Clinical Study Start-Up Associate

<div class="content-intro"><p>When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we’re driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we’re doing this with extraordinary science and awesome people (affectionately called Rapptors).&nbsp;</p> <p>Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials in primary generalized tonic-clonic seizures (PGTCS) and bipolar disorder.</p> <p>The strength of Rapport comes from our Rapptors – who are united by our mission to improve patients lives. We bring the heart and hustle to advance our science forward, always staying true to our core values. We hope you’re as excited about this opportunity as we are!</p></div><p>&nbsp;</p> <p><span style="font-size: 12pt;"><em>This role is based in Boston, MA and is required to be onsite Monday-Wednesday each week!</em></span></p> <p><span style="font-size: 12pt;"><strong><span style="color: rgb(45, 194, 107);"><span style="color: rgb(22, 145, 121);">Your impact:</span></span></strong></span></p> <p><span style="font-size: 12pt;">Join our Clinical Operations team and play a key role in getting clinical studies off the ground. As a Study Start-Up Associate, you'll help drive study activation by coordinating essential start-up activities, managing critical documentation, and partnering with cross-functional teams to keep studies on track. If you're highly organized, thrive in a fast-paced environment, and enjoy bringing structure to complex projects, this is a great opportunity to make an impact from day one.</span></p> <p><span style="font-size: 12pt;"><strong><span style="color: rgb(45, 194, 107);"><span style="color: rgb(22, 145, 121);">Your day-to-day:</span></span></strong></span></p> <ul> <li style="font-size: 12pt;" data-section-id="106i477" data-start="704" data-end="791"><span style="font-size: 12pt;">Support study start-up activities from protocol finalization through site activation.</span></li> <li style="font-size: 12pt;" data-section-id="svaafq" data-start="792" data-end="941"><span style="font-size: 12pt;">Coordinate, review, track, and maintain essential study documents (e.g., protocols, ICFs, IBs, regulatory documents, and site activation packages).</span></li> <li style="font-size: 12pt;" data-section-id="md3a3x" data-start="942" data-end="1069"><span style="font-size: 12pt;">Perform quality checks of study documentation and maintain inspection-ready TMFs in compliance with ICH-GCP and company SOPs.</span></li> <li style="font-size: 12pt;" data-section-id="a627s1" data-start="1070" data-end="1184"><span style="font-size: 12pt;">Track study start-up milestones, including regulatory submissions, IRB/EC approvals, and site activation status.</span></li> <li style="font-size: 12pt;" data-section-id="1tg4b3n" data-start="1185" data-end="1319"><span style="font-size: 12pt;">Partner with Clinical Operations, Regulatory, CROs, and vendors to drive timely study start-up and resolve outstanding action items.</span></li> <li style="font-size: 12pt;" data-section-id="1t76wex" data-start="1320" data-end="1402"><span style="font-size: 12pt;">Prepare and maintain study trackers, templates, and other operational documents.</span></li> <li style="font-size: 12pt;" data-section-id="jc9gky" data-start="1403" data-end="1483"><span style="font-size: 12pt;">Support vendor contract administration, purchase orders, and invoice tracking.</span></li> <li style="font-size: 12pt;" data-section-id="13gxfiy" data-start="1484" data-end="1567"><span style="font-size: 12pt;">Coordinate study meetings, document meeting minutes, and track follow-up actions.</span></li> <li style="font-size: 12pt;" data-section-id="1iwtl48" data-start="1568" data-end="1675"><span style="font-size: 12pt;">Assist with clinical trial registrations, insurance documentation, and other study start-up requirements.</span></li> <li style="font-size: 12pt;" data-section-id="2bm8my" data-start="1676" data-end="1767"><span style="font-size: 12pt;">Provide operational and administrative support to the Clinical Operations team as needed.</span></li> </ul> <p><span style="font-size: 12pt;"><span style="color: rgb(22, 145, 121);"><strong>Must-Haves:</strong></span></span></p> <ul> <li style="font-size: 12pt;" data-section-id="1qgqxyc" data-start="161" data-end="230"><span style="font-size: 12pt;">Bachelor's degree in Life Sciences, Healthcare, or a related field.</span></li> <li style="font-size: 12pt;" data-section-id="ff6054" data-start="231" data-end="377"><span style="font-size: 12pt;">3+ years of experience supporting clinical trials in a biotech, pharmaceutical, or CRO environment, with experience in study start-up required&nbsp;</span></li> <li style="font-size: 12pt;" data-section-id="10j33r6" data-start="378" data-end="528"><span style="font-size: 12pt;">Experience supporting global, multi-center clinical trials, including site start-up and activation activities across multiple countries and regions.</span></li> <li style="font-size: 12pt;" data-section-id="1ub0ev0" data-start="529" data-end="611"><span style="font-size: 12pt;">Working knowledge of ICH-GCP guidelines and the clinical trial start-up process.</span></li> <li style="font-size: 12pt;" data-section-id="gwgm7z" data-start="612" data-end="718"><span style="font-size: 12pt;">Experience reviewing, tracking, and maintaining essential study documents and Trial Master Files (TMFs).</span></li> <li style="font-size: 12pt;" data-section-id="rkds87" data-start="719" data-end="782"><span style="font-size: 12pt;">Familiarity with CTMS, eTMF, and document management systems.</span></li> <li style="font-size: 12pt;" data-section-id="1lyy7fc" data-start="783" data-end="936"><span style="font-size: 12pt;">Strong organizational and project coordination skills with the ability to manage multiple studies and competing priorities in a fast-paced environment.</span></li> <li style="font-size: 12pt;" data-section-id="1xa0v34" data-start="937" data-end="1024"><span style="font-size: 12pt;">Excellent attention to detail and ability to identify and resolve documentation gaps.</span></li> <li style="font-size: 12pt;" data-section-id="nl73bl" data-start="1025" data-end="1171"><span style="font-size: 12pt;">Strong written and verbal communication skills with the ability to collaborate effectively across cross-functional teams, CROs, and study sites.</span></li> <li style="font-size: 12pt;" data-section-id="1pwhi1j" data-start="1172" data-end="1251"><span style="font-size: 12pt;">Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, and Outlook).</span></li> <li style="font-size: 12pt;" data-section-id="tsoo65" data-start="1252" data-end="1367"><span style="font-size: 12pt;">Self-motivated, proactive, and able to work independently while contributing to a collaborative team environment.</span></li> <li style="font-size: 12pt;" data-section-id="pr2w44" data-start="1368" data-end="1479"><span style="font-size: 12pt;">Ability to maintain confidentiality and exercise sound judgment when handling sensitive clinical information.</span></li> </ul> <p><span style="font-size: 12pt;"><span style="color: rgb(22, 145, 121);"><strong>What makes Rapport special:</strong></span></span></p> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Your perspective matters. Stick your neck out, share your ideas – we work as a team.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Leadership that CARES – about you, your growth + development.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">You get to be YOU! Show up as you are and make every day count.</span></li> </ul> <p><span style="font-size: 12pt;"><span style="color: #169179;"><strong>Your impact:</strong></span></span></p> <p><span style="font-size: 12pt;">We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?&nbsp; We tell you about our hiring range now - we expect the hiring range for this role to be $90,000-$110,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company.&nbsp;</span></p> <p><span style="font-size: 12pt; color: rgb(45, 194, 107);"><strong><span style="color: rgb(22, 145, 121);">Hybrid work environment:&nbsp;</span></strong></span></p> <p><span style="font-size: 12pt;">This role is onsite in our Boston office. We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.</span></p> <p>&nbsp;</p><div class="content-conclusion"><p class="MsoNormal"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.</span></p> <p class="MsoNormal"><strong><span style="font-size: 10.0pt; line-height: 107%; font-family: 'Arial',sans-serif;">Note to Employment Agencies:</span></strong><span style="font-size: 10.0pt; line-height: 107%; font-family: 'Arial',sans-serif;"> Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.</span></p> <p class="MsoNormal"><span style="font-size: 10.0pt; line-height: 107%; font-family: 'Arial',sans-serif;">CCPA disclosure notice can be found <a href="https://www.rapportrx.com/privacy-policy/" target="_blank">here</a>.&nbsp;</span></p></div>