CRA II - Sponsor Dedicated - Neurology / Oncology (Home-Based in Puerto Rico)
Remote · United States
Job Summary
CRA II - Sponsor Dedicated role focused on Neurology/Oncology with home-based work in Puerto Rico. Responsibilities include site qualification/initiation, interim monitoring, site management and close-out visits (on-site or remote); assess site performance, ensure regulatory/GCP/GPP compliance, verify informed consent, protect subject data confidentiality, conduct source document reviews, ensure accurate CRF data entry, apply query resolution, support IP inventory and ISF/TMF processes, and prepare for sponsor meetings. Will remotely or onsite support recruitment/retention strategies, manage tracking and timelines, and train site staff as needed; travel up to 75% is expected. Requires a bachelor’s degree or RN and knowledge of GCP/ICH guidelines, strong communication skills, and adaptability to changing priorities. US-based remote work options and potential involvement in Real World Late Phase activities (SMA II) are noted. Benefits overview and pipeline opportunities are described in the posting.
Required 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
- 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
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