Clinical Research Associate at Denver

Clinical Research Associate

Job Description: Responsible for supportingColorado Cancer Research Program(CCRP) in all aspects of subject data management. Key tasks include but are not limited to:

Evaluation and abstraction of source documentation, case report form completion, database use and management.

Utilizes multiple data capture/retrieval systems and interacts with a variety of health care delivery systems to identify, track, evaluate, collate, analyze, submit and amend subject data. Data may include but is not limited to paper data, electronic data and biological specimens.

Responsible for processing, tracking, and shipment of biological specimens, including tissue and blood samples.

Collaborates closely with the CCRP Clinical Research Team, which may include Clinical Research Coordinators, the Principal Investigator (PI), the Oncology Manager, Sub-Investigators and Quality Assurance personnel to ensure that key federal/state/local regulatory objectives are met; and that ethical obligations are kept.

Develops, establishes and maintains productive relationships with CCRP colleagues and all external customers and contacts at affiliate sites to achieve essential research outcomes.

Assists the clinical research team in preparation for external audits and is responsible for the quality and completeness of subject data.

Performs internal chart audits and resolves data queries accurately and expediently.

Participates in project-related and departmental meetings as required. May participate in cross-functional teams.

Ensuresadherence to Good Clinical Practices and compliance with all CCRP policies and procedures.

Responsible for completing and maintaining certification in human subjects training and biosafety training within required timeframes.

May attend relevant symposia, conferences and scientific meetings as necessary.

Performs other duties as requested.

Qualifications:

Bachelors degree and experience in health research and/or healthcare-related field preferred, or an equivalent combination of training & experience.

Experience using health-care based clinical information systems preferred.

Highly proficient with multiple computer applications, including but not limited to: Microsoft Word, Microsoft Excel, spreadsheet management, PDF file creation/use, online database use/maintenance, network file maintenance & management, and custom report generation.

Experience with interpreting complex protocols, subject records, and federal, state, and local regulations preferred.

Understanding of current GCP/ICH guidelines applicable to the conduct of clinical research.

Demonstrated knowledge of medical terminology.

Excellent written and oral communication skills.

This individual must be able to work as a member of a team, manage conflicts and resolve problems effectively.

Detail-oriented organizational skills.

Ability to complete tasks in an accurate and timely manner.

Ability to handle competing priorities within multiple, complex clinical trials.

Valid drivers license; ability to travel to affiliate sites using individuals own transportation may be required.

Essential Functions:

Frequent use of computer, telephone and general office equipment (copiers, faxes, etc.) required.

Frequent sitting, standing, walking, reading of documents, use of computer monitor screen and mouse, reaching with hands and arms, talking, writing and listening required.

Occasional bending, grasping, twisting, carrying, stooping, kneeling, and crouching required.

Frequent lifting and/or moving up to 20 pounds and occasional lifting and/or moving up to 40 pounds.

Problem-solving skills and ability to independently analyze and interpret data required.

Clear oral and written communication skills required for all interactions on behalf of CCRP with the public, physicians, affiliates and staff.

Ability to travel locally to affiliate sites required.

Country: USA, State: Colorado, City: Denver, Company: Colorado Cancer Research Program.