CRA II - Sponsor Dedicated - Neurology / Oncology (Home-Based in Puerto Rico)

Syneos Health, Inc.

Job Overview

Location

USA-PR-Remote

Job Type

Full-time

Full Job Description

📋 Description

• Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) to ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol requirements.
• Verify proper documentation and execution of informed consent for all study subjects, ensuring patient confidentiality and data integrity are maintained at all times.
• Conduct source document reviews and verify accuracy and completeness of clinical data entered into case report forms (CRFs), applying query resolution techniques both remotely and on-site.
• Monitor and reconcile investigational product (IP) inventory, storage, security, dispensing, and administration per protocol and regulatory standards, including proper labeling, import, and return procedures.
• Routinely audit and maintain the Investigator Site File (ISF) for accuracy, timeliness, and completeness, ensuring alignment with the Trial Master File (TMF) and local archiving regulations.
• Document all monitoring activities through confirmation letters, trip reports, follow-up letters, and communication logs in accordance with company SOPs and Clinical Monitoring/Site Management Plans.
• Support subject recruitment and retention strategies, entering data into tracking systems to monitor site performance, observations, and action items to resolution.
• Act as primary liaison between Syneos Health and study site personnel, ensuring site staff are trained and compliant with regulatory and protocol requirements.
• Prepare for and participate in Investigator Meetings, sponsor meetings, and global clinical monitoring/project team meetings, including representation from Sponsor stakeholders.
• Ensure sites are audit-ready by providing guidance on compliance standards and supporting preparation for regulatory audits and follow-up actions.
• Perform chart abstraction and data collection activities for Real World Late Phase studies, collaborating with Sponsor affiliates, medical science liaisons, and local country staff.
• Identify and recommend potential study sites based on local knowledge of treatment patterns, patient advocacy groups, and Health Care Provider (HCP) associations.
• Train junior staff members as needed and proactively communicate out-of-scope activities to Lead CRA or Project Manager.
• Maintain current knowledge of ICH/GCP guidelines, applicable regulations, and company SOPs, completing all required training promptly.
• Manage up to 75% travel as required for on-site monitoring activities across Puerto Rico and potentially other U.S. locations.
• Utilize electronic data capture systems and other clinical trial technologies to support efficient data review, capture, and site communication.
• Ensure compliance with all site-specific access requirements, including providing medical and personal information necessary for facility entry as mandated by study sites.

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice (GCP) and ICH Guidelines and other applicable regulatory requirements
• Demonstrated ability to manage up to 75% travel on a regular basis
• Proficient computer skills and ability to adopt new clinical trial technologies
• Excellent communication, presentation, and interpersonal skills
• U.S. residency required (job is home-based in Puerto Rico)

🏖️ Benefits

• Company car or car allowance
• Health benefits including Medical, Dental, and Vision coverage
• Company match 401(k)
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions or bonuses based on company and individual performance
• Flexible paid time off (PTO) and sick time

Skills & Technologies

GCP

Remote

Degree Required

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Syneos Health, Inc.

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About Syneos Health, Inc.

Syneos Health is a global biopharmaceutical services organization providing clinical and commercial solutions. It integrates clinical development, outsourced commercialization, consulting, and communications services to accelerate the delivery of therapies to market. The company supports pharmaceutical, biotechnology, and medical device clients across all phases of product development and commercialization, operating in North America, Europe, and Asia-Pacific.

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