Sr. Clinical Research Associate

Responsibilities

• Perform Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and Close Out Visits
• Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) team to ensure efficient preparation and delivery of study materials to investigator sites
• Ensure investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug
• Aid in the development of study/program plans (i.e., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.)
• Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (e.g., study-site webinars, newsletters or other potential creative solutions)
• Maintain project files including ethics committee approvals, curricula vitae of investigators and study personnel, clinical investigators brochure, protocols, case report forms instructions, consent documents, clinical-trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, and all investigator and site correspondence
• Identify and complete follow-up of Serious Adverse Events (SAEs) at study sites
• Assist with data listing, data coding, patient profile reviews, database lock, and site close-out activities
• Ensure appropriate and timely submission of documents to the Trial Master File
• Perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verify the IP has been dispensed and administered to subjects/patients according to the protocol. Verify issues or risks associated with blinded or randomized information related to IP

Qualifications

• Bachelor’s degree in health science or related field
• 5+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits
• Excellent verbal and written communication skills
• Excellent organizational, multi-tasking and time management skills
• Demonstrated experience developing/maintaining site relationships and securing compliance
• Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF)
• Ability to travel as required (50-75%)

Pay

The expected base salary range for this position is $90,000 - $130,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.

Benefits

• 100% paid employee premiums for medical/dental/vision, also STD, LTD
• 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years
• 15 PTO days per year, sick leave, plus 11 paid holidays

About the Role

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.