Senior Research Contracts Administrator

Company: Public Health Institute
Location: Lancaster
Posted on: November 24, 2022

Job Description:

Position SummaryThe Senior Research Contracts Administrator provides technical expertise and oversight, including independently reviewing, drafting, and negotiating research, clinical trials, and other related agreements. In collaboration with Bid and Proposal (B&P), the Office of Research and Agreements Administration, Grants and Contracts, and other administrative staff, the Senior Research Contracts Administrator serves to identify, resolve, and negotiate mitigation strategies for privacy, compliance and business risks associated with a research study and its associated agreements. The Senior Research Contracts Administrator has responsibility for the implementation of processes, systems, and procedures related to contract administration for PHI's clinical research portfolio, serving to: 1) independently manage business processes through administrative and financial systems (including PeopleSoft); 2) responsibly coordinate inter-/intra-departmental contract flow-down and obligations of regulatory compliance; 3) ensure appropriate levels of negotiation and compliance for assigned agreements.This is a remote position.Pay: $93,201 to $116,797 per year. The typical hiring range for this position is $93,201 to $116,797 based on 100% FTE. The starting salary is determined based on the candidate's knowledge, skills, and experience. Essential Duties & ResponsibilitiesAgreements Drafting, Negotiation and Review:

• Responsible for the development and negotiation of Clinical Research Agreements, subawards and subcontracts and amendments, templates, negotiation, and execution of a full contracts management process.
• Provide rigorous monitoring and tracking of regulatory and compliance issues as required by contractual agreements.
• Review and analyze study protocols, budgets, and other documents to formulate appropriate areas to address in contract negotiations.
• Ensure alignment with PHI's classification of transactions policy, contribute to the successful preparation and execution with B&P of a mixed portfolio of incoming awards, subawards, subcontracts, subgrants, other agreements.
• Identify, mitigate, and/or resolve complex research, funder, and other business risks and potential compliance issues in consultation with Office of Chief Legal Counsel.
• Determine appropriate procurement, contractual language and instruments for agreements while ensuring compliance with PHI policies and procedures and as required by funder guidelines, rules, and regulations.
• Advise PHI staff on appropriate contracting agreement types and language.
• Determine appropriate insurance coverage requirements in clinical research and other agreements and incorporate appropriate amounts into contracts and lower tier agreements.
• Draft, review and negotiate non-clinical research agreements, as needed.Cross-department Coordination and Clinical Trials Agreements Training:
  • Communicate and attend meetings with program and PHI central personnel regarding coordination and training.
  • Support consistent, accurate, and complete incorporation applicable policies and processes into standard PHI.
  • In performance of position duties, exercise general processing responsibility for the execution of documents and distribution of fully executed documents to all relevant parties.
  • Provide training and support to B&P staff in the areas of clinical trials studies and complex negotiations.
  • Collaborate with the Office of Research Administration and Agreement, Finance, and other PHI central departments to support post-award administration and feedback.Perform other duties as assigned. Minimum Qualifications
    • At least seven years of related experience in grant, contract, and/or subaward development and management including clinical trials and non-disclosure agreements.
    • Five years of experience in a clinical research related field in the application of data privacy/security, financial compliance and human subjects protection requirements.
    • Three years of progressive experience leading negotiations with clinical trial sponsors and partners with an understanding of key terms in clinical trial agreements and experience developing site-level work orders for performance of clinical trial activities.
    • Bachelor's degree in finance or related field, or substitute with 4 additional years of related experience. Other Qualifications
      • Proficient in terminology of clinical trials, epidemiologic studies, medical records abstractions, disease registration, and public health interventions.
      • Knowledge of IRB determinations and regulatory requirements for human subject protections in research under OHRP and FDA.
      • Experience with budget development and management.
      • Advanced written, verbal, and interpersonal communications; advanced ability to deal with broad and diverse constituencies with advanced customer service orientation and skills.
      • Advanced organizational, presentation and negotiation skills.
      • Ability to work collaboratively in a team environment as well independently.
      • Good computer skills including proficiency in MS Word, Excel, and PowerPoint.
      • 3+ years of supervisory experience in a similar role is preferred.
      • Juris Doctor or Paralegal certificate preferred.
      • CITI Program Training preferred.

Keywords: Public Health Institute, Lancaster , Senior Research Contracts Administrator, Accounting, Auditing , Lancaster, California