Research Contract Analyst

At Houston Methodist, the Research Contract Analyst position is responsible for various duties, which include contract review and negotiation, and analysis of contracts submitted to the Houston Methodist Research Institute (HMRI) Office of Research Contracts. This position is responsible for reviewing various types of agreements which include but are not limited to, 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.

FLSA STATUS

Exempt

QUALIFICATIONS

EDUCATION

• Juris Doctor degree

EXPERIENCE

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

SKILLS AND ABILITIES

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

• 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

• 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

• Demonstrates effective oral and written communication skills, including the ability to maintain positive rapport with personnel at all levels and in all situations

• Ability to work under pressure and balance many competing priorities

• Ability to work with difficult people and in difficult situations

• Ability to adapt to a rapidly changing environment and to adjust to new requirements

• 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

• Exhibits a comprehensive understanding of HM interests regarding specific agreements

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

ESSENTIAL FUNCTIONS

PEOPLE ESSENTIAL FUNCTIONS

• Collaborates with study staff, research administration and other internal partners to draft, negotiate, and finalize contracts and ensure investigator and institutional needs are met, which includes maintaining the highest level of responsiveness and service while communicating contract status updates to investigator and sponsor inquiries on pending agreements.

• Partners collaboratively with Houston Methodist General Counsel, Risk Management, and all areas of HMRI Finance to ensure compliance with institutional policies. Functions as a liaison with industry sponsors in the negotiation processes and correspondence.

• Contributes towards improvement of department scores for employee engagement, i.e. peer-to-peer accountability.

SERVICE ESSENTIAL FUNCTIONS

• Oversees a portfolio of contracts related to research on behalf of Houston Methodist Research Institute. Drafts, reviews, negotiates, and finalizes research related agreements.

• Confers with study staff, investigators, and administration, as necessary, to understand the nature of projects and relationships to identify appropriate agreement terms and conditions.

• Maintains thorough documentation in an efficient and organized manner to facilitate effective knowledge transfer.

• Maintains progress notes in the Methodist Online Research Technology Initiative (MORTI) system for all contracts in a timely manner and diligently updates contract statues in MORTI for tracking purposes.

• Provides management, department, and Principal Investigator (PI) with status updates on assigned agreements, agreement negotiations and special projects in a timely manner as requested.

QUALITY/SAFETY ESSENTIAL FUNCTIONS

• Analyzes contracts submitted to the Houston Methodist Research Institute (HMRI) Office of Research Contracts.

• Ensures regulatory compliance by monitoring that safety committee approvals are in place; namely Institutional Review Board (IRB), and Institutional Animal Care and Use Committee approvals (IACUC).

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

• Ensures language related to publication, confidentiality, intellectual property, insurance indemnification and subject injury reimbursement are compliant with institutional guidelines and policies.

FINANCE ESSENTIAL FUNCTIONS

• Reviews and negotiates favorable payment terms in research agreements which include ensuring compliance with institutional policies and federal regulations, institutional overhead, and fee requirements and internal budgets for clinical trials.

GROWTH/INNOVATION ESSENTIAL FUNCTIONS

• Provides feedback on errors or issues with MORTI system.

• Seeks opportunities to expand learning beyond baseline competencies with a focus on continual development. Completes and updates the My Development Plan on an on-going basis.

SUPPLEMENTAL REQUIREMENTS

WORK ATTIRE

• Uniform: No

• Scrubs: No

• Business professional: Yes

• Other (department approved): No

ON-CALL *

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

• On Call* No

TRAVEL **

Travel specifications may vary by department

• May require travel within the Houston Metropolitan area Yes

• May require travel outside Houston Metropolitan area No

QUALIFICATIONS

EDUCATION

• Juris Doctor degree

EXPERIENCE

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

Company Profile:

Houston Methodist Academic Institute oversees the Education Institute and Research Institute. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care. Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports trainees in residence for medical, nursing, allied health and research education programs. Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports clinical research protocols and extramurally funded translational research programs.

Houston Methodist is an Equal Opportunity Employer.