Clinical Research Analyst IV

UCSF•San Francisco, CA

3d•$110,000 - $140,000

About The Position

The Clinical Research Analyst IV develops clinical study protocols involving human subjects and ensures compliance with them. The role oversees and resolves operational aspects of clinical trials with project teams, following standard operating procedures, good clinical practice, and research regulations. The position may also be responsible for finances and vendor selection. As a project lead, the analyst coordinates study teams and meetings, contributes to electronic case report form development, creates study documents and training materials, and manages study supplies. The role leads planning for highly complex trials, including feasibility assessments, risk and strategy analysis, timelines, milestones, budgets, vendor agreements, recruitment plans, and protocol amendments. It serves as the primary contact for project issues and oversees daily activities, vendor performance, site training, and compliance. The analyst coordinates data across interconnected and standalone systems, maintains consistent data standards and compliant reporting, leads data cleaning, and facilitates statistical analysis plans and scientific publications and presentations. The role also evaluates policies and processes, updates trial documents to reflect protocol changes, and advises management on ways to improve effectiveness and meet project goals.

Requirements

Advanced knowledge of clinical research practices and philosophy, with the ability to apply expertise to recommend methodological improvements.
Advanced knowledge of regulatory requirements.
Advanced ability to lead one or more projects while managing competing demands in a fast-paced, dynamic environment and adapting to changing priorities.
In-depth critical-thinking skills to evaluate issues, identify potential solutions, and address complex or new problems creatively.
Advanced verbal and written communication, active listening, critical-thinking, persuasion, advising, and counseling skills; ability to communicate clearly and concisely.
Advanced interpersonal skills, including problem-solving, teamwork development, and leadership with other team members.
Ability to work collaboratively across functions and influence and persuade members of an extended study team.
Proven ability to use common word-processing and spreadsheet software, including MS Office applications such as Word, Excel, PowerPoint, Visio, EndNote, and Outlook.
Proficient knowledge of clinical information and documentation applications, and experience using 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.
Knowledge of a medical therapeutic area and medical/scientific terminology.
Ability to travel to annual meetings, conferences, and investigative sites, up to 25% of the time.
Bachelor's degree in a related area and five years of experience in clinical research, administrative analysis, or operations research, or an equivalent combination of education, experience, and training.

Nice To Haves

Master’s degree in a related area and more than five years of experience in clinical research, administrative analysis, or operations research, or an equivalent combination of education, experience, and training.
Research certification such as CCRP, CCRC, or CCRA, and/or project management certification such as PMP or Six Sigma.

Responsibilities

Lead Study Management Team meetings, including setting agendas, organizing materials, and preparing minutes; plan and conduct project team and investigator meetings.
Facilitate and contribute to electronic Case Report Form development and develop Manuals of Procedures, source documents, and training materials.
Manage study supplies and ensure adequate drug, laboratory, and other supplies are available.
Lead development of processes and protocols for highly complex clinical trials and oversee protocol amendments.
Conduct project feasibility assessments; analyze risks, strategies, and solutions; develop timelines and milestones; and recommend budget and vendor-agreement adjustments.
Develop recruitment strategies and budgets, support recruitment material development, assess recruitment and retention effectiveness, and implement corrective actions as needed.
Serve as the primary contact for project-related issues and manage day-to-day activities to ensure protocol and GCP/ICH compliance.
Ensure vendors meet service standards and scope-of-work requirements; maintain interactions and review and approve payment requests.
Develop comprehensive site training plans and oversee and conduct training.
Monitor, evaluate, and coordinate data flows among clinical, mechanistic, sample-tracking, core-lab, network, and other information systems.
Ensure consistent data standards across systems and reporting compliance with NIH guidelines, university policies, and regulations such as 21 CFR Part 11 and HIPAA.
Lead data-cleaning efforts within prescribed analysis timelines and facilitate development of statistical analysis plans.
Facilitate, support, and participate in the preparation of manuscripts, abstracts, and scientific presentations.
Use analysis of data from multiple systems to recommend new actions or procedures.
Assess policies and processes for compliance with applicable guidelines and revise research or trial documents to reflect protocol revisions.
Provide technical leadership and guidance to management on improving effectiveness, and recommend interventions or corrective actions to meet project goals.
Ensure reporting complies with external guidelines, university policies, and regulations.