Clinical Research Analyst IV

Job Description

Custom Scope

As a recognized research operations expert, the Research Operations Manager (ROM), applies comprehensive knowledge of clinical research protocols and operational processes. The ROM is responsible and accountable for near and long-term operational planning, implementation, and evaluation for all activities associated with assigned network research projects (pre-clinical, clinical, and mechanistic research).

Working within a matrix environment, the ROM works closely with functional groups to ensure work for individual projects is uniform, complete, and successfully delivered operationally and financially to achieve completion on time, within budget and with good quality data. The ROM must be experienced in all phases of the research project lifecycle and possess a thorough understanding of cross-functional research processes including scientific writing principles, Good Clinical Practice and human subjects guidelines, recruitment strategies, financial forecasting and data management principles.

The ROM is responsible for strategic and tactical planning, organization and direction and must have the ability to make high level decisions with minimal input from management.

Pre-Trial Development

Prior to trial development, the ROM participates in strategic discussions and tactical planning regarding design, regulatory, operational, contractual, and financial aspects of research projects. This includes providing an in-depth feasibility analysis for the project which identifies project risks and recommends strategies for project development, regulatory requirements, and efficient study implementation and conduct, financial and resource management, and timelines.

Trial Development

During trial development, the ROM provides matrix management of functional area representatives within a virtual environment and must establish working relationships with key opinion leaders (KOLs), medical staff, clinical scientists, regulatory officers, data managers and biostatisticians to support development activities.

Study Conduct

During conduct, the ROM oversees all aspects of study-related activities, monitors investigative sites, establishes and maintains metrics to monitor trial progress, prepares detailed status reports, and follows up with the project team and ITN leadership to determine appropriate actions.

They are accountable for managing the study budget, ensuring the project remains within scope, and that any out of scope activities are identified and handled appropriately. The ROM also oversees adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports, communications with investigators, regulatory affairs, and external stakeholders.

Data Analysis

During Analysis, the ROM is responsible for instituting data cleaning activities, managing the timeline for data review and analysis. This requires a proficient understanding of the various methodologies and strategies involved with highly complex quantitative and qualitative data analysis and the ability to interpret sophisticated data sets.

Decision-Making and Accountability

Decisions made by the ROM have the potential to long-lasting operational and fiscal ramifications for projects, network collaborations, the ITN, and the University. Errors, oversights, or lack of planning at this level may result in loss of funding to the ITN, University and other collaborating academic institutions. Mistakes can result in critical delays and increased costs which can jeopardize the project.

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