Clinical Data Coordinator

Proclinical is currently recruiting for a Clinical Data Coordinator with a pharmaceutical company located in Sacramento, CA.

Job Responsibilities:

• Ensuring patient safety by entering timely data
• Interpreting the protocol and advising the treating physician regarding reportable requirements;
• Assessing and documenting side effects related to study treatment;
• Managing monitor, data management, and safety queries as well as data cuts;
• Perform investigator initiated trial audits; aid in providing audit finding responses
• Abstract data from necessary source documentation to complete flow sheets, case report forms, regulatory, CTSU database and other documents required by the sponsor.
• Scheduling monitors and auditors and facilitating their visits to ensure contract compliance;
• Assist in submitting annual FDA IND reports and quarterly sponsor SAE reconciliations.
• Verify the accurate preparation of amendments, modifications, and revisions.
• Report serious adverse events and deviations according to study sponsor, FDA, NCI, and Human Subjects Review Committee guidelines.
• Knowledge and understanding of disease processes as applied to human clinical research.
• Knowledge of clinical research trials regulations (e.g., Food and Drug Administration [FDA] and Office for Human Research Protections [OHRP]) is essential.
• Knowledge of regulatory processes as well as a working knowledge of data management activities as applied to clinical trial coordination.
• Knowledge of basic anatomy, medical terminology and ability to interpret physicians' notes, medical records, laboratory and scan results.
• Working knowledge with Microsoft Office Suite: Word, Excel, Outlook, Access, etc.
• Ensuring patient safety by entering timely data
• Interpreting the protocol and advising the treating physician regarding reportable requirements;
• Assessing and documenting side effects related to study treatment;
• Managing monitor, data management, and safety queries as well as data cuts;
• Perform investigator initiated trial audits; aid in providing audit finding responses
• Abstract data from necessary source documentation to complete flow sheets, case report forms, regulatory, CTSU database and other documents required by the sponsor.
• Scheduling monitors and auditors and facilitating their visits to ensure contract compliance;
• Assist in submitting annual FDA IND reports and quarterly sponsor SAE reconciliations.
• Verify the accurate preparation of amendments, modifications, and revisions.
• Report serious adverse events and deviations according to study sponsor, FDA, NCI, and Human Subjects Review Committee guidelines

Skills and Requirements:

• Knowledge and understanding of disease processes as applied to human clinical research.
• Knowledge of clinical research trials regulations (e.g., Food and Drug Administration [FDA] and Office for Human Research Protections [OHRP]) is essential.
• Knowledge of regulatory processes as well as a working knowledge of data management activities as applied to clinical trial coordination.
• Knowledge of basic anatomy, medical terminology and ability to interpret physicians' notes, medical records, laboratory and scan results.
• Working knowledge with Microsoft Office Suite: Word, Excel, Outlook, Access, etc.

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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