Advanced knowledge of clinical research practices and regulatory requirements.
Proven ability to lead multiple projects in a fast-paced environment.
Strong critical thinking skills for problem evaluation and solution identification.
Excellent verbal and written communication skills, including active listening and persuasion.
Advanced interpersonal skills for teamwork and leadership.
Proficient in MS Office Suite and clinical data management systems.
Experience in developing study manuals and case report forms.
Responsibilities
Lead Study Management Teams and organize project meetings.
Develop study documents and facilitate electronic Case Report Form creation.
Manage study supplies and ensure availability of necessary resources.
Oversee protocol amendments and conduct feasibility assessments for projects.
Develop recruitment strategies and evaluate their effectiveness.
Serve as the primary contact for project-related issues and ensure compliance with protocols.
Monitor data flow and coordinate data management activities across systems.
Benefits
Comprehensive training and development opportunities.
Flexible work environment with potential for remote work.
Access to cutting-edge research and clinical trial methodologies.
Collaborative team culture focused on innovation and improvement.
Opportunities for professional growth and advancement.
Full Job Description
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.
Responsibilities
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.
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.
