Study Start-Up Specialist (Remote)

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval.The START Center for Cancer Research is seeking a Study Start-Up Specialist (Remote) who will be dedicated to the start-up process and managing the critical path to site activation to ensure clinical research sites are prepared and have the necessary tools and approvals needed to start a clinical trial.This is a remote role. The annual base salary for this role is $55,000 - $65,000. However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience.Essential ResponsibilitiesPerform broad range of administrative and clerical support tasks of a nature, that require initiative and judgment to make independent decisions. Perform all new study start-up activities from time of site selection to official greenlight activation/ready to enroll status for the START Network sites, when applicable. Work within the forecasted site-specific submission/approval timelines based on site specific information and in accordance with Sponsor expectations and ensure they are met; if forecasted timelines are not reached, provide clear rationale for delays and contingency plans to mitigate impact. Reviews and comply with Standard Operating Procedures and start-up processes in a timely manner and ensure all relevant documents are submitted to Sponsor/CRO and the Investigational Site File (ISF). Anticipate and identify issues during start-up process, resolve minor to moderate issues independently, and escalate complex issues to Director, Central Support Team, Investigators, Sites, and the Sponsor/CRO. Maintain and provide study start-up status updates to the Sponsor/CRO, site-level Investigators, Study Team, and Central Support Team for the START Network sites, when applicable. Facilitate study start-up related meetings, including but not limited to, weekly Study Start-Up Status meetings, Discovery Calls, Pre-Site Initiations meetings, and Site Initiation Visits for the START Network Sites. Attend and assist with departmental meetings, including but not limited to, weekly Protocol Review and Development Committee meetings and Sponsor/Investigator meetings for the START Network Sites as needed. Embrace HubSpot, Veeva Vault, FileMaker, and CTMS system and associated functionality and maintain records related to specific area of assignment. Assist with in-service trainings and new hire trainings for staff. Assist with special projects as assigned. This includes, but is not limited to, conducting research, preparing presentations and documents as requested. Serve as the back-up for the Client Engagement team, when needed. Required Education And ExperienceHigh school diploma/GED required. At least two years’ experience in administrative setting. Proficient working knowledge of Microsoft Word. Strong organizational skills and a sense of timeliness in completing projects; detail oriented. Good spelling, composition and proofreading skills. Must be able to complete tasks with minimal supervision and have ability to understand instructions, compose reports and correspondence. Preferred Education And ExperienceExperience with medical terminology. 1 year of start-up experienceExperience working for a CRO or Site networkPhysical & Travel RequirementsSitting: Must be able to sit for extended periods of time.   Prolonged use of computer, keyboard, and mouse.   Best-in-Class Benefits and PerksBenefitsWe value our employees’ time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including:Comprehensive health coverage: Medical, dental, and vision insurance providedRobust retirement planning: 401(k) plan available with employer matchingFinancial security: Life and disability insurance for added protectionFlexible financial options: Health savings and flexible spending accounts offeredWell-being and work-life balance: Paid time off, flexible schedule, and remote work choices providedPlus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.More about The START Center for Cancer ResearchDeeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world.Learn more at STARTresearch.com.Ready to be part of a team changing the future of cancer treatment?Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.