SENIOR CLINICAL RESEARCH ASSOCIATE

Advanced Clinical is seeking an experienced working through an FSP model in a mid-sized pharmaceutical company in complex therapy for rare diseases. Do you have the passion and commitment to join a group whose mission is to develop treatments that clearly and profoundly impact patients suffering from rare diseases? Does it excite you to be a part of a patient-focused company developing potential new treatments that could dramatically improve patients' lives with limited to no current treatment options? If yes, we encourage you to share your aspirations and career goals with us. The Client is focused on restoring healthy immune system function by developing novel therapeutics to treat chronic neutropenic disorders, including WHIM syndrome, a rare primary immunodeficiency. We are advancing a novel, late-stage clinical candidate that we believe has the potential to become a new standard of care for patients with these disorders. We know that developing innovative, new medicines is challenging, and we invite new colleagues who share our values and commitment to join us in achieving our mission. This opportunity will …Align with your values and grit, and passion for innovative science. Leverage your knowledge of Clinical Operations to support our innovative science and allow you to have a major impact on our mission to support our patients. Offer a collegial environment with a team-based approach, where our mission drives our values, behaviours, and creativity. Accountabilities and Responsibilities: This is a crucial internal and external role responsible for collaborating with various stakeholders, supporting the quality delivery, and overseeing Client clinical trials. Collaborate with clinical trial sites and third-party vendors to ensure adherence to protocol(s) and study requirements; may include monitoring and co-monitoring responsibilities documents for completeness, accuracy, and compliance with protocol and appropriate regulations; Identify issues and take appropriate corrective actions.Support sites in strategy for identification and screening of potential study participants, maintenance of appropriate documents for conduct of study at the site, and follow through on issuesContribute to creating and reviewing study-specific plans, specification documents, materials, and tools. Assist in preparing study-related documents (i.e., ICF, clinical trial tools, templates, training materials, manuals, study newsletters, etc.).Delivered and executed operational tasks and assisted in tracking study metrics, maintenance, and distribution of study trackers.QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs, and timelines. Requirements: Proven Experience, Skills, and Education:Bachelor’s degree requiredMinimum of 2-5 years of experience in the biotech or pharmaceutical industry, with at least 2+ years direct experience as a Clinical Research Associate/Monitor Working knowledge of ICH GCP regulations and clinical protocols.Sound analytical and problem-solving skills; ability to act with a sense of urgency.Demonstrated effectiveness in resolving complex site management issues.Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines.Ability to work in a fast-paced environment with demonstrated agility to juggle multiple competing tasks and demands.Excellent written and verbal communication skills.Team player that takes initiative and is willing to support optimizing the way we work.Travel required and could be 50+%. About Advanced ClinicalAdvanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience, and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.Regarding your applicationPlease keep in mind that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we appreciate your effort by carefully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.Equal Employment OpportunityIt is Advanced Clinical’s practice not to discriminate against any employee or applicant because of sex, race, colour, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.508179