Clinical Research Contracts Associate II

SHIFT:

Seeking Breakthrough Makers

Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.

At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career.

CHOP does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means.

A Brief Overview
This role is responsible for the advanced preparation, drafting and negotiation of clinical research contracts and agreements.

This role also will maintain agreement databases, ensure compliance with regulations, help resolve contractual issues within agreements, and assist with the development and implementation of policies and procedures.

What you will do

• This position will, according to policies and procedures, draft, negotiate, and prepare for timely execution: Clinical Trial Agreements, Investigator-Initiated Clinical Trial Agreements, Clinical Trial Amendments, Clinical Trial sub-contracts, emergency IND contracts, and related agreements.
• This position will:
• Participate in the drafting, preparation, and negotiation of agreements
• Maintain the departmental agreement database(s)
• Ensure compliance with governmental and industry regulations
• Collaborate with stakeholders and colleagues to resolve contractual issues arising from agreements
• Assist with the development and implementation of institutional policies and procedures related to clinical research agreements.
• This position will also:
• Collaborate with team members, individual investigators and personnel within the Hospital in the preparation and submission of agreements
• Collaborate with management, internal Hospital / department personnel, and legal staff to ensure agreements internal compliance, and consistency between informed consent documents and agreements
• Identify any problematic language that may require negotiation and/or input from other CHOP offices (such as Offices of Technology Transfer, Risk Management, and General Counsel); and appropriately escalate stalled contract negotiations
• Maintain active communication with all stakeholders including investigators, research personnel, management, and external collaborators
• Function as departmental liaison with internal Hospital staff and external corporate research sponsors
• Participate in process improvement initiatives to provide internal customer service
• Generate reports to measure / manage workflow efficiently and effectively
• Provide documentation and reports to accounting, research and other departments for post award management and as requested
• Develop and conduct contract orientations, workshops, and presentations
• Enhance knowledge of agreements' academic standards, research best practices, and negotiations policies through ongoing personal development

Education Qualifications

• Bachelor's Degree - Required
• Juris Doctor (JD) Paralegal Studies - Preferred

Experience Qualifications

• At least three (3) years of contracting experience - Required
• At least five (5) years of clinical research contracting experience - Preferred
• Previous paralegal training experience - Preferred
• Previous clinical research experience - Preferred

Skills and Abilities

• Advanced proficiency with office software (Microsoft Office) including word processing, spreadsheet, and presentation software (Word, Excel, PowerPoint)
• Advanced proficiency with databases and information management systems
• Excellent verbal and written communications skills
• Excellent interpersonal skills
• Excellent time management skills
• Excellent organizational skills
• Ability to maintain confidentiality and professionalism

To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more.

EEO / VEVRAA Federal Contractor | Tobacco Statement

SALARY RANGE:

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.

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At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.