Job Title: 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). This role 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 maintains respectful relationships with all.

Responsibilities

• Manage, coordinate, and monitor assigned projects and tasks in CTMS supporting goals of efficient clinical research study implementation, processes, finances, and reporting.
• Review, interpret, and translate study documents such as protocols, informed consents, and budgets to accurately and timely provide builds that support 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 within the application.
• Develop and utilize standard tools, methodologies, and templates to aid successful application implementation.
• Collaborate with Information Technology to ensure study availability to end-users for 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 regulations, protocols, budgets, billing compliance, and institutional policies.
• Develop and maintain relationships with operational research departments and other internal/external stakeholders.
• Orient, train, and provide guidance to new operational staff in coordination 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 ensure 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

This is a fully remote position. Candidates must reside in one of the following states: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas.

Pay and Benefits

The pay range for this position is $75000.00 - $90000.00

Benefits from Day One

Paid Days Off from Day One

Career Development

Whole Person Wellbeing Resources

Mental Health Resources and Support

Pet Insurance*

Debt-free Education* (Certifications and Degrees without out-of-pocket tuition expense)

Nursing Clinical Ladder Program*

Team Based Nursing Model*

Workplace Type

This is a fully remote position.

Application Deadline

This position will be accepting applications until Jan 31, 2025.

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 for other accommodation options.

Salary : $75,000 - $90,000