- Review New Study routing forms and essential study start-up documents.
- Conduct itemized cost analysis and interpretation of clinical protocols into budget milestones.
- Provide accurate patient cost descriptions for the Informed Consent Form (ICF) to be submitted to the Institutional Review Board (IRB).
- Update budget, milestones, and ICF information as necessary per contract/protocol amendments.
- Collaborate closely with coverage analysis team, contract analysts, regulatory team, program managers, and internal finance groups.
- Manage large volume workflow across multiple research programs, each of which function differently.
- Develop study budgets from clinical study protocols using various software tools.
- Complete full evaluation and integration of internal costs during the setup of new clinical studies.
- Revise study budgets following revision of study protocols or re-assessment of study cost.
- Communicate with Contracts Analysts to integrate study budget information into clinical trial agreements; may initiate or participate in contract negotiation process.
- Independently initiate or update the coverage determination for each study as applicable.
- Communicate specific study billing structure to clinical teams and service providers.
- Participate in the administration of study-subject related billing and support auditing of billing records.
- Collect and maintain complete records and statistics on expenses and payments.
- Regularly monitor compliance of clinical expense to predetermined budget/billing plan and/or budgets and agreements.
- Establish and promote positive working relationships within both ORA and the research departments, throughout the hospital, and between other institutions involved in clinical research.
- Proficiency in Microsoft Applications (Excel) and/or Clinical Trial Management System.
- Bachelor's Degree in Accounting or related field preferred.
- Minimum of 2 years of experience in research, particularly in clinical trials.
- Strong negotiation and billing experience with sponsors.
- Excellent organizational and communication skills.
- Ability to manage multiple priorities and deadlines effectively.
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Clinical Trial Contract Specialist - Anaheim, United States - LHH Recruitment Solutions
Description
Job Description
Job DescriptionThe Clinical Trial Contract Specialist will play a pivotal role in the timely and accurate preparation and maintenance of budget templates for sponsored clinical trials. This includes a comprehensive review of study protocols, comparative analysis of sponsor budgets, and ensuring alignment with payment milestones in the Clinical Trial Management System.
Responsibilities:
Essential Functions:
Requirements:
Schedule: Monday to Friday, 9 am to 5 pm (Full time), 3 month contract with possible extension, Hybrid 2 days in office 3 days WFH
Pay Details: $30.00 to $36.00 per hourSearch managed by: Joanna Calderon
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
