Clinical Research Associate

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

📋 Description

• Independently carry out site monitoring responsibilities for clinical trials.

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

• Ensure compliance with protocols, maintain quality, and adhere to SOPs, timelines, and budgetary constraints.

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

• Ensure timely visits to investigator sites.

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

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

• Help with the collection of ethics documents and the negotiation of site contracts.

• Provide monthly billing information to the finance department.

• Manage study budgets and serve as the sponsor referent for independent projects.

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

• Prepare detailed monitoring visit reports documenting site issues, resolutions, protocol deviations, study progress, and enrollment metrics.

• Review source documents to ensure the integrity of CRF data.

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

• Conduct accountability for investigational products.

• Review regulatory binders at study sites.

• Maintain communication with study sites to ensure compliance with protocols/GCP and to evaluate patient accrual.

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

• Participate in internal, client/sponsor, scientific, and other 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 discrepancies in data queries.

• Identify site-related issues and formulate problem-solving strategies.

• Conduct audit preparations at study sites as necessary.

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

• Assist in the training and onboarding of new CRAs.

• Provide mentorship to CRAs.

• Collaborate on the development and maintenance of the CTMS.

• Manage competing priorities and fulfill commitments.

• Undertake additional assigned duties as required.

⛳️ Requirements

• EU: Degree 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.

• Capability to autonomously oversee monitoring activities.

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

• Strong organizational skills with the ability to multitask in a fast-paced environment.

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

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

• Willingness to travel.

• Capacity to manage stress effectively.

• Professional, trustworthy, and disciplined demeanor.

• Ability 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 customer service orientation.

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

• Self-motivated individual capable of thriving in a collaborative, less structured team environment.

• Knowledge of clinical research, ICH GCP, and local regulations.

• Familiarity with regulatory and ethical requirements.

• EU: Proficient in English.

• Bachelor of Science in Biology or Life Sciences.

🏝️ Benefits

• Opportunity for remote work.

• Regular employment contract.