What are the responsibilities and job description for the Clinical Trial Assistant position at Harmony Biosciences?
Harmony Biosciences is recruiting for a Clinical Trial Assistant in our Plymouth Meeting location. In this role you 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. The CTA will help ensure clinical trial processes, documentation, and communications are completed accurately, efficiently, and in compliance with applicable regulations, Good Clinical Practice (GCP), and company procedures.
Responsibilities include but are not limited to:
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. For more information on Harmony Biosciences, visit www.harmonybiosciences.com
Harmony Biosciences is 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.
Recruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
Responsibilities include but are not limited to:
- Provide general administrative support to the study team
- Support the Clinical Operations team with ongoing conduct of studies
- Assist study teams with study specific documentation and guidelines as appropriate
- Set up, organize and maintain clinical study documentation
- Process Data Collection Forms i.e. log in, tracking, 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, as needed for project, departmental, 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, invoice reconciliation
- Responsible with review of regulatory documents
- Performs other related duties as assigned by management
- Prepare and distribute study-related communications, agendas, meeting minutes, and reports
- 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)
- Domestic travel is estimated to be around 15% of the time for this position.
- While performing the duties of this job, the noise level in the work environment is usually quiet.
- The employee must occasionally lift and /or move more than 20 pounds.
- Specific vision abilities required by this job include: Close vision.
- Manual dexterity required to use computers, tablets, and cell phone.
- Continuous sitting for prolonged periods.
- 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
- A certified Great Place to Work® for eight consecutive years based on our positive, values-based company culture
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. For more information on Harmony Biosciences, visit www.harmonybiosciences.com
Harmony Biosciences is 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.
Recruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.