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Senior Clinical Research Associate, Field Monitor
1 month ago
Position Summary
Senior Clinical Research Associate 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.
Essential Functions
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
Collect study and site metrics and maintain study trackers, as needed
Participate in case report form (CRF) data review and review of source documents, work with sites to resolve data queries as needed
Communicate regularly with field and in-house Clinical Research Associates (CRAs) to provide information before and after site visits
Partner with field CRAs 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
Clinical specimen log review, coordinating shipment of specimens to the sponsor or contracted vendor
Conduct remote monitoring tasks including reconciliation of site investigational product accountability, as needed
Provide mentorship and training to newly hired research staff.
Performs other duties as assigned.
Education & Experience
Bachelor's degree in a clinical research, science, or health-related field with 6 years of experience in a clinical research setting; or a high school diploma with 8 years of experience in a clinical research setting
Minimum of 2 years' experience as a Clinical Research Associate II or higher required
Knowledge, Skills, & Abilities
Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
Excellent written/oral communication skills as well as strong organizational and multi-tasking skills
Strong organizational and multi-tasking skills
Understand the job-specific system, processes as defined by the company's SOPs, and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager.
Maintain corporate confidentiality at all times
Ability to set priorities and independent decision making
Ability to work independently as well as in teams
Ability to discover issues, provides solutions and provides guidance to in-house team on how to address issues
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
Working Environment / Physical Environment
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
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