Description
Syneos Health is seeking a senior CRA for one of its clients, a biopharmaceutical company. The successful candidate will have 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.
Job Responsibilities
- 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.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
- Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.
- 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.
- May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
- 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 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.
- 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 and supports preparation for audit and required follow-up actions.
- May provide training or mentorship to more junior level CRAs.
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
- 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.
- Phase I oncology experience is essential for this role
- Excellent communication, presentation and interpersonal skills.
- Multilingual capabilities, English and German
- Ability to manage required travel of up to 75% on a regular basis