Clinical Research Analyst IV

Job Description

Job Summary

Involves the development of and ensures compliance with clinical study protocols that involve human subjects. Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures and good clinical practice and research regulations. May be responsible for finances and vendor selection.

Qualifications

Required Qualifications - Advanced knowledge of clinical research practices and philosophy, and ability to apply knowledge and skills to recommend improvements in methodology. Advanced knowledge of regulatory requirements. - Advanced ability to effectively lead one or more projects with competing to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities. - In depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems. - Advanced communication skills; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. - Advanced interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members. Works well with others to achieve common goals. - Proven ability to perform all commonly applicable functions in word processing and spreadsheet software (e.g. MS Office Suite: Word, Excel, PowerPoint, Visio, Endnote, Outlook). Proficient knowledge of clinical information and documentation application programs. Experience utilizing Electronic Data Capture systems and/or Clinical Trial Management systems to capture study data. - Experience developing study manuals of procedures, source documents, and case report forms. - In depth ability to work collaboratively with other cross-functional teams. In depth ability to interface, collaborate and influence / persuade other members of an extended study team. - Knowledge of medical therapeutic area and medical/scientific terminology. - Ability to travel to annual meetings, conferences and investigative sites (up to 25% total). Required Education and Experience - Bachelor's degree in related area and 5 years experience in clinical research, administrative analysis or operations research; / or equivalent combination of education / experience / training. Preferred Education and Experience - Master's degree in related area and more than 5 years' experience in clinical research, administrative analysis or operations research or equivalent combination of education / experience / training. Preferred Certifications - Research (CCRP, CCRC, CCRA) and/or Project Management (PMP, Six Sigma) Certification. Licenses None listed.

License / Certification

Certified Professional Academy of Clinical Research Professionals, Project Management Professional Project Management Institute, Society of Clinical Research Associates