Clinical Research Associate

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

📋 Description

• Independently carry out site monitoring duties for clinical trials.

• Provide leadership, oversight, and direction in the management and execution of clinical trials.

• Ensure adherence to protocols and maintain high quality standards.

• Collaborate with Lead CRAs, Senior CRAs, in-house CRAs, clinical monitoring leadership, and Project Managers.

• Address inquiries from sites and support study recruitment, training, and site-related challenges.

• Offer guidance, oversight, and feedback to the CRA team regarding project scope, SOPs, timelines, and budgets.

• Review monitoring visit reports and conduct co-monitoring and evaluation visits as necessary.

• Ensure that investigator site visits are conducted appropriately and in a timely manner.

• Coordinate with cross-functional departments to resolve issues related to clinical trial monitoring.

• Assist in the development of study-specific Monitoring Plans and training presentations.

• Support ethics documentation and negotiation of site contracts.

• Provide monthly billing details to the finance team.

• Manage study budgets and act as a sponsor representative for stand-alone monitoring projects.

• Conduct qualification, initiation, interim, and close-out visits both remotely and onsite.

• Prepare precise and timely monitoring visit reports.

• Review source documents and verify the integrity of CRF data.

• Perform quality control and document verification for eTMF/TMF.

• Conduct accountability checks for investigational products.

• Review site regulatory binders for compliance.

• Maintain regular communication with study sites and monitor patient accrual.

• Ensure compliance with ICH GCP, FDA regulations, and company/sponsor SOPs.

• Participate in internal, client/sponsor, scientific, and other relevant meetings.

• Facilitate the reporting of adverse events and reconcile SAE reports with source documentation and CRFs.

• Address data discrepancies in collaboration with in-house CRAs/CTC and data management.

• Identify site-related issues and create effective problem-solving strategies.

• Prepare for audits at study sites.

• Work with other CRAs to promote consistency and teamwork.

• Assist with the training and onboarding of new CRAs.

• Mentor junior CRAs.

• Collaborate on the development and maintenance of CTMS.

• Manage conflicting priorities while meeting commitments.

• Perform additional tasks as assigned.

⛳️ Requirements

• Ability to build and sustain positive relationships with Sponsors, Site members, and Project Team members.

• Capacity to autonomously manage monitoring activities.

• Quality-focused; meticulous, thorough, and detail-oriented.

• Strong organizational skills with the ability to multitask in a dynamic environment.

• Proficient in managing priorities, organizing time effectively, and solving problems.

• Strong analytical, negotiation, meeting management, cross-functional team, and leadership capabilities.

• Willingness to travel as required.

• Ability to handle stress effectively.

• Professional, reliable, and disciplined work ethic.

• Capability to address unstructured or ambiguous challenges with problem-solving skills.

• Strong command of the local language, both written and verbal, in the country where monitoring activities are conducted.

• Excellent communication and interpersonal skills with a focus on customer service.

• Proficient in computer skills, including clinical trial management systems, clinical trial databases, and electronic data capture.

• Self-motivated individual who excels in a collaborative, less structured team environment.

• Familiarity with clinical research, ICH GCP, and local regulations.

• Understanding of regulatory and ethical requirements.

• Adequate proficiency in English for EU roles.

• Bachelor of Science degree in Biology or Life Sciences.

🏝️ Benefits

• Remote work arrangement.

• Opportunities for collaboration with global teams across various time zones.