Clinical Contract Associate

Systimmune•Princeton, NJ

51d

About The Position

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.

Requirements

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

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