Research Contract Specialist_

Burlington

**Job Type:** Regular

**Time Type:** Full time

**Work Shift:** Day (United States of America)

**FLSA Status:** Exempt

**When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives.**

Under general supervision of the Manager of the Office of Sponsored Research, the Contracts Specialist works with investigators, sponsors and contract research organizations, and collaborating institutions to negotiate research agreements in accordance with Lahey and BILH policies. The Contracts Specialist reviews and negotiates contract terms and conditions, develops and maintains standard agreement templates, and updates standard operating procedures as needed. The Contracts Specialist works closely with the BILH Office of General Council (OGC) to resolve any issues that may arise relating to sponsored research agreements. The Contracts Specialist is responsible for most of the administrative and legal processing of research-related contracts, subject to OGC oversight, as needed and according to established Institutional policies.

**Job Description:**

Essential Duties & Responsibilities including but not limited to:

+ Primarily responsible for drafting, revising and negotiating sponsored research agreements, clinical trial agreements, amendments, subcontracts, confidentiality agreements, service agreements, and master agreements on behalf of Lahey for human subject research.

+ Reviews and negotiates all contract agreement terms and conditions for adherence to Lahey, BILH and sponsor policies. Follows established guidelines with particular regard to provisions regarding publication rights, confidentiality, intellectual property rights, HIPAA, AAHRPP, indemnification and subject injury

+ Prepares agreement drafts, negotiates, executes and distributes fully executed agreements. Enters agreement status data into tracking system. Works with other Research Administration offices as a resource for input and information, as needed.

+ Works with the IRB Office to assure alignment of terms within both the informed consent form and the agreement

+ Provides prompt and regular status update of contract negotiations to principal investigators and administration. Meets or exceeds targeted turnaround times from receipt of original contract to executed agreement. Works with the OSR Manager to maintain a database of turnaround times, analyze workflow, and track and monitor turnaround time criteria and metrics

+ Collaborates with the Office of General Counsel to identify, define and resolve clinical research issues that may impact institutional guidelines and policies related to clinical research.

+ Understands and keeps current with FDA and Medicare regulations applicable to clinical trials. Implements rules, regulations, guidelines and state and federal laws regulating clinical trials

+ Collaborate with investigators, sponsors and attorneys to develop and negotiate budgets and payment terms for industry-sponsored clinical trials, investigator-initiated research projects, and grant applications.

+ Review research protocols, clinical practice guidelines, and National and Local Coverage Determinations to conduct prospective reimbursement analysis (or “Medicare Coverage Analysis”).

+ Maintain thorough understanding of state, federal, and commercial payer rules governing prior-authorization, reimbursement of routine costs in clinical trials, coding and claims processing requirements for billing research-related items and services.

Minimum Qualifications:

+ Bachelor's degree required. Master’s degree in health, law or scientific field preferred.

+ 3-5 years related work experience required

+ Requires a detailed knowledge of laws and regulations governing the conduct of research, in particular clinical research.

+ Requires proficiency with Microsoft and other web-based applications. Advanced skills with Microsoft Excel and Word are particularly important for this role.

Competencies:

+ Problem Solving: Ability to address problems that are broad, complex and abstract, often involving Institution-wide issues and requiring substantial creativity, resourcefulness, and staff engagement;

+ Independence of Action: Ability to prioritize work for multiple departments, and make good decisions with minimal oversight;

+ Written Communications: Ability to communicate complex information in English effectively in writing to all levels of staff, management and external customers across functional areas;

+ Oral Communications: Ability to verbally communicate complex concepts in English and address sensitive situations, resolve conflicts, negotiate, motivate and persuade others;

+ Knowledge: Ability to demonstrate broad and comprehensive knowledge of theories, concepts, practices and policies with the ability to use them in complex and/or unprecedented situations across multiple functional areas.

+ Team Work: Ability to lead collaborative teams for larger projects or groups both internal and external to the Institution and across functional areas.

+ Customer Service: Ability to lead operational initiatives to meet or exceed customer service standards and expectations in assigned unit(s) and/or across multiple areas in a timely and respectful manner.

**As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment. Learn more (ilh.org/newsroom/bilh-to-require-covid-19-influenza-vaccines-for-all-clinicians-staff-by-oct-31) about this requirement.**

**More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.**

**Equal Opportunity** **Employer/Veterans/Disabled**