Clinical Contract Associate

For assigned studies, the Contract Associate is responsible for completing site contract and budget negotiations with sites participating in SystImmune clinical trials. This is included but not limited to Sites’ proposed changes to standard contract terms and the study-specific budget parameters (in partnership with other business lines internally), (3) ensuring the delivery of high quality, compliant, effective, and timely site contracts, and (4) maintaining productive relationships with internal stakeholders and sites.

Key Responsibilities

•  Accountable for negotiating clinical contracts within timelines with sites and Principal Investigators and site study staff
• Address changes to study scope to ensure timely contract amendments during the duration of Clinical Trials
• Negotiate Site facing budgets within approved parameters
• As a member of cross-functional study team, present on agenda topics related to contract and budget status of the SSU meetings as related to clinical contracting
• Single point of contact for internal stakeholders, and CROs, when applicable, and sites for assigned studies in North America
• Accountable for ensuring that performance and efficiency standards are met for assigned studies
• Assist with filing SystImmune’s site contracts in the company repository as instructed
• Engage with the study teams from SSU and feasibility processes throughout the end-to-end contracting lifecycle
• Work closely with internal stakeholders, and CROs and effectively communicate, in order to ensure that business objectives are met (e.g., scheduled site initiation visit deadlines)
• Handle site contracting related escalations from the CROs and/or the investigator sites, effectively and efficiently
• Develop and enhance relationships with internal stakeholders, CROs, and sites
• Ensure that internal systems are updated in a timely, accurate, and complete manner
• Meet with study teams regularly and prioritize assignments
• Execute changes related to study protocol amendments, ensuring timely contract amendment and implementation

• Required minimum of 2 years of relevant experience with clinical site contracting at a biopharmaceutical company, Clinical Research Site or CRO
• Strong negotiation skills
• Strong verbal and written communication in English
• Ability to work in a fast-paced working environment
• Bachelor’s Degree in scientific discipline, law, finance or related field

This job description has been designed to capture the essential functions of this job. It was not designed to contain or be interpreted as a comprehensive inventory of all the duties, responsibilities and qualifications required to perform this job. It is based on management’s assessment of the requirements and functions of the job as of the date this description was prepared.