Clinical Research Associate

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

📋 Description

• Perform site monitoring tasks for clinical trials.

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

• Ensure adherence to protocols and maintain quality standards.

• Collaborate with Lead CRAs, Senior CRAs, in-house CRAs, the Associate Director of Clinical Monitoring, and Project Managers.

• Provide guidance, oversight, and feedback to the CRA team regarding project scope, standard operating procedures (SOPs), timelines, and budgets.

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

• Ensure timely and appropriate investigator site visits.

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

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

• Set up and gather site-specific ethics documents and support site contract negotiations.

• Supply monthly billing details to the finance team.

• Manage study budgets and serve as the sponsor contact for standalone projects.

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

• Prepare precise and timely monitoring visit reports.

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

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

• Manage accountability of investigational products.

• Review regulatory binders for the site.

• Maintain communication with study sites, evaluate patient accrual, and respond to sponsor inquiries.

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

• Facilitate adverse event reporting and reconcile Serious Adverse Event (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.

• Assist in onboarding, training, and mentoring of CRAs.

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

• Manage competing priorities and undertake additional assigned responsibilities.

⛳️ Requirements

• Minimum of 2 years of monitoring experience is required.

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

• Capability to independently manage monitoring activities.

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

• Strong organizational abilities with the capacity to multitask in a fast-paced environment.

• Competence in managing priorities, organizing time, and resolving issues.

• Excellent analytical, negotiation, meeting management, cross-functional teamwork, and leadership abilities.

• Willingness to travel.

• Ability to handle stress effectively.

• Professional, reliable, and disciplined.

• Aptitude for solving unstructured or ambiguous challenges.

• Strong command of the local language, both written and spoken, in the country where monitoring is conducted.

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

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

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

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

• Familiarity with regulatory and ethical requirements.

• Proficiency in the English language.

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

🏝️ Benefits

• Options for remote and onsite work for monitoring visits.

• Regular employment contract.

• Global, collaborative work environment.

• Opportunities for CRA mentoring and training.

• Professional development through participation in internal, client/sponsor, scientific, and other meetings.