/Responsibilities:

This role is intended to support clinical trial execution in Ph 2 trials (as well as follow up and close-out of Phase 1 trials).  Specific responsibilities include:

• Administration of the Trial Master File (TMF):
• review of study, country and site documents for completeness and accuracy for inclusion into the TMF
• build structure and maintain the TMF
• evaluate progress through reports and reconciliations, determine gaps, follow up with internal and external stakeholders to ensure maintenance of the TMF
• Propose solutions to resolve/document TMF non-compliance
• Assist in the planning, organizing and execution of study-specific meetings and write and distribute agendas, minutes and regular updates.
• Maintain and update study team list including vendor contact information.
• Review and update system access user lists on regular pre-specified frequencies.
• May participate in reviewing, formatting and finalizing study-related templates, logs, plans and manuals.
• Maintain tracking of invoices.
• Assist with questions, issues or requests from the CRO/study team and route to the appropriate individual within the organization for resolution.
• Manage sample shipments to biorepository.
• May participate in data review, as required.
• Route, track and file Clinical documents and maintain organized internal files.
• Assist the Clinical Project Manager in site management activities. This could include review of monitoring reports, tracking of site visits, and assisting ICF review.
• Develop and maintain study-related trackers that will support Clinical Operations and individual studies.

Qualifications

Education, Experience, Capabilities and Knowledge:

A successful candidate for this role has an understanding of pharmaceutical clinical research and the requirements of a clinical operations function. 

• 4-year College Degree required in a biomedical or related clinical field.
• Knowledge of GCP, ICH, and clinical trial regulations
• At least 2 years of experience in the clinical research in the pharmaceutical / biotech / medical device industries at either a Sponsor or clinical CRO (i.e.—not academic or Investigator-sponsored only)
• Proactive, self-starter who possesses exceptional multi-tasking and communication skills, both oral and written.
• Vaccinated or willing to be vaccinated to meet requirements of entering clinical facilities, including vaccination for Covid-19 per CDC guidelines.
• Experience working in an ophthalmic clinical trial is preferred
• Previous on-site monitoring experience is preferred

Trainings and Skills

• Thorough knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials.
• Demonstrated ability to lead clinical projects to timelines and on budget, including detailed tracking, troubleshooting, and effective escalation with excellent planning and organizational skills.
• Demonstrated success in working with outside organizations/ groups/ vendors/ CROs.
• Strong project management skills.
• Critical thinking, productivity, and attention to detail
• Effective communication and collaboration
• High personal integrity and strong work ethic
• Leadership and Team Management
• Business acumen

Perceive Biotherapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

Please note that Perceive Bio will only collect personal information using a legitimate company email domain (@perceivebio.com) and will never offer payment or any financial transaction over text or email. Always verify that emails or other communications are directly from perceivebio.com.

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