To monitor clinical study sites to ensure compliance with the clinical trial protocol, to check clinical site activities, to make on-site visits, to review Case Report Forms (CRFs) and to communicate with clinical research investigators.
Essential Duties & Responsibilities:
Non-Essential Duties & Responsibilities:
- Assists with the development and/or review of study-related materials including case report forms (CRF), protocols, informed consent forms, monitoring plan, etc.
- Participates in the identification and recruitment of investigators, and assists in the development of subject recruitment strategies and materials.
- Prepares for and conducts site qualification, initiation, interim monitoring, and close-out visits at study sites.
- Ensures that all visits are conducted according to FDA regulations, ICH guidelines, and company standard operating procedures.
- Ensures adequate reporting/tracking of adverse events, protocol deviations, and subject status.
- Identifies areas requiring follow-up and improvement at each clinical study site, and recommend and implement corrective action.
- Serves as primary point of contact for study site personnel to answer questions and resolve study-related issues.
- Confirms that data recorded on CRF are accurate, complete, and verifiable against source documents.
- Oversees collection of regulatory documents required for CTM shipment clearance. Ensures proper maintenance of required essential documents at the site level. Assists with set-up, maintenance, and reconciliation of Trial Master File.
- Provides updates on project status and site-specific performance to the Study PM.
- Assists with overseeing CRO’s and other study vendors, including co-monitoring external CRO monitors.
- Works collaboratively and effectively in a project team outsourced environment.
Knowledge and Other Qualifications:
- Attends and participates in internal and external training sessions.
- 0+ years of experience with a Bachelor’s degree in a related scientific discipline and/or Registered Nurse Preferred
- 3+ years of relevant experience with High School Diploma considered.
- One year of industry experience preferably in clinical research a plus.
- Experience in therapeutic areas of CNS or psychiatry a plus.
- Understanding of regulations governing clinical research (i.e., FDA, Health Canada), and ICH GCP guidelines.
- Strong organizational skills with attention to detail.
- Excellent interpersonal and communication skills in English language (writing, speaking, and comprehending).
- Excellent computer proficiency of Microsoft Office package including Word, Outlook, and Excel. Access is a plus.
- Willing and able to travel up to 50%, or greater depending on project needs, but should not exceed 75%.
- Able to work independently and as part of a team.
- Able to maintain high ethical standards of integrity and quality.
- Capable of being innovative and dynamic in approach to work.
- Capable of performing other duties as assigned by management.
- Authorized to legally work in the United States without visa sponsorship.
Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.