Senior Oncology CRA – Remote, Travel, Impactful Trials

TD2 International; Scottsdale (AZ); À distance; USD 95 000 - 140 000; Plein temps

Avantages offerts par ce poste

Remote work

Travel up to 50%

Résumé du poste

TD2, a leading oncology-focused CRO, seeks an experienced Clinical Research Associate to independently manage trial sites and ensure compliance with protocol, GCP, ICH, and FDA requirements across Phase I-III oncology studies. The role requires strong collaboration with investigators, start-up through close-out activities, and meticulous monitoring practices.

Candidates should have at least five years as a CRA, deep oncology monitoring experience, and be comfortable with up to 50% overnight

Qualifications

• Five years of CRA experience in a CRO or sponsor.
• Five years of experience monitoring Phase I oncology trials.
• Four years of experience in oncology therapeutics.
• Strong knowledge of GCP, ICH, and FDA regulatory requirements.

Responsabilités

• Monitor Phase I-III oncology trials to protect subjects and ensure protocol compliance.
• Oversee site start-up through close-out activities.
• Coordinate site qualification, initiation, interim monitoring, and close-out visits.
• Develop study-specific Monitoring Plans for assigned studies.
• Build relationships with investigators and site staff to resolve issues and ensure oversight.
• Write Monitoring Visit Reports and follow-up letters within the allotted timeframe.

Connaissances

GCP knowledge

ICH guidelines

FDA regulations

Presentation skills

Outils

Microsoft Office

Site EMR

EDC

CTMS

Description du poste

TD2, a leading oncology-focused CRO, seeks an experienced Clinical Research Associate to independently manage trial sites and ensure compliance with protocol, GCP, ICH, and FDA requirements across Phase I-III oncology studies. The role requires strong collaboration with investigators, start-up through close-out activities, and meticulous monitoring practices.

Candidates should have at least five years as a CRA, deep oncology monitoring experience, and be comfortable with up to 50% overnight