Clinical Research Start-Up Specialist

Overview
Vitalief is a leading site solutions consulting firm focused on improving the value and contribution of clinical trial sites across the drug development lifecycle.  We offer integrated strategic/operational consulting and Functional Service Provider (FSP) resourcing and outsourcing services that enhance clinical trials and improve patient outcomes.  

We are seeking a client facing, problem-solving and hands-on clinical research professional to become an integral member of our exceptional Client Services Delivery Team.  The initial focus of this role will be to function as a Study Start-up/Activation Specialist, working closely with Vitalief’s delivery team with one of our premier clients to significantly reduce their time to trial activation.

Why Vitalief?

• You can actively contribute to our clients’ mission of advancing scientific discoveries that have the potential to change patients' lives for the better.
• Our team of real-world practitioners brings business and domain expertise to provide more efficient, higher-quality clinical trials and unmatched value to Sponsors, CROs, academic sites, independent sites, and site networks. Our unique, fully integrated, and customized approach accelerates and enhances clinical research.
• Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees; and we encourage challenging the status quo with novel thinking.
• Join a culture that is highly collaborative, entrepreneurial, and enthusiastic about expediting the growth of Vitalief and be highly rewarded for our accomplishments as a team.

• 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.

• 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.
• Oncology experience is preferred.
• 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.

PHYSICAL DEMANDS: Prolonged periods of sitting at a desk and working at a computer.  Standing, walking, visual perception, talking and hearing.  Lifting up to 20lbs.  Limited travel to various physical locations within the USA.