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.

• Ensure compliance with protocols, maintain quality standards, and adhere to SOPs, timelines, and budgets.

• Review monitoring visit reports and engage in co-monitoring and evaluation visits.

• Guarantee timely visits to investigator sites.

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

• Assist in the development of Monitoring Plans, training presentations, ethics documents, and site contract negotiations.

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

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

• Verify source documents and ensure integrity of CRF data.

• Carry out quality control and document verification for eTMF/TMF.

• Manage investigational product accountability and review regulatory binders.

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

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

• Resolve discrepancies in data queries with in-house CRAs/CTC and data management.

• Identify site-related challenges and devise problem-solving strategies.

• Prepare study sites for audits.

• Mentor CRAs and support the onboarding and training of new CRAs.

• Collaborate on the development and maintenance of CTMS.

• Manage conflicting priorities and undertake additional assigned responsibilities.

⛳️ Requirements

• Minimum of 2 years of monitoring experience is required.

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

• Ability to independently manage monitoring activities.

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

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

• Competence in managing priorities, organizing time, and addressing problems.

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

• Willingness to travel.

• Ability to handle stress effectively.

• Professional, reliable, and disciplined demeanor.

• Capacity to tackle unstructured or ambiguous challenges creatively.

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

• Excellent communication and interpersonal abilities with a customer service focus.

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

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

• Understanding of regulatory and ethical requirements.

• Proficiency in English.

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

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• Supportive and collaborative work environment.

• Flexible work arrangements.

• Employee wellness programs.