Job Summary:  

The Senior Clinical Research Associate (CRA) is a critical member of the clinical operations team, responsible for ensuring the successful execution of clinical trials from initiation to completion. This role involves managing the operational aspects of clinical studies, including site selection, monitoring, case report form (CRF) review, and ensuring clinical trial compliance with regulatory requirements. The Senior CRA serves as a primary point of contact between ‘and study site personnel.

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Essential Duties & Responsibilities:

Contributes to the development and review of study-related materials including CRFs, protocols, informed consent forms, and monitoring plans. Assists in the development of subject recruitment strategies and materials. Serves as a point of contact for CROs and study site personnel to answer questions and resolve any study-related issues. Manages and leads internal meetings with different core functional teams. Manages study vendors, ensuring compliance to the Statement of Work (SOW), and established protocols. Mentors junior level Clinical Research Associates. Serves as the primary counterpart of CRO lead monitor, if outsourced, and reviews/approves monitoring reports. Proactively identifies project issues and contributes to problem resolution. Ensures that all visits are conducted according to Food and Drug Administration (FDA)regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, and company Standard Operating Procedures (SOPs). Ensures adequate reporting of study status, protocol deviations, and subject status. Identifies areas requiring follow-up and improvement at each clinical study site. Performs regular reviews of data entered by the study site staff according to data review/monitoring guidelines. 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. Prepares and attends project team meetings, provide updates on project status and site-specific performance. Works collaboratively and effectively in an internal project team and outsourced environment. Contributes to the preparation of investigator meetings and clinical study presentations.

 

.Supervisory Responsibilities:

N/A

 

Knowledge & Other Qualifications:

Bachelor’s degree in chemistry, Biology, or related field with four years of relevant experience is required. Previous experience working in Central Nervous Systems or Epilepsy therapeutic areas and Clinical Research Associate (CRA) Certification is a plus. Understanding of Clinical Trial Operations, Code of Federal Regulations, Good Clinical Practice, and ICH E6. Strong organizational skills with attention to detail and an ability to multi-task. Excellent interpersonal and communication skills In English (written, speaking, and comprehension). Excellent computer proficiency of Microsoft Office package including Word, Outlook, and Excel.

 

Other Characteristics:

Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. Ability of having an innovative and dynamic approach to work. A self-starter able to work independently but comfortable working in a team environment. Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others. Capable of performing other duties as assigned by Management. Authorized to legally work in the United States without visa sponsorship.

 

Physical Requirements/Work Environment/Travel Requirements:

Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. The worker is not substantially exposed to adverse environmental conditions.

 

Compensation:

At Supernus, we offer a competitive compensation package that reflects your experiences and contributions.  The expected salary range for fully qualified candidates applying for this role is $85,000 to $105,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual’s salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.  

Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs.

 

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.