[Hiring] Senior Clinical Research Associate I Oncology Phase I @Syneos Health

Role Description

The Sr CRA I Oncology Phase I is responsible for the following:

• Performs 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.
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; 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.
• 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.
• Assesses site processes per the Clinical Monitoring/Site Management Plan (CMP/SMP).
• 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.
• 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.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
• Supports subject/patient recruitment, retention, and awareness strategies.
• Understands project scope, budgets, and timelines for own and others’ activities in the clinical team.
• May act as primary liaison with project site personnel or in collaboration with Central Monitoring Associate.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.
• Provides guidance at the site and project level towards audit readiness standards.
• May provide training or mentorship to more junior level CRAs.
• May be mentored and assigned clinical operations lead tasks under supervision.
• Additional responsibilities include site support throughout the study lifecycle from site identification through close out.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and strong experience in oncology clinical trials.
• High English level.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Basic level of critical thinking skills expected.
• Ability to manage required travel of up to 75% on a regular basis.

Requirements

• Knowledge of local requirements for real world late phase study designs.
• Chart abstraction activities and data collection.
• Collaborate and build relationships with Sponsor and other affiliates, medical science liaisons, and local country staff.
• Identify and communicate out of scope activities to Lead CRA/Project Manager.
• Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy, and Health Care Provider (HCP) associations.
• Identify operational efficiencies and process improvements.
• Develop country level informed consent forms.
• Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared.
• Participate in bid defense meetings.

Benefits

• 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.
• Commitment to building an inclusive culture.