Remote CRA II: Oncology & Ophthalmology Trials

Syneos Health/ inVentiv Health Commercial LLC; Iowa (LA); On-site; USD 80,000 - 105,000; Full time

Job summary

Syneos Health is seeking a CRA II for Oncology/Ophthalmology (home-based, Midwest region). You will perform site qualification, initiate visits, monitoring and close-out activities while ensuring regulatory and GCP compliance.

Responsibilities include source data verification, IP inventory oversight, ISF review, and site-team communications. Travel up to 75% is required as part of role. Bachelor's degree or RN and strong communication skills are essential.

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.

Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities 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.
• Per the CMP/SMP: Assesses site processes. Conducts Source Document Review of site documents and medical records. Verifies data in the CRF is accurate and complete.
• May perform IP inventory, reconciliation and reviews storage and security per protocol.
• Routinely reviews the ISF for accuracy and ensures archiving of essential documents.
• Documents activities and supports recruitment, retention and tracking in systems.

Skills

GCP knowledge

Communication skills

Computer skills

Willing to travel

US employment policy awareness

Education

Bachelor's degree or RN

Job description

Syneos Health is seeking a CRA II for Oncology/Ophthalmology (home-based, Midwest region). You will perform site qualification, initiate visits, monitoring and close-out activities while ensuring regulatory and GCP compliance.

Responsibilities include source data verification, IP inventory oversight, ISF review, and site-team communications. Travel up to 75% is required as part of role. Bachelor's degree or RN and strong communication skills are essential.