Clinical Trial Assistant

About the role

The Clinical Trial Assistant (CTA) will provide administrative, operational, and project support to Clinical Operations and cross-functional teams involved in the planning and execution of clinical trials. This role will assist with study start-up activities, site and vendor documentation, trial master file (TMF) maintenance, enrollment tracking, study conduct oversight, and study close-out activities.

Responsibilities

• Provide general administrative support to the study team
• Support the Clinical Operations team with ongoing conduct of studies
• Aid study teams with study specific documentation and guidelines as appropriate
• Set up, organize, and maintain clinical study documentation
• Process Data Collection Forms, including logging, tracking, and quality control as appropriate for the study
• Assist in quality control audits of clinical study documentation and inspection readiness activities
• Contribute to the production and updates of slides for project, departmental, and sponsor presentations
• Maintain clinical trial files (including review of eTMF), tracking systems, and other study or departmental systems
• Responsible for vendor and clinical site agreements, budget tracking, and invoice reconciliation
• Review regulatory documents
• Perform other related duties as assigned by management
• Prepare and distribute study-related communications, agendas, meeting minutes, and reports

Qualifications

• Bachelor's degree in Life Sciences, Biology, Healthcare, or a related scientific discipline required
• Relevant experience gained through internships, co-op programs, academic research, clinical research, healthcare, or other related environments preferred
• Basic understanding of clinical research, scientific methods, and clinical trial processes preferred
• Strong organizational skills with attention to detail and the ability to manage multiple priorities
• Effective written and verbal communication skills
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)

Benefits

• Medical, Vision, and Dental benefits the first of the month following start date
• Generous paid time off and Company designated Holidays
• Company paid Disability benefits and Life Insurance coverage
• 401(k) Retirement Savings Plan
• Paid Parental leave
• Employee Stock Purchase Plan (ESPP)
• Company sponsored wellness programs
• Professional development initiatives and continuous learning opportunities
• Certified Great Place to Work® for eight consecutive years based on our positive, values-based company culture

What can Harmony offer you?

• Medical, Vision, and Dental benefits
• Generous paid time off and Company designated Holidays
• Company paid Disability benefits and Life Insurance coverage
• 401(k) Retirement Savings Plan
• Paid Parental leave
• Employee Stock Purchase Plan (ESPP)
• Company sponsored wellness programs
• Professional development initiatives and continuous learning opportunities
• Certified Great Place to Work® for eight consecutive years based on our positive, values-based company culture

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Harmony Biosciences

Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs.

Equal Opportunity Employer

We are an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.