Sr Clinical Research Associate - Sponsor Dedicated - Cardiovascular; Home-Based in Houston,TX

Sr Clinical Research Associate - Sponsor Dedicated - Cardiovascular (Home-Based in Houston,TX)

Updated: March 4, 2026
Location: Morrisville, NC, United States
Job :

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes, simplifying and streamlining our work so that we are easier to work with and easier to work for.

• Perform site qualification, site initiation, interim monitoring, site management and close‑out visits (performed on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Use judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site‑specific actions; immediately communicate/escalate serious issues to the project team and develop action plans. Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrate 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): assess site processes; conduct Source Document Review of appropriate site source documents and medical records; verify required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records; apply query resolution techniques remotely and on site; provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines;
  
  utilize available hardware and software to support the effective conduct of the clinical study data review and capture; verify site compliance with electronic data capture requirements.
• May perform investigational product (IP) inventory, reconciliation and reviews of storage and security; verify the IP has been dispensed and administered to subjects/patients according to the protocol; verify issues or risks associated with blinded or randomized information related to IP; apply knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re) labelled, imported and released/returned.
• Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness; reconcile contents of the ISF with the Trial Master File (TMF); ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Document 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; support subject/patient recruitment, retention and awareness strategies; enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Understand project scope, budgets, and timelines for own and others’ activities; manage site‑level activities/communication to ensure project objectives, deliverables and timelines are met; adapt quickly to changing priorities to achieve goals/targets.
• Act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate; ensure all assigned sites and project‑specific site team members are trained and compliant with applicable requirements.
• Prepare for and attend Investigator Meetings and/or sponsor face‑to‑face meetings; participate, and with supervision, lead global clinical monitoring/project staff meetings (including Sponsor representation, as applicable) and attend clinical training sessions according to the project specific requirements.
• Provide guidance at the site and project level…