Clinical Research Associate.

Katalyst Healthcares & Life Sciences • Woodcliff Lake, NJ, United States • $200k - $250k / year • 1w ago

Job Description

Requirements:

Assist in the management of the day-to-day operations of clinical trials including coordination and oversight of all CRO/clinical site/vendor activities, liaison between Clinical Operations Manager and CRO, manage scopes of work/budgets/invoice payments.
Assist in the management of the Trial Master File (submit documents, reconciliation, QC, etc.).
Participate in development of protocol, case report form, CRF guidelines and other study documents. Prepare and/or review regulatory documents (e.g. ICF), contracts, requests for proposal. Ensure the training of CROs/investigators on protocol, regulatory, Eisai SOPs and data issues.
Reviews and approves monitoring reports and ensures tracking of ongoing site issues.

Responsibilities:

Onsite monitoring may also be required.
Minimum of college degree in a relevant discipline.
Bachelor's degree in relevant scientific discipline preferred.
Oncology experience highly preferred.
MUST have experience with data review and patient profile review.

Strongly Preferred:

3-5 years in-house in pharma company. Not just 3-5 years in CRO or onsite monitoring. We want to see associate in-house large pharma. Also, want to see experience in phase 3 global study trials in multifunctional areas.

Qualifications

Oncology

Additional Information

All your information will be kept confidential according to EEO guidelines.

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