Clinical Research Associate I

Harmony Biosciences is recruiting for a Clinical Research Associate I in our Plymouth Meeting, PA location. In this role you will be responsible for independently monitoring clinical trial data in accordance with Good Clinical Practices (GCP), ICH, FDA, and internal standard operating procedures (SOPs). The CRA will conduct site visits to assess protocol and regulatory compliance while ensuring patient safety. This includes source document verification, regulatory document review and management, and drug accountability.

Responsibilities include but are not limited to:

• Review the performance of the trial at designated sites.
• Ensure the rights and well-being of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
• Ensure the quality and integrity of the reported data on case report forms (CRFs) by careful and thorough source documentation review. Generate queries and assist sites with resolution.
• Track and follow serious adverse events (SAEs) ensuring timely reporting to appropriate entities.
• Supports TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents.
• Reviews the completeness and quality of the investigator site file (ISF). Collects and reviews essential documents.
• Prepare accurate and timely trip reports while documenting visit findings.
• Assists in resolving any issues to ensure compliance. Escalating issues to the Study Manager as necessary.
• Maintain regular communication with sites.
• Conduct all aspects of site monitoring of clinical research studies according to Standard Operating Procedures, ICH Guidelines and GCP.
• Performs other related duties as assigned by management.

Qualifications:

• Bachelor's Degree in a Science related discipline required
• 2+ years' experience in sponsor study clinical research monitoring, or 2+ years' progressive experience in supporting the conduct and oversight of clinical trial activities required within a CRO; Therapeutic experience in neurology, preferred
• Familiarity with scientific methods, research design and clinical trials
• Working knowledge of Microsoft Office Suite, Microsoft Projects a plus

Physical demands and work environment:

• Domestic travel is estimated to be around 25 % 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.

What can Harmony offer you?

• 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 seven consecutive years based on our positive, values-based company culture

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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.

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