Senior Clinical Research Associate, Field Monitor

Role Summary

Senior Clinical Research Associate participates in clinical research teams to support efficient and compliant conduct of clinical studies, providing training, protocol interpretation, document collection and review, and overall 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
• 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.

Qualifications

• 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

Skills

• Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
• Excellent written/oral communication skills as well as 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
• 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’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

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