Description
Syneos Health is seeking a well-qualified CRA II or a Senior CRA with a strong background in oncology clinical trials across all phases of development.
Job Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits to ensure regulatory, ICH-GCP and protocol compliance.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
- Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.
- Conducts Source Document Review of 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, 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.
- 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.
- A well-qualified CRA II or a Senior CRA with a strong background in oncology clinical trials.
- Experience with early phase/first-in-human studies, safety, PK/PD, and dose-escalation designs.
- Hands-on experience supporting solid tumor indications such as melanoma, breast, ovarian, prostate, and lung cancer.
- Fluency in both English and German.
- Must demonstrate good computer skills and be able to embrace new technologies.
- Excellent communication, presentation and interpersonal skills.
- Ability to manage required travel of up to 75% on a regular basis.
Benefits
Syneos Health offers a comprehensive benefits package, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.