Budget and Contracts Specialist

Job Description

Title: Budget and Contracts Specialist

Pay: $65,000.00 – $75,000.00 per year

Schedule: 8-hour shift, Monday to Friday

Benefits: Health insurance, Paid time off, Dental insurance, Vision insurance, 401(k) matching

Essential Duties and Responsibilities:

  • Review, analyze and negotiation of CRO/Sponsor budgets
  • Review proposed budgets in conjunction with study protocol, startup and other site sponsor determined site requirements
  • Determine company costs associated with required study activities in collaboration with finance and clinical team leaders
  • Establish proposed counter offers to achieve desired financial margins
  • Respond to sponsor/CROs with initial counter offers and revisions in a timely basis
  • Prioritize and manage multiple budgets in workflow to meet study start up timing goals
  • Review and analyze proposed sponsor clinical trial agreements
  • Identify all contract terms that require modification based on corporate SOPs and legal guidelines
  • Collaborate with in house counsel on proposed language changes
  • Respond to sponsor/CROs with initial counter offers and revisions in a timely basis
  • Prioritize and manage multiple contracts in workflow to meet study start up timing goals
  • Track all activity in company CRM database, providing weekly reporting to management on status of all pending budgets and contracts
  • Oversee the internal contract execution process, including but not limited to signatures and uploading to the contract management system and other specified areas
  • Develop and enhance relationships with internal clients, internal stakeholders, vendors, and sites and effectively communicate with them.
  • This will be an in-office job in the Dallas Location.

  

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    Clinical Research Coordinator

    Job Description

    Title: Clinical Research Coordinator

    Location: Dallas, Texas Metro Area

    Reports to: Clinical Operations Manager

    Summary:

    We are looking for candidates with medical backgrounds and excellent interpersonal skills for the position of Clinical Research Coordinator (CRC). This role is responsible for the successful conduct of clinical trials under the oversight of the principal investigator. The CRC will be responsible for both clinical and administrative duties related to the conduct of clinical research at the site.

    Clinical Research Nurse Coordinator Responsibilities:

    • Abide by local, state, GCP, ICH and FDA guidelines and regulations for the conduct of clinical trials.
    • Overseeing the smooth running of clinical trials at site in collaboration with study investigator(s).
    • Complete all required organization and study specific training in timely manner, including attendance at offsite investigator meetings
    • Supervision and training of site research site staff, including study coordinators, research assistants and tab technicians
    • Participate in the planning and conduct of research participant recruitment efforts
    • Conduct the proper consenting of research participants
    • Collecting source obtained from research and transcribe into case report forms.
    • Perform medically qualified clinical procedures such as vital signs, EKG and phlebotomy
    • Process study labs per requirements
    • Provide clinical research training and mentoring to study team.
    • Provide responsive and diligent collaboration with sponsor/CRO study teams, including prompt resolution of queries and other action items.
    • Monitoring research participants to ensure adherence to study participation.
    • Ensuring that the necessary supplies and equipment for a study are in stock and in working order.
    • Engaging with subjects and understanding their concerns.

     

     

    Clinical Research Coordinator Requirements:

    • 3 years’ experience as a clinical research coordinator on phase II & III studies
    • Currently trained or willing to be trained in phlebotomy, performance of vital signs, medical history collection, and administration of EKGs
    • Attention to detail
    • Exceptional interpersonal and customer service skills
    • Outstanding written and verbal communication
    • Excellent organizational skill
    • Willingness to continually self-educate
    • Pluses
      • Experience as a research coordinator in pediatrics and/or women’s health studies
      • Fluency in Spanish

    Compensation: Dependent on medical/clinical qualifications and experience

     

     

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