Senior Clinical Research Associate
- Posted: over a month ago
To support clinical trial activity and act as a point of contact for assigned studies. To create and/or lead internal documentation/communication, to ensure compliance with the clinical trial protocol, to check clinical site activities, to review Case Report Forms (CRFs) and to manage clinical research sites and vendors.
Essential Duties & Responsibilities
- Contributes with the development and/or review of study-related materials including CRFs, protocols, informed consent forms, study plans, status reports, etc.
- Participates in the identification and recruitment of investigators and assists in the development of subject recruitment strategies and materials.
- Serves as a point of contact for study site personnel to answer questions and resolve any study-related issues.
- Coordinates work with CRAs monitoring on site and junior level In-House CRAs
- Manages select study vendors ensuring compliance to the statement of work and protocol.
- Mentors and trains junior level Clinical Research Associates.
- Provides study-specific trainings.
- 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 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/implement corrective action.
- Confirms that data recorded on CRFs are accurate and complete while overseeing monitoring metrics.
- Track study supplies and coordinate shipments of supplies to sites as needed.
- Collect, track, and review all site regulatory documents.
- Oversees collection of regulatory documents including requirements 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.
- Maintains project tracking tools.
- Interacts with sites, clients, vendors and internal study team members.
- Assists the CPM in creating and overseeing the trial budget.
- Prepares agenda and meeting minutes. Attends project team meetings, provide updates on project status and site-specific performance.
Non-Essential Duties & Responsibilities:
- Attends and participates in internal and external training sessions.
- Performs on-site co-monitoring and remote monitoring activities.
- Prepares for and conducts site qualification, initiation, interim monitoring, and close-out visits at study sites, including co-monitoring external CRO monitors.
- Participates in the preparation for investigator meetings; presents or assists in presentation.
- 4+ years of related experience with a BA/BS degree, preferably in a life science, nursing, pharmacy or related field.
- 3+ years of direct work experience managing essential documents within the CRO, pharmaceutical, or biotechnology industry.
- CCRA or CCRP certification (ACRP or SOCRA for example) a plus.
- Experience in therapeutic areas of CNS or psychiatry/neurology a plus.
- Working knowledge of ICHE6, and the Code of Federal Regulations.
- Strong organizational skills and multi-tasking skills.
- Attention to detail, strong written and verbal communication skills.
- Excellent computer proficiency of Microsoft Office package including Word, Outlook, and Excel.
- Willing and able to travel up to 25% on average,
- Willing and able to travel internationally in the future. Ability to obtain a U.S. Passport.
- Able to maintain high ethical standards of integrity and quality.
- Ability to work independently and as part of a team.
- 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.
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.
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