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Clinical Research, Biotechnology, Healthcare, Pharmaceuticals

Clinical Research Systems Study Build Specialist

RemoteHybridFull TimePosted 1 month agoVisa sponsorship availableHidden Gem · Himalayas

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Required skills

  • CTMS
  • Clinical Conductor
  • Clinical research industry experience
  • Bachelor’s degree
  • Microsoft applications
  • email
  • electronic health records
  • web applications
  • 40+ wpm
  • math proficiency

Nice to have

  • accounting
  • finance
  • business
  • sciences
  • process standardization
  • system migrations

Role summary

Alcanza Clinical Research is seeking a Clinical Systems Study Build Specialist to create and maintain financial study builds in their CTMS across their network. This role is crucial for the study startup process, ensuring accurate revenue capture and timely funding. Responsibilities include managing build requests, collaborating with internal teams (Operations, Finance, Budgets/Contracts, Systems) to align study protocols, contracts, and budgets, and enforcing quality control. The specialist will also participate in process improvement initiatives, system integrations, and the integration of new sites. A Bachelor's degree in a related field or equivalent experience, plus 2+ years in clinical research and CTMS experience, is required.

Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TN, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.The Clinical Systems Study Build Specialist will be responsible for the creation and maintenance of financial study builds in the Clinical Trial Management System (CTMS) for the Alcanza Clinical Research site network. Reporting to the Clinical Systems Study Build Manager (or their delegate), the candidate will manage a ticketing system of requests for new builds and revisions, partner with Operations and Finance colleagues to prioritize study builds, and complete builds timely and in accordance with the study protocol. This position is a crucial contributor to Alcanza’s Study Startup process and ability to record revenue and receive timely funding for its services performed.

Key Responsibilities

Essential Job Duties:
  • Complete high-quality Clinical study builds in the CTMS system(s) in accordance with the study protocol, contract terms, and Alcanza study build guidelines.
  • Collaborate with internal teams to ensure billing determinations, sponsor budget, and clinical trial agreement are congruent with the clinical trial protocol and site requirements to capture all possible revenue.
  • Enforce a Quality Control process with Operations and Finance colleagues to maintain integrity of the study build and maximize future cash flow.
  • Identify any protocol requirements not identified in Clinical Trial Agreement and collaborate with operation and financial leads to ensure contractual obligations are met.
  • Partner with Operations, Budgets/Contracts, Systems, and Finance colleagues to implement best practices in a scalable manner.
  • Active participation in special projects, including but not limited to process standardization, system migrations, system integrations (e.g. CTMS and eSource) and integration of newly acquired sites’ processes and systems, as needed.
  • Identify opportunities to improve business processes and efficiencies.
  • Maintain a positive, results oriented work environment, building partnerships within the team and across the organization at large, modeling teamwork.
  • Perform all other duties that may be requested or assigned.

Skills, Knowledge and Expertise

Minimum Qualifications: Bachelor’s degree in accounting, finance, business, sciences or related field preferred (associate degree required) AND 2+ years of clinical research industry experience, OR an equivalent combination of education and experience. Experience entering calendar details, study budget elements and financials into a CTMS system is required. Experience with clinical conductor required. Required Skills:
  • Proficiency with computer applications such as Microsoft applications, email, electronic health records, and web applications and the ability to type proficiently (40+ wpm).
  • Strong organizational skills, time management, attention to detail, and math proficiency.
  • Well-developed written and verbal communication skills .
  • Well-developed interpersonal and listening skills and the ability to work independently as well as with co-workers, subjects, managers, and external customers.
  • Ability to effectively manage multiple tasks and adapt to changes in workloads and priorities.
  • Ability to be professional, respectful of others, self-motivated, and exemplify a strong work ethic.
  • A high degree of integrity and dependability.
  • Ability to work under minimal supervision, identify problems and implement solutions.
  • Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with privacy and company guidelines.

Benefits

  • Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
  • Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.

Originally posted on Himalayas

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