Clinical Research Associate

EntryOncology
$60K - $90K/yr(estimated)

Description

<span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">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.<br>&#160;<br><span style="line-height:115%;"><span style="line-height:115%;">We are seeking a motivated <b>Clinical Research Associate (CRA)</b> to join our growing team supporting innovative early-phase oncology clinical trials (primarily Phase I). The CRA will assist in site monitoring activities and work closely with senior team members to ensure trial conduct is aligned with ICH-GCP, protocols, and regulatory requirements.</span></span><br><br><span style="line-height:115%;"><span style="line-height:115%;">This is an excellent opportunity for someone with CRA experience who is ready to take on broader site management responsibilities while being mentored by senior CRAs and clinical project managers.</span></span><br><br><strong>Responsibilities</strong></span></span><ul><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><span style="line-height:115%;">Assist with site qualification, initiation, routine monitoring, and closeout visits Monitor patient safety, protocol adherence, and data integrity during on-site and remote visits.</span></span></span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><span style="line-height:115%;">Perform source data review (SDR) and source data verification (SDV), ensuring timely resolution of data queries.</span></span></span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><span style="line-height:115%;">Ensure investigator sites maintain compliance with GCP, protocol, and SOPs, and support inspection readiness efforts.</span></span></span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><span style="line-height:115%;">Collaborate on the review and tracking of essential documents (e.g., ICFs, regulatory binders).</span></span></span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><span style="line-height:115%;">Support cohort management activities (e.g., dose escalation, enrollment tracking) as assigned.</span></span></span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><span style="line-height:115%;">Assist in documentation for Trial Master File (TMF) and site files to ensure completeness and accuracy.</span></span></span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><span style="line-height:115%;">Provide site training and support for EDC and trial systems Contribute to patient recruitment and retention initiatives at the site level.</span></span></span></span></li></ul><br><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><strong>Qualifications</strong></span></span><ul><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><span style="line-height:115%;">Bachelor&#8217;s degree in health sciences or related field.</span></span></span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><span style="line-height:115%;">1-5 years of total clinical trial experience (e.g., as CRA, CTA, in-house CRA, or CRC).</span></span></span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><span style="line-height:115%;">Exposure to oncology trials.</span></span></span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><span style="line-height:115%;">Knowledge of ICH-GCP guidelines and regulatory requirements.</span></span></span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><span style="line-height:115%;">Strong organizational skills, attention to detail, and ability to work both independently and within a team.</span></span></span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><span style="line-height:115%;">Willingness to travel regionally (approx. 50%-75%).</span></span></span></span></li></ul><br><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><strong><span style="line-height:normal;">Preferred</span></strong></span></span><ul><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><span style="line-height:115%;">1&#8211;5 years of experience in a CRA role, or at least 1 year in CRA role with 1-5 years in-house CRA, or Clinical Trial Assistant role.</span></span></span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><span style="line-height:115%;">Someone who has <b>supported Phase I or oncology studies</b> or is eager to grow into that space with guidance.</span></span></span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><span style="line-height:115%;">Strong foundational knowledge of GCP and site management but still gaining independence in full-site oversight.</span></span></span></span></li></ul><span style="font-size:14pt;"><span style="font-family:Arial;">&#160;</span></span><br><span style="font-size:11pt;"><span style="font-family:Arial;"><span style="font-weight:bold;">Compensation and Benefits:</span></span></span><br><span style="font-size:11pt;"><span style="font-family:Arial;">The expected base salary range for this position is $60,000 - $90,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate&#8217;s qualifications, experience, and skills.</span></span><br><span style="font-size:11pt;"><span style="font-family:Arial;">While most offers typically fall within the <span style="font-weight:bold;">low to mid-point</span> of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise align strongly with the requirements of the role.</span></span><br><span style="font-size:11pt;"><span style="font-family:Arial;">&#160;</span></span><br><br><span style="font-size:11pt;"><span style="font-family:Arial;"><span style="font-weight:bold;">SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company&#8217;s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 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 and MORE.</span></span></span><br><span style="font-size:11pt;"><span style="font-family:Arial;">&#160;</span></span><br><span style="font-size:11pt;"><span style="font-family:Arial;"><span style="font-weight:bold;">We offer an opportunity for you to learn and grow while making significant contributions to the company&#8217;s success. </span></span></span><br><span style="font-size:11pt;"><span style="font-family:Arial;">&#160;</span></span><br><span style="font-size:11pt;"><span style="font-family:Arial;"><span style="font-weight:bold;">SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.</span></span></span><br>&#160;
SystImmune

SystImmune

BIOTECHNOLOGY

Novel therapeutic bi-specific, and multi-specific antibodies, antibody-drug conjugates

LocationWA - Redmond
Open Jobs47
OncologyNeurology
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