Clinical Research Analyst IV

Department Overview

The Immune Tolerance Network (ITN) is a National Institutes of Health funded international consortium to facilitate the advancement of clinical trials at all phases to determine the safety, toxicity and efficacy of promising tolerogenic strategies in islet, kidney and liver transplantation, autoimmune diseases and allergy & asthma. The ITN develops and conducts collaborative research projects between academic, governmental and industry researchers which are based on cutting edge immune tolerance research that could not otherwise be conducted. Projects overarch all phases of research and development, are complex (novel assessments/interventions), include many stakeholders, and require multiple sub-contracts which comprise multi-million dollar budgets for a single project.

The ITN CTG acts as a fully functioning Clinical Research Organization (CRO) and is centrally responsible for the development, implementation, and management of all research projects conducted by the ITN. The CTG supports scientific, technical, operational, and administrative functions, including project development, project management, regulatory support, implementation, oversight, and data analysis for the network.

Custom Scope

As a recognized research operations expert, the ITN 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.

Project Management

Functions as a lead with other team members. Convene and lead Study Management Teams (determine agenda, organize and provide meeting materials, prepare meeting minutes). Plan, provide direction, and conduct project team and investigator meetings.

Facilitate and contribute to electronic Case Report Form development. Develop study documents including Manuals of Procedures, source documents, and training materials.

Manages study supplies, ensuring adequate drug, lab and other supplies are available.

Strategic Project Planning

Functions as a lead in development of new processes and protocols with project team for highly complex clinical trials. Oversee and manage protocol amendments.

Conducts large project feasibility assessments. Analyzes risks, strategies and solutions. Develops project timelines and key milestones for assigned projects. Recommend adjustments to budgets and vendor agreements as necessary.

Develops recruitment strategy, budget, and support development of recruitment material content including websites, printed materials, advertising, social media etc. Evaluates the effectiveness of recruitment and retention strategies, proactively implement interventions / corrective actions to meet project goals.

Serves as the primary point of contact for all project related issues. Manage day-to-day activities ensuring protocol and GCP/ICH compliance. Ensure vendor service standards are met in compliance with scope of work maintains interactions, reviews and approves payment requests.

Develops comprehensive Site Training Plan. Oversees and conducts training.

Data Management Activities

Monitor, evaluate and coordinate the flow of data from various interconnected and free-standing systems (e.g. clinical and mechanistic database, sample tracking system, core lab databases, Network Information Systems, ITN Data Warehouse etc.).

Ensure consistent standards (e.g. terms, naming conventions, and data format) are applied across systems.

Ensure reporting is consistent with NIH guidelines, University policies and regulations (e.g. 21CFR part 11, HIPAA).

Lead and manage data cleaning efforts within prescribed data analysis timelines.

Facilitate development of statistical analysis plans.

Facilitate, support, and participate in preparing manuscripts, abstracts, and scientific presentations.

Monitor, evaluate and coordinate data from multiple systems to recommend new actions / procedures from research analysis. Participates in preparation of manuscripts, abstracts and scientific presentations.

General Operations

Assesses policies and processes to ensure proposed project plan is compliant with applicable guidelines. Revises research / trial documents so they are consistent with protocol revisions.

As a technical lead, provides guidance to all levels of management on ways to improve effectiveness. Proactively recommend interventions / corrective actions to meet project goals.

Ensures reporting is consistent with external guidelines, university policies and regulations.

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.