Clinical Research Start-Up Specialist

Summary

Join Vitalief, a leading site solutions consulting firm, as a Study Start-up/Activation Specialist. You will play a key role in accelerating client study activation, working closely with stakeholders to manage high-priority clinical trials. This remote position requires strong clinical research administration experience, including trial start-up, budgeting, IRB submissions, and OnCore™ CTMS proficiency. You will develop and maintain client relationships, review protocols, negotiate budgets, and ensure compliance with regulations. Vitalief offers a competitive salary, a 100% remote work environment, and a collaborative, entrepreneurial culture focused on professional growth.

Requirements

• Associate or Bachelor's degree required in a health/science related discipline (biology, public health, healthcare administration, nursing, etc.) or equivalent professional experience
• Minimum of 5 years of clinical research administration related experience including extensive experience in trial study start-up, coverage analysis, clinical trial budgeting, financial disclosures, IRB submissions, developing consent forms, and FDA 1572 forms
• Must be fluent in OnCore™ CTMS and have experience performing preliminary “study build” activities including calendar creation and financial console build
• Ability to interpret and apply clinical guidelines including Centers for Medicare and Medicaid, Federal Drug Administration, National Comprehensive Cancer Network, etc
• Strong facilitator with excellent negotiations skills, and ability to overcome obstacles and gain consensus by pulling teams together to work towards common goals and timelines
• Exceptional verbal and written communication and presentation skills
• Proven analytical and critical thinking skills required to effectively quantify financial and operational benefits for performance improvement initiatives, identify risks to achieving projected outcomes, and develop and implement solutions to address data gaps or risks
• Proficient in Microsoft Office (Word, PowerPoint, Excel)
• Highly driven, results oriented, competitive, positive person who thrives in a small, team oriented, fast paced, entrepreneurial environment

Responsibilities

• Working under the direction of a Vitalief Senior Director, play a key role in accelerating our client’s Study Activation by partnering with key stakeholders to direct and manage the execution of high priority clinical trials Study Activation activities
• Develop and maintain long-standing relationships with clients by working in conjunction with other departments of the institution, as well as sponsors, attorneys, governmental agencies, and Principal Investigators, to provide quality services and solutions to meet business objectives
• Review clinical protocols and develop internal budgets. Prepare clinical trial budget documents
• Perform prospective reimbursement (coverage) analysis according to CMS National Coverage Determination Decisions and all applicable billing regulations, third party requirements, industry standards, etc
• Negotiate budgets with sponsors/CROs, interfacing with various internal departments as needed
• Prepare and submit IRB submission documents/consent forms to either a local or central IRB and follow through to approval
• Utilizing OnCore™ CTMS, perform preliminary “study build” including calendar creation and financial console build including protocol related elements, parameters, specifications, subject related items, and milestones for new clinical trials

Preferred Qualifications

Oncology experience is preferred

Benefits

• Salary Range : Market competitive - based on experience level
• Work Location: Job is 100% remote
• Potential “very limited” travel to client locations nationally