Coordinator II - Clinical Research - Cardiovascular

Responsibilities

• Responsible for clinical and/or data management of complex protocols.
• Involved in activities such as recruitment, screening, obtaining informed consent, reviewing source documents, data collection, data entry, query resolution, triggering financial payments, study startup/close out.
• Serves as a liaison with study sponsors.
• Collects, verifies, organizes, completes and records clinical information and data in case report forms.
• Involved in data-related activities such as CRF tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation, resolve queries and safety coding.
• Aids in subject follow-up for clinical protocols and documents/report clinical study progress as required.
• Obtains all reports and submits data forms and pathology and radiology materials according to protocol requirements.
• Conducts protocol administration quality control monitoring, enforcement and database maintenance.
• May participate in site initiation, interim monitoring, and study close out visits with sponsor and FDA initiated audits as needed.
• May handle and label samples and ship samples according to protocol requirements.
• Facilitates ongoing setup and closing of clinical protocols.
• Aids in the creation and implementation of tools to continuously monitor team performance.
• Communicates departmental measurable improvements and positive trends to management.
• Aids in the creation and implementation of departmental operating procedures.
• Represents coordination team in a variety of meetings.
• Assists in the creation of business development proposals by supplying coordination related information and costs.
• Aids in the conduct of monthly quality checks of recorded and submitted data.
• Verifies proper documentation of the data, deviations, and compliance with deadlines.
• Identifies and documents regulatory and protocol deviation findings, including IRB reporting.
• Provides assistance as needed to peers to ensure that study deadlines are met.
• Identifies data management project issues and alerts leadership and makes recommendations.
• Maintains communication with supervisor regarding regulatory and safety issues as well as any concerns that reflect upon Good Clinical Practices.
• Performs other related duties as assigned.

Qualifications

• Bachelor's Degree in Health Science or 4 years of health science-related experience - Required
• 2 years of progressively responsible clinical/clinical research or data management experience - Required
• Knowledgeable of ICH/GCP, FDA regulations for clinical trials and strong project management skills - Preferred
• Strong writing and computer skills, including, MS Word, Excel, Access, EDC (electronic data capture) - Preferred

Pay

(Commensurate with experience)

Schedule

(Day shift)

Benefits

(Varies)