Senior Research Contract Analyst

Overview

JOB SUMMARY

At Houston Methodist, the Senior Research Contract Analyst position is responsible for supporting the Office of Research Contracts (ORC) by facilitating the contract process for external research collaborations and sponsored activities of all types, while protecting the rights, reputation, and resources of Houston Methodist Research Institute, (HMRI). The Senior Research Contract Analyst works closely with investigators, study staff and corporate legal to negotiate with industry sponsors and university collaborators. Overseeing many types of agreements to include clinical trial agreements, basic and translational sponsored research agreements, expanded access letters of agreement, collaboration agreements, data use agreements, consulting agreements, professional services agreements, and confidentiality agreements, for research and services sponsored by industry, non-profit, and academic sponsors.

Houston Methodist Standard

PATIENT AGE GROUP(S) AND POPULATION(S) SERVEDRefer to departmental "Scope of Service" and "Provision of Care" plans, as applicable, for description of primary age groups and populations served by this job for the respective HM entity.

HOUSTON METHODIST EXPERIENCE EXPECTATIONS

• Provide personalized care and service by consistently demonstrating our I CARE values:
  • INTEGRITY: We are honest and ethical in all we say and do.
  • COMPASSION: We embrace the whole person including emotional, ethical, physical, and spiritual needs.
  • ACCOUNTABILITY: We hold ourselves accountable for all our actions.
  • RESPECT: We treat every individual as a person of worth, dignity, and value.
  • EXCELLENCE: We strive to be the best at what we do and a model for others to emulate.
• Focuses on patient/customer safety
• Delivers personalized service using HM Service Standards
• Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET, Managing Up, Key Words)
• Intentionally rounds with patients/customers to ensure their needs are being met
• Involves patients (customers) in shift/handoff reports byenabling their participation in their plan of care as applicable to the given job

• Displays cultural humility, diversity, equity and inclusion principles

• Actively supports the organization vision, fulfills the mission and abides by the I CARE values

Responsibilities

PRIMARY JOB RESPONSIBILITIES

Job responsibilities labeled EF capture those duties that are essential functions of the job.

PEOPLE - 20%

Provide mentoring, training, and oversight to junior contract staff to ensure compliance and consistency to support organization and department goals. (EF)

Partners with study staff, research administration and other internal partners to draft, negotiate, and finalize contracts and ensure investigator and institutional needs are met. This includes maintaining the highest level of responsiveness and service while communicating contract status updates to investigator and sponsor inquirees on pending agreements. (EF)

Partners collaboratively with Houston Methodist General Counsel, Risk Management and all areas of HMRI Finance to ensure compliance with institutional policies and requirements. (EF)

Serves as primary interface with industry sponsors in the negotiation process and correspondence. (EF)

SERVICE - 40%

Independently manages a portfolio of sponsored project contracts on behalf of HMRI, which includes the development, review, negotiation, and execution of research-related agreements. (EF)

Draft and negotiate complex agreement types and projects to include site agreements, sub-contracts, expanded Access Letters of Agreement, Master Agreements, Consortium Agreements, and Membership Agreements. (EF)

Consult with study staff, investigators and administration as necessary to understand the nature of projects and relationships to identify appropriate agreement terms and conditions. (EF)

QUALITY/SAFETY - 20%

Ensure regulatory compliance by monitoring safety committee approvals are in place, specifically for the Institutional Review Board, (IRB) and Institutional Animal Care and Use Committee, (IACUC). (EF)

Ensure compliance with internal policies, agency guidelines, applicable laws and regulations (including export control). (EF)

Ensure that language related to publication confidentiality, intellectual property, insurance indemnification and subject injury reimbursement are compliant with institutional guidelines and policies. (EF)

Maintain thorough documentation in an efficient and organized manner to facilitate effective knowledge transfer by maintaining progress notes in Methodist Online Research Technology Initiative (MORTI) and diligently updating contract statuses for intake and tracking purposes. (EF)

FINANCE - 10%

Review and negotiate favorable payment terms in research agreements which include ensuring compliance with institutional policies, federal regulations, institutional overhead, fee requirements, and internal budgets for clinical trials. (EF)

GROWTH/INNOVATION - 10%

Provides feedback on errors or issues with MORTI system and participates in process change considerations to impact contract turnaround times. (EF)

Provides training to team on special topics and/or new laws and regulations related to Research Contracts as requested. Seeks opportunities to expand learning beyond baseline competencies with a focus on continual development (EF).

This job description is not intended to be all inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.

Qualifications

EDUCATION REQUIREMENTS

o Bachelors in finance, accounting or related field

o Juris Doctor preferred.

EXPERIENCE REQUIREMENTS

o Five years experience in a legal position, (i.e. paralegal, attorney or in a position negotiating contracts) for an academic research institute, hospital, sponsor, or contract research organization (CRO).

License/Certification

CERTIFICATIONS, LICENSES AND REGISTRATIONS REQUIRED

o None

KSA/ Supplemental Data

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

o Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations

o Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security

o Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles

o Demonstrates high level of oral and written communication skills, including the ability to maintain positive rapport with stakeholders at all levels and in all situations.

o Ability to work under pressure and balance many competing priorities.

o Ability to work with difficult people and in difficult situations.

o Ability to adapt to a rapidly changing environment and to adjust to new requirements.

o Ability to understand contractual issues, relevant contract law and health care policy within clearly defined parameters in accordance with institution policies, federal regulations, and professional ethics.

o Exhibits a comprehensive understanding of HM's interests regarding specific agreements

o Exhibits advanced ability to assess legal risk within the language of a contract, and the ability to provide alternative mitigating language as a means to resolution

 

SUPPLEMENTAL REQUIREMENTS

Work Attire Yes/No

Uniform No

Scrubs No

Business professional Yes

Other (dept approved) No

On-Call* No

*Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Event, etc) regardless of selection above.

Travel**

May require travel within Yes

Houston Metropolitan area

May require travel outside No

of Houston Metropolitan area

**Travel specifications may vary by department.

Please note any other special considerations to this job: _none_________________________

Company Profile

Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies, and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 284 principal investigators and has more than 570 ongoing clinical trials.

Employment Type: FULL_TIME