Experienced Clinical Research Associate - Sponsor Dedicated

Syneos Health, Inc.; North Carolina; Hybrid; USD 85,000 - 120,000; Full time

Job summary

Syneos Health is seeking an Experienced Clinical Research Associate for sponsor-dedicated work. The role operates remotely within the United States and supports site qualification, initiation, monitoring, and close-out activities in accordance with ICH-GCP and study protocol.

You will verify informed consent, protect patient confidentiality, and assess safety and data integrity. The job involves CMP/SMP adherence, source document review, CRF data checks, and IP inventory management to ensure

Qualifications

• Experience with clinical monitoring and site management activities.
• Familiarity with ICH-GCP guidelines and regulatory requirements.
• Ability to review source documents and ensure data accuracy.

Responsibilities

• Performs site qualification, initiation, interim monitoring, management and close-out visits (on-site or remote) with regulatory and protocol compliance.
• Verifies informed consent processes and protects subject confidentiality; assesses safety and data integrity implications.
• Conducts CMP/SMP-based assessments, source document review, CRF data accuracy checks, and supports query resolution remotely and on-site.
• Manages IP inventory, labeling, storage, and reconciliation per protocol requirements.
• Routinely reviews ISF accuracy and reconciles with Trial Master File.

Skills

ICH-GCP knowledge

Regulatory compliance

Site management

Data review

Source Document Review

IP inventory

Job description

Experienced Clinical Research Associate - Sponsor Dedicated

Updated: Yesterday
Location: Remote, NC, United States
Job ID:25109784

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. Assess 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