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

• 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