Clinical Research Associate II

About the role

We are a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. Our Clinical Development model brings the customer and the patient to the center of everything we do. As an Experienced Clinical Research Associate (CRA), you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals in a Functional Service Provider or Full-Service environment.

We are agile and driven to accelerate the delivery of therapies, because we are passionate about changing lives. Our 29,000 employees across 110 countries know: work here matters everywhere.

We are committed to our Total Self culture—where you can authentically be yourself—and continuously build the company we all want to work for. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong.

Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits (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; provides 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 subject/patient confidentiality.
• 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, providing guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
  • Utilizes available hardware and software to support 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 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 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.
• Adapts quickly 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 face-to-face meetings; participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) 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 or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
• For Real World Late Phase, uses the business card title of Site Management Associate II. Additional responsibilities include:
  • Site support throughout the study lifecycle from site identification through close-out.
  • Knowledge of local requirements for real-world late-phase study designs.
  • Chart abstraction activities and data collection.
  • Collaboration with Sponsor affiliates, medical science liaisons, and local country staff.
  • May train junior staff.
  • Identifies and communicates out-of-scope activities to Lead CRA/Project Manager.
  • Proactively suggests potential sites based on local knowledge of treatment patterns, patient advocacy, and Health Care Provider (HCP) associations.

Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Good computer skills and ability to embrace new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.

US ONLY: As part of your employment, you may be deployed to sites that require certain medical and other personal information to gain facility access. You are required to comply with site requests for additional information as a condition of employment. Failure to provide requested information may result in a site barring you from entry, which could put your ongoing employment at risk.

Benefits

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 a total rewards program.