Job Information
Actalent CTMS Database Builder in Orlando, Florida
Clinical Trials Applications Specialist II
Job Description
The Clinical Trials Application Specialist II is knowledgeable in the areas of clinical trial budgets and protocols, Medicare coverage analysis, clinical trial financial processes including invoicing and time and effort, patient and study statuses, and reporting in the Clinical Trial Management System (CTMS). The CTMS is provided as a Core One system by IT. The Clinical Trials Applications Specialist II supports CTMS builds and usage for regions participating in research. The Clinical Trials Applications Specialist II collaborates with operational research unit stakeholders and other shared research services and administrative departments to ensure CTMS builds support compliant, timely, effective, and efficient management of related research activities. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.
Responsibilities
Manage, coordinate, and monitor assigned projects and tasks in CTMS supporting research goals of efficient clinical research study implementation, processes, finances, and reporting.
Review, interpret, and translate study documents such as protocols, informed consents, legal documents, and budgets to accurately and timely provide builds that support the clinical, financial, and compliance operations teams.
Contribute to quality control and assurance functions to ensure that research projects are built and configured efficiently and accurately to support financial recovery and tracking from sponsors and comply with reporting requirements to regulatory, funding, and clinical billing agencies.
Develop and utilize standard tools, methodologies, and templates to aid successful application implementation.
Collaborate with Information Technology to ensure study is available to end-users to ensure timely activation of studies.
Advise leadership on CTMS issues that require escalation and propose recommendations to research leadership.
Participate in the development, updates, and communication of training materials, policies, and procedures related to CTMS.
Consult with stakeholders and partners to solve simple and complex problems related to CTMS builds, applying knowledge of applicable regulations, protocols, budgets, billing compliance and finance requirements, and institutional policies and procedures.
Develop and maintain relationships with operational research departments and other internal/external stakeholders/collaborators.
In coordination with management, orient, train, and provide guidance to new operational staff to achieve departmental goals and objectives.
In collaboration with management, follow, develop, and update established CTMS processes to ensure metrics and tracking, compliance, and document harmonization.
Perform other administrative duties such as business requirement gathering, business process redesign, and application support as necessary.
Update protocol information within the application as amendments occur to the protocol schedule of activities or budget.
Interact with management and staff to provide useful information, guidance, and integrity to CTMS related activities.
Develop service level expectations and assure these expectations are achieved.
Essential Skills
Proficient Microsoft Office Suite skills (Word, Excel, and Outlook)
Knowledge and understanding of Clinical Trial Management System builds
Knowledge and understanding of clinical research protocols and budgets, including Medicare Coverage Analysis
Motivated, organized, and able to function with minimal supervision
Excellent interpersonal skills and a collaborative style necessary for interaction across departments
Ability to work under pressure, meet fixed deadlines, and manage competing priorities
Strong organizational and analytical skills
Ethical and diplomatic with an ability to provide excellent customer service
Knowledge of hospital policies and procedures regarding clinical research
Knowledge of research, IT, or database operations
Additional Skills & Qualifications
Bachelor’s degree in Healthcare, Business Administration, Finance, Computer Science, Information Technology, Nursing, or related field
Two (2) years of full-time experience in building, amending, and maintaining research studies in CTMS or four (4) years of end-user utilization of the CTMS platform for research related job
Three (3) years of experience in healthcare, research, research administration, or related field
General knowledge of Epic as it relates to CTMS interface and functions
Advanced knowledge in Excel (V-Lookups, Pivot Tables, Index, etc.) and Power BI
Work Environment
Fully remote
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.