Senior Clinical Research Associate, Field Monitor

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with clinical research teams to ensure the efficient and effective execution of clinical studies by offering training, interpreting protocols, gathering and reviewing documents, and providing comprehensive trial support.

• Create, review, and update training materials and documents related to studies, such as site initiation training slides, informed consent form templates, procedures manuals, and both laboratory and pharmacy manuals.

• Analyze the medical and scientific objectives of assigned study protocols, procedures, logistics, potential risks to research subjects, safety considerations, and data evaluation methodologies.

• Articulate the scientific rationale for assigned studies to team members and clinical sites.

• Act as the Subject Matter Expert for clinical sites, offering guidance on protocol interpretation and eligibility criteria.

• Oversee and assist in the collection of essential documents during the study initiation phase.

• Gather study and site metrics and maintain study trackers as required.

• Engage in the review of case report forms (CRFs) and source documents, collaborating with sites to address data queries as necessary.

• Maintain regular communication with both field and in-house Clinical Research Associates (CRAs) to relay information before and after site visits.

• Collaborate with field CRAs to address issues identified during site visits.

• Provide training to vendors, investigators, and study coordinators regarding study requirements and offer guidance on site-related issues.

• Execute remote monitoring tasks, including the reconciliation of site investigational product accountability as needed.

• Mentor and train newly hired research personnel.

⛳️ Requirements

• A Bachelor’s degree in clinical research, science, or a health-related field with 6 years of experience in a clinical research environment; or a high school diploma with 8 years of relevant experience.

• At least 2 years of experience as a Clinical Research Associate II or in a higher position is required.

• Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and Adobe.

• Familiarity with job-specific systems and processes as outlined by the company’s Standard Operating Procedures (SOPs) and adherence to the requirements therein.

• Computer literacy in electronic data capture (EDC), electronic trial master file (eTMF), clinical trial management systems (CTMS), etc.

• A solid understanding of ICH E6 guidelines and the Code of Federal Regulations.

🏝️ Benefits

• Options for Medical, Dental, and Vision Plans.

• Health and Financial Wellness Programs.

• Employer Assistance Program (EAP).

• Company-paid and voluntary Life/AD&D, Short-Term, and Long-Term Disability coverage.

• Flexible Spending Accounts for Healthcare and Dependent Care.

• 401(k) Retirement Plan with Company Matching.

• 529 Education Savings Program.

• Voluntary Legal Services, Identity Theft Protection, Pet Insurance, and Employee Discounts, Rewards, and Perks.

• Paid Time Off (PTO) includes 11 Holidays.

• Exempt Employees qualify for Unlimited PTO.

• Non-Exempt Employees are entitled to 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days, and 1 Cultural Day.