Clinical Research Associate

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

📋 Description

• Execute 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 quality standards.

• Review monitoring visit reports and carry out co-monitoring and evaluation visits.

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

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

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

• Gather ethics documents and aid in site contract negotiations.

• Supply monthly billing information to the finance department.

• Oversee study budgets and serve as the sponsor referent for standalone projects.

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

• Prepare monitoring visit reports that document site issues, resolutions, protocol deviations, study progress, and enrollment status.

• Review and validate source documents and CRF data.

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

• Manage investigational product accountability.

• Review regulatory binders for sites.

• Maintain contact with sites for protocol/GCP compliance and 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 with in-house CRAs/CTC and data management.

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

• Prepare for audits at study sites.

• Collaborate with other CRAs.

• Assist in the training and onboarding of CRAs.

• Provide mentorship to CRAs.

• Collaborate on the development and maintenance of CTMS.

• Manage conflicting priorities while fulfilling commitments.

• Carry out additional assigned responsibilities.

⛳️ Requirements

• Capability to establish and maintain positive relationships with Sponsors, Site, and Project Team members.

• Ability to independently manage monitoring activities.

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

• Strong organizational skills and capacity to multitask in a dynamic environment.

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

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

• Willingness to travel.

• Ability to handle stress effectively.

• Professional, trustworthy, and disciplined demeanor.

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

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

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

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

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

• Understanding of regulatory and ethical requirements.

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

• Proficiency in the English language.

🏝️ Benefits

• Opportunity for remote work.

• Regular employment contract.