Research Contracts Manager

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The Public Health Institute (PHI) is an independent, nonprofit organization dedicated to promoting health, well-being, and quality of life for people throughout California, across the nation and around the world. As one of the largest and most comprehensive public health organizations in the nation, we are at the forefront of research and innovations to improve the efficacy of public health statewide, nationally, and internationally.

Position Summary

The Research Contracts Manager provides leadership, 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 Research Contracts Manager serves to identify, resolve, and negotiate mitigation strategies for privacy, compliance and business risks associated with a research study and its associated agreements. The Research Contracts Manager 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. The Research Contracts Manager will provide training and supervision to staff members.

This is a remote position.

Full salary range for this position: $104,733 to $159,181 per year. The typical hiring range for this position is from $104,733 (minimum) to $131,957 (midpoint), based on 100% FTE. The starting salary is determined based on the candidate’s knowledge, skills, experience, as well as budget availability.

Employment Type: Full Time

Essential Duties & Responsibilities

Agreements Drafting, Negotiation and Review:

• Supervise staff including coordination of activities; communication of pre-award and contracting policies and procedures to be implemented; evaluation of performance; and development of training plans.
• Responsible for the development and negotiation of Clinical Research Agreements, and amendments, templates, negotiation, and execution of a full contracts management process.
• Serve as the point of contact in the Bid & Proposal team for incoming awards for PHI’s clinical research programs.
• Provide leadership and support in developing PHI’s templates for clinical research agreements and performing periodic reviews and updates of the terms through collaboration with PHI’s Central departments, programs, and other stakeholders.
• 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 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.
• Support Bid & Proposal team strategic initiatives, including system procurement and development, strategic planning, and other initiatives as discussed.
• 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 templates.
• 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 contract negotiation with minimum three years of supervisory 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, including areas of 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 business, 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.

FAIR LABOR STANDARDS ACT (FLSA) STATUS

This position is classified as exempt based on the job duties. However, based on the FTE, salary level of the employee, or federal/state/local laws, the employee may be classified as nonexempt.

PHI WORKFORCE MANDATORY COVID-19 VACCINATION POLICY

Per the PHI Workforce Mandatory COVID-19 Vaccination Policy, it is a condition of employment for all domestic based employees to be fully vaccinated for COVID-19, unless they are granted a reasonable accommodation under applicable law.

New hires need to provide proof of full vaccination prior to their start date or apply for an exemption/accommodation within three business days after their start date. Depending on the circumstances, new hires who do not comply with this Policy, or who cannot be reasonably accommodated, will either have their employment suspended or terminated. Candidates who are non-compliant will have their offers rescinded.

EEO Statement

The Public Health Institute is committed to a policy that provides equal employment opportunities to all employees and applicants for employment without regard to race, color, sex, religion, national origin, ancestry, age, marital status, pregnancy, medical condition including genetic characteristics, physical or mental disability, veteran status, gender identification and expression, sexual orientation, and to make all employment decisions so as to further this principle of equal employment opportunity. To this end, the PHI will not discriminate against any employee or applicant for employment because of race, color, sex, religion, national origin, ancestry, age, marital status, pregnancy, medical condition including genetic characteristics, physical or mental disability, veteran status, gender identification and expression, sexual orientation, and will take affirmative action to ensure that applicants are offered employment and employees are treated during employment without regard to these characteristics.

For further information regarding Equal Employment Opportunity, copy and paste the following URL into your web browser: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

ADA Statement:

The Public Health Institute is committed to providing access and reasonable accommodation in its services, programs, activities and employment for individuals with disabilities. To request disability accommodation in the application process, contact the Recruitment Team at least 48 hours in advance at Recruitment@phi.org.

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We’re so pleased the Public Health Institute is an organization you would like to work with. Do you have questions about this opportunity? If so, email our recruitment team at Recruitment@phi.org.

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