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Clinical Research, Biotechnology, Healthcare, Pharmaceuticals

Clinical Research Systems Study Build Specialist

Lake Mary, FLOnsiteFull TimePosted 1 month agoVisa sponsorship available

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Required skills

  • CTMS
  • Clinical conductor
  • Study protocol
  • Contract terms
  • Study build guidelines
  • Billing determinations
  • Sponsor budget
  • Clinical trial agreement
  • Cash flow
  • Process standardization

Nice to have

  • Bachelor’s degree in accounting
  • finance
  • business
  • sciences
  • related field

Role summary

Alcanza is seeking a Clinical Research Systems Study Build Specialist to create and maintain financial study builds in their CTMS for their network of clinical research sites. This role involves managing a ticketing system, collaborating with Operations and Finance to prioritize and complete builds according to study protocols and contracts, and ensuring accurate revenue capture. The specialist will also participate in process improvement initiatives, system integrations, and quality control to maximize cash flow and support the study startup process. A Bachelor's degree in a related field or an Associate degree with equivalent experience, plus 2+ years of clinical research experience and CTMS experience, is required.

Clinical Research Systems Study Build Specialist

Department: Operations

Employment Type: Full Time

Location: Alcanza Corporate

Reporting To: DONNA-MARIE TUTTLE



Description

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.
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