[Hiring] Senior CRA - Phase I oncology trials @Syneos Health

Role Description

For one of our clients, a biopharmaceutical company, we are currently looking for a senior CRA. This role requires demonstrated proficiency in traditional on-site monitoring models, including full source data verification, investigational product accountability, and strict adherence to ICH/GCP and regulatory requirements.

• 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; 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.
• 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.
• 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 via review of site source documents and medical records.
• 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 (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 as required to track all observations, ongoing status and assigned action items to resolution.
• Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities/communication to ensure project objectives, deliverables and timelines are met.
• May act as primary liaison with project 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, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• May provide training or mentorship to more junior level CRAs.
• May perform training and sign off visits for junior CRA staff, as assigned.

Qualifications

• 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.
• Experience as CRA with a strong background in oncology clinical trials across all phases of development, including early phase/first-in-human studies, safety, PK/PD, and dose-escalation designs.
• Must demonstrate good computer skills and be able to embrace new technologies.
• The ideal candidate will have hands-on experience supporting solid tumor indications such as melanoma, breast, ovarian, prostate, and lung cancer.
• Comfortable operating in fast-paced development environments where quality execution supports accelerated timelines and regulatory submissions.
• Prior exposure to investigational products involving Toll-Like Receptor (TLR) pathways, PARP1 inhibitors, or Werner helicase protein is desirable but not required.
• Excellent communication, presentation and interpersonal skills.
• Basic level of critical thinking skills expected.
• Multilingual capabilities, particularly fluency in English with French, German, and/or Flemish, are strongly preferred.
• Ability to manage required travel of up to 75% on a regular basis.

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 total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.
• Driven to Deliver – captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• Continuously building the company we all want to work for and our customers want to work with.
• Bringing together smart colleagues from across the world to shape the future of healthcare, driving impact for customers and defining the pace of patient progress.