Experienced Clinical Research Associate - Sponsor Dedicated

Syneos Health, Inc.; Virginia (MN); Hybrid; USD 70,000 - 110,000; Full time

Job summary

Syneos Health, Inc. is seeking an Experienced Clinical Research Associate - Sponsor Dedicated to support monitoring activities remotely in the US. The role involves site qualification, initiation, interim monitoring, and close-out visits with emphasis on regulatory compliance and data integrity.

You will verify informed consent, manage ISF/TMF reconciliation, and assist with site staff training and issue resolution, ensuring alignment with ICH-GCP and SOPs across trials.

Qualifications

• Experience in clinical monitoring and site management.
• Familiarity with ICH-GCP guidelines and SOPs.
• Ability to work remotely with on-site visits as needed.

Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or GPP and protocol compliance. Uses judgment to evaluate site performance and escalate issues to the project team; maintains knowledge of guidelines and regulations.
• Verifies informed consent processes and protects subject confidentiality; assesses safety and data integrity at investigator sites.
• Per the CMP/SMP: Assesses site processes; conducts Source Document Review of site source documents and medical records. Verifies CRF data accuracy and completeness; drives issue resolution within timelines.
• May perform IP inventory, reconciliation and reviews storage and security; ensures IP labeling, import/export per protocol and regulatory requirements.
• Routinely reviews ISF for accuracy, timeliness and completeness; reconciles ISF with TMF and ensures archiving per guidelines.
• Documents activities via letters, logs, trip reports, and other required documents; supports recruitment, retention and tracking of observations.
• For assigned activities, understands scope, budgets and timelines; manages site-level communications to meet goals.
• Acts as liaison with study site personnel and ensures training/compliance of site team members.
• Prepares for and attends Investigator Meetings and sponsor interactions.

Skills

Site qualification

Site initiation

Interim monitoring

Data integrity

ICH-GCP

Source Document Review

ISF/TMF reconciliation

Job description

Experienced Clinical Research Associate - Sponsor Dedicated

Updated: Yesterday
Location: Remote, VA, United States
Job ID:25109784-OTHLOC-1500-2DVA-2DR

Description

Experienced Clinical Research Associate - Sponsor Dedicated

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
• Prepares for and attends Investigator Meetings and/or sponsor