Clinical Research Associate

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

📋 Description

• Execute site monitoring duties for clinical trials.

• Offer oversight, leadership, and direction in the management and execution of clinical trials to guarantee compliance and quality.

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

• Review monitoring visit reports and perform co-monitoring and evaluation visits as required.

• Ensure timely and appropriate investigator site visits.

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

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

• Assist in the collection of ethics documents and site contract negotiations.

• Supply monthly billing details to the finance department.

• Manage study budgets and act as the sponsor liaison for stand-alone projects.

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

• Prepare precise and timely monitoring visit reports.

• Review and verify source documents and CRF data.

• Perform quality control and validation of eTMF/TMF documents.

• Conduct accountability checks for investigational products.

• Review site regulatory binders.

• Maintain communication with study sites regarding protocol/GCP compliance, patient enrollment, and sponsor requests.

• Ensure adherence to ICH GCP, FDA regulations, and company/sponsor SOPs.

• Engage in internal, client/sponsor, scientific, and other related meetings.

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

• Collaborate with in-house CRAs/CTC and data management to resolve data discrepancies.

• Identify site issues and formulate problem-solving strategies.

• Prepare for audits at study sites as necessary.

• Work together with other CRAs to ensure consistency and teamwork.

• Assist in the training and onboarding of new CRAs.

• Mentor CRAs.

• Collaborate on the development and maintenance of the Clinical Trial Management System (CTMS).

• Manage conflicting priorities and meet commitments.

• Undertake additional assigned responsibilities.

⛳️ Requirements

• EU: Graduation in a scientific health-related field.

• EU (Italy): Certified Monitor in accordance with the Italian CRO decree dated 15Nov2011.

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

• Capable of independently managing monitoring activities.

• Quality-focused; demonstrated ability to be meticulous, thorough, and detail-oriented.

• Strong organizational abilities and competency in multitasking and working efficiently in a fast-paced environment.

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

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

• Willingness to travel.

• Ability to handle stress effectively.

• Professional, reliable, and disciplined.

• Proficient in tackling unstructured or ambiguous challenges.

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

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

• Good computer proficiency, capable of using clinical trial management systems, clinical trial databases, and electronic data capture.

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

• Knowledgeable in clinical research, ICH GCP, and local regulations.

• Familiar with Regulatory and Ethical requirements.

• EU: Adequate proficiency in English.

• Bachelor of Science (BS) in Biology or Life Sciences.

🏝️ Benefits

• Remote work arrangement.

• Part-time employment.

• Contingency Workforce contract type.