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

Job Type:

Regular

Scheduled Hours:

40

Work Shift:

Day (United States of America)

Under the general direction of the Associate Director of the Clinical Trials Office (CTO), the Senior Contracting Specialist works with investigators, clinical trial coordinators and industrial sponsors and contract research organizations to negotiate clinical research agreements in accordance with BIDMC' institutional policies. The Senior Contracting Specialist provides orientation, training and mentoring to CTO clinical research agreement associates, conducts and coordinates peer-review and quality assurance activities within CTO and facilitates interactions with CTO and the Technology Ventures Office (TVO) and the Office of Sponsored Programs (OSP) regarding issues and agreements that overlap with CTO expertise. Represents BIDMC to industry sponsors and is primarily responsible for reviewing and negotiating Clinical Trial Agreements, Clinical Research Support Agreements, Confidential Disclosure Agreements, Amendments, Subcontracts, Master Agreements and other Non-Funded Industry Agreements related to human subject research studies. Assesses each agreement for compliance with institutional policy, and applicable Federal and State Laws, in the areas of indemnification, subject injury, HIPAA, confidentiality, publication, funding terms, intellectual property rights, insurance, termination, arbitration, and AAHRPP requirements. Works closely with the Associate Director of the Clinical Trials Office, BIDMC General Counsel, members of the Office of Business Conduct and others to accomplish these responsibilities. Maintains institutional database regarding contracts and contractual issues and works with clinical trials financial analysts as needed to complete the work of the CTO.

Job Description:

Essential Responsibilities:

• Primarily responsible for drafting, revising and negotiating Industry-Sponsored Clinical Research Agreements, Amendments, Subcontracts, Confidentiality Agreements, Service Agreements, and Master Agreements on behalf of BIDMC for human subject research.

• Determines whether CTO and sponsoring company have negotiated a standard clinical trial agreement and whether it is applicable to the proposed clinical trial.

• Prepares agreements for submission to sponsor using standard CTO format for clinical research agreements. Negotiates with sponsor as necessary following established guidelines with particular regard to provisions regarding publication rights, confidentiality, intellectual property rights, HIPAA, AAHRPP, indemnification and subject injury.

• Determines the appropriate intellectual property provisions to include in agreements, in light of existing institutional commitments and likelihood that an invention will be made in the proposed work.

• Collaborates with the Office of General Counsel and Institutional Review Board (IRB) 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.

• Enters and maintains data in the medical center's clinical research database. Perform queries for PI's, industry sponsors and administration as requested. Tracks the status of each ongoing agreement negotiation using the departmental database.

• Liaises with the IRB as needed; handles IRB inquiries regarding coordination between the informed consent form and the agreement.

• Provides prompt and regular status update of contract negotiations to PI's and administration. Meets or exceeds targeted turnaround times from receipt of original contract to executed agreement. Works with the administrator in the Clinical Trials Office to maintain a database of turnaround times, analyze workflow, and track and monitor turnaround time criteria and metrics.

• Works with Office of Business Conduct and Research Compliance Officer to ensure that template language for standard BIDMC contract is in compliance with all Federal, State, and Institutional requirements. Identifies issues as needed for review by Office of Business Conduct and Research Compliance Officer.

Required Qualifications:

1. Bachelor's degree required; Doctoral degree preferred.

2. 1-3 years related work experience required in related work experience and experience in contract negotiation.

3. Strong organization and time management skills with ability to manage numerous projects simultaneously in a time sensitive environment required.

4. Ability to work independently with minimal supervision.

5. Excellent interpersonal and communication skills required.

6. Experience with computer systems required, including web-based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access.

Competencies:

Decision Making: Ability to make decisions that are guided by general instructions and practices requiring some interpretation. May make recommendations for solving problems of moderate complexity and importance.

Problem Solving: Ability to address problems that are varied, requiring analysis or interpretation of the situation using direct observation, knowledge and skills based on general precedents.

Independence of Action: Ability to follow precedents and procedures. May set priorities and organize work within general guidelines. Seeks assistance when confronted with difficult and/or unpredictable situations. Work progress is monitored by supervisor/manager.

Written Communications: Ability to summarize and communicate in English moderately complex information in varied written formats to internal and external customers.

Oral Communications: Ability to comprehend and communicate complex verbal information in English to medical center staff, patients, families and external customers.

Knowledge: Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.

Team Work: Ability to work collaboratively in small teams to improve the operations of immediate work group by offering ideas, identifying issues, and respecting team members.

Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Ability to remain calm in stressful situations.

Physical Nature of the Job:

Sedentary work: Exerting up to 10 pounds of force occasionally in carrying, lifting, pushing, pulling objects. Sitting most of the time, with walking and standing required only occasionally.

FLSA Status:

Exempt

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 (https://www.bilh.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