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Clinical Research Associate ll

Rockville, MD
  • Expired: February 10, 2023. Applications are no longer accepted.
Job Summary:

To assist with overseeing clinical trial progress and vendors, to contribute to internal documentation and communication, to ensure compliance with the clinical trial protocol, to check clinical site activities, to review Case Report Forms (CRFs) and to communicate with clinical research investigators.

Essential Duties & Responsibilities
  • Assists with the development and/or review of study-related materials including CRFs, protocols, informed consent forms, monitoring plan, etc.
  • Participates in the identification and recruitment of investigators, assists in the development of subject recruitment strategies and materials.
  • Ensures that any monitoring visits are conducted according to FDA regulations, ICH guidelines, and company standard operating procedures.
  • Evaluates monitoring metrics and provide guidance to align with the monitoring plan.
  • Ensures adequate reporting/tracking of adverse events, protocol deviations and subject status.
  • Performs remote monitoring of the Electronic Data Capture (EDC) system as well as other internal and/or vendor portals, as necessary.
  • Identifies areas requiring follow-up and improvement at each clinical study site and recommends/implements corrective action.
  • Serves as contact for study site personnel to answer questions and resolve study-related issues.
  • 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.
  • Assists with overseeing study vendors to ensure activities are in compliance with contracts.
  • Assists Study PM with invoice processing, as needed.
  • Works collaboratively and effectively in an internal project team and outsourced environment.

Non-Essential Duties & Responsibilities:
  • Attends and participates in internal and external training sessions.
  • Prepares for and conducts site qualification, initiation, interim monitoring, and close-out visits at study sites, including co-monitoring or conducting oversight visits with external CRO monitors.

Supervisory Responsibilities:
  • N/A

Knowledge & Other Qualifications:
  • 2+ years of experience with a Bachelor's degree in a related scientific discipline and/or Registered Nurse Preferred
  • 5+ years of relevant experience with High School Diploma considered.
  • 1+ years of clinical trial experience/monitoring preferred.
  • CRA certification (ACRP or SoCRA for example) a plus.
  • Experience in therapeutic areas of CNS or psychiatry/neurology 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.

Other Characteristics:
  • Willing and able to travel up to 50% on average
  • Willing and able to travel internationally in the future. Ability to obtain a U.S. Passport.
  • Ability to work independently and as part of a team.
  • Able to maintain high ethical standards of integrity and quality.
  • Capable of performing other duties as assigned by management.
  • Capable of being innovative and dynamic in approach to work.
  • Authorized to legally work in the United States without visa sponsorship.

Physical Requirements / Work Environment
  • 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

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.



Rockville, MD
20850 USA



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