Clinical Research Associate II, Field Monitor

Role Summary

Clinical Research Associate II will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support.

Responsibilities

• Develop, review, and update study-related training materials and documents including: site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals
• Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods etc.
• Communicate scientific rationale for assigned studies to team members and clinical sites
• Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements
• Create/edit, distribute and collect site feasibility questionnaires
• Oversee and support collection of essential documents during study start-up
• Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution
• Collect study and site metrics and maintain study trackers, as needed
• Conduct case report form (CRF) data review and review of source documents, work with sites to resolve data queries
• Communicate regularly with field Clinical Research Associates (CRAs) to provide information before and after site visits
• Partner with field CRAs and CTAs to resolve issues identified during site visits
• Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) to properly conduct the trial as well as resolve IP temperature monitoring excursions and train or assist sites with corrective actions
• Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
• Conduct clinical specimen log review, and coordinate shipment of specimens to the sponsor or contracted vendor
• Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted vendors
• Conduct remote monitoring tasks including reconciliation of site investigational product accountability
• Provide data listings and compile clinical study report documents to support medical writing activities
• Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations
• Provide support and escalate issues to the Clinical Trial Manager (CTM) as appropriate
• Performs other duties as assigned

Qualifications

• Bachelor‚Äôs degree in a clinical research, science, or health-related field with 4 years of experience in a clinical research setting; or a high school diploma with 6 years of experience in a clinical research setting required
• Minimum of 2 years‚Äô experience as a Clinical Research Associate I required

Skills

• Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
• Excellent written/oral communication skills
• Strong organizational and multi-tasking skills
• Maintain corporate confidentiality at all times
• Ability to set priorities and independent decision making
• Ability to work independently as well as in teams
• Strong oral and written communication skills
• Outgoing and confident demeanor
• Independent thinker and persuasive communicator
• Detail oriented, with solid organization and time management skills
• Completes projects with reliability and minimal guidance
• Knowledge of drug development process
• Computer literacy: EDC, eTMF, CTMS, etc.
• Working knowledge of ICH E6, and the Code of Federal Regulations

Education

• Bachelor‚Äôs degree in a clinical research, science, or health-related field with 4 years of experience in a clinical research setting; or a high school diploma with 6 years of experience in a clinical research setting required

Additional Requirements

• Must be able to travel up to 75% of the time based on study requirements
• Remote with ability to work flexible hours for various time zones
• Regular work schedule is Monday ‚Äì Friday, within standard business hours; flexibility with manager approval
• Must possess mobility to work in a standard office setting and to use standard office equipment
• Lift and carry materials weighing up to 20 pounds