Senior Research Contracts Administrator
Company: Public Health Institute
Posted on: November 24, 2022
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
- 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
- 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
- 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
- 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
- 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
- Ability to work collaboratively in a team environment as well
- Good computer skills including proficiency in MS Word, Excel,
- 3+ years of supervisory experience in a similar role is
- Juris Doctor or Paralegal certificate preferred.
- CITI Program Training preferred.
Keywords: Public Health Institute, Lancaster , Senior Research Contracts Administrator, Accounting, Auditing , Lancaster, California
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