Clinical Operations Associate

Job Summary:

To support Clinical Operations compliance by tracking and maintaining information in various systems.

Essential Duties & Responsibilities

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  Oversee site payments for clinical studies managed internally by Clinical Operations Team.
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  Process purchase orders in conjunction with site payments and assist with monthly accruals information as requested by Finance personnel.
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  Serve as the primary contact for sites regarding payment inquiries.
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  Oversee the development, maintenance, and reconciliation of the (Electronic) Trial Master Files ensuring each (e)TMF is ICH, GCP and 21 CFR 11 compliant (when applicable).
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  Monitor (e)TMFs for accuracy and completeness; correspond with internal staff, CRO’s and (e)TMF vendors to ensure documents are uploaded timely and efficiently in accordance with each TMF Plan.
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  Assist study team personnel with collecting, tracking and providing Regulatory Affairs with regulatory documents during the course of each clinical trial.
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  Collaborate with Clinical Document Management to assist with revisions of department SOPs.
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  Assist with revision of (e)TMF structure to align with the DIA Reference Model.
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  Triage study-specific information to Clinical Operations team members who are traveling.
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  Facilitate requests for clinical documentation.
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  Assist with data entry and maintenance of both R&D Vendor and Publication Repositories.
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  Assist with receiving and inputting of data for Sunshine Act Reporting.
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  Assist in the tracking of study activities and metrics as needed.
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  Work collaboratively and effectively with a multitude of people.
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  Attend and participate in internal and external training sessions.

Non-Essential Duties & Responsibilities:

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  N/A

Supervisory Responsibilities:

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  N/A

Knowledge & Other Qualifications:

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  Bachelor’s Degree with 4+ years of work experience preferred. Will consider 6 years of equivalent experience.
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  Excellent organizational, multitasking, and problem solving skills with exceptional attention to detail.
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  Excellent interpersonal and communication skills in English language (writing, speaking, and comprehending).
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  Proficiency with computers and Microsoft Office Suite including Word, Outlook, Excel, Acrobat, and strong focus in Access.
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  Experience in therapeutic areas of CNS or psychiatry a plus.
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  Familiarity with regulations governing clinical research and ICH GCP guidelines a plus.

Other Characteristics:

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  Willing and able to travel.
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  Ability to work independently and as part of a team.
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  Able to maintain high ethical standards of integrity and quality.
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  Capable of being innovative and dynamic in approach to work.
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  Capable of performing other duties as assigned by management.
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  Authorized to legally work in the United States without visa sponsorship.

Physical Requirements / Work Environment

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  Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
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  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
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  The worker is not substantially exposed to adverse environmental conditions

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.