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Search for Jobs by Bharathi Nekkanti

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Sr. Contracts and Grants Analyst (Research)
NEW YORK, CA 100007
Recruited by: Bharathi Nekkanti | Recruiter | DOCS See all my Jobs

  • Hiring Company: DOCS
  • Industry: Research
  • Compensation: to be determined
  • Expires: Dec 30, 2019
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Job Description

Summary:

Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials. Provide support to the clinical team in the pricing, planning, execution and control of grants and contracts.

Principal Responsibilities:

Responsible for analyzing contract requests/needs from operating companies and translating into appropriate contracts/budgets for company sponsored and investigator initiated clinical trial agreements and other relevant legal documents as they relate to various clinical projects.

Provide specialized support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required

Analyze investigator grants for fair market value aligned with regional knowledge and the J&J grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information. Participate in and/or lead the approval escalation of grants as appropriate.

Provide guidance to CROs contracted to negotiate CTAs globally, inclusive of training and supervision.

Determine potential needs for contract amendments and manage amendment lifecycle.

Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.

Work with the global C&G team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language. Assess risks of budget and legal provisions in conjunction with members of the C&G team and support functions and communicate such to stakeholders. Liaise with C&G management, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.

Assume responsibility for all aspects of legal document and metrics tracking.

Review, authorize and/or manage payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.

Adhere to SOPs, ethics and departmental compliance as determined by CDO management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with C&G, CDO and operating companies

Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.

Comply with requests from QA and auditors.

Mentor and train new contract coordinators and analysts

This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.

Qualifications:

- Bachelor's degree in appropriate scientific or business discipline
- 3- 5 years experience and/or equivalent competencies in pharmaceutical industry/clinical research
- Must have a working knowledge of the clinical development process with 2 years of negotiation and contract experience
- Excellent communication skills (both oral and written)
- Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.)
- Familiarity with clinical research processes
- Ability to work effectively in cross function teams
- Strong and proven negotiation and problem resolution skills
- Working knowledge of PCs (MS Office suite at a minimum)
- Fluency in English is required
- Must demonstrate innovative spirit, have strong interpersonal skills, and ability to accomplish substantial tasks with minimal supervision
- Previous experience working in virtual teams preferred