Experienced Clinical Research Associate

Experienced Clinical Research Associate - Sponsor Dedicated

Overview

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:

• 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. 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 compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site‑specific actions; immediately communicates or escalates serious issues to the project team and develops action plans.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting confidentiality of each subject/patient and assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation or violations and pharmacovigilance issues.
• Per the Clinical Monitoring/Site Management Plan, 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 is accurate and complete, and applies query resolution techniques remotely and on‑site to drive query resolution to closure within agreed timelines.
• May perform investigational product (IP) inventory, reconciliation, reviews storage and security, verifies the IP has been dispensed and administered to subjects/patients according to the protocol, and verifies issues or risks associated with blinded or randomized information related to IP.
• Routinely reviews the Investigator Site File for accuracy, timeliness and completeness, reconciles contents of the ISF with the Trial Master File, and 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. Supports subject/patient recruitment, retention and awareness strategies, and enters data into tracking systems as required.
• For assigned activities, understands project scope, budgets and timelines; manages site‑level activities and communication to ensure project objectives, deliverables and timelines are met and can quickly adapt to changing priorities.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate, and 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 face‑to‑face meetings, participates in global clinical monitoring/project staff meetings, and attends clinical training sessions according to project specific requirements.
• Provides guidance at the site and project level toward audit readiness standards and supports preparation for audit and required follow‑up actions.
• Maintains a working knowledge of ICH‑GCP Guidelines and other applicable guidance, relevant regulations and company SOPs/p