Full Job Description
This position is responsible in consultation with the Clinical Trials Office (CTO) Manager for providing an independent review, negotiation and preparation for execution of the various contracts with industry sponsors for studies related to human subject research. Assess each contract 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 and AAHRPP requirements with respect to research.
Job Description:
Primary Responsibilities:
1. Advise the CTO Manager on contract status, and discuss any outstanding terms for the various research contracts. (essential)
2. Assess each contract for compliance with institutional, CRICO and Harvard policy, and applicable Federal and State Laws, in the areas of indemnification, subject injury, HIPAA, confidentiality, publication, funding terms, intellectual property rights, insurance, termination and AAHRPP requirements with respect to research. (essential)
3. Review, revise or draft terms and conditions in contracts where necessary to meet the requirements of the Institution for research agreements. (essential)
4. Maintain thorough and current knowledge of federal and state laws, rules and regulations concerned with academic research within a healthcare setting. (essential)
5. Represent client in often complex transactional matters including working in close collaboration with clients to understand the goals of the transaction, successfully negotiating documents and bringing the transaction to a successful conclusion. (essential)
6. Has the authority to direct and support employees daily work activities. Has authority to undertake or recommend the following employment actions: hiring, termination, corrective action and performance reviews. Direct Reports: None Indirect Reports: None
Required Qualifications:
1. Doctoral degree in Juris Doctorate required.
2. 5-8 years of related work experience required; 3 or more years in a healthcare setting preferred.
3. Admission to the Massachusetts Bar.
4. Advanced technical computer skills as required for technical support specific to functional area and related systems.
Pay Range:
$50.00 - $100.00
The pay range listed for this position is the base hourly wage range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. Compensation may exceed the base hourly rate depending on shift differentials, call pay, premium pay, overtime pay, and other additional pay practices, as applicable to the position and in accordance with the law.
