Sr Clinical Research Associate

Company: Horizon Therapeutics
Location: Buffalo Grove
Posted on: March 20, 2023

Job Description:

Job Description:

At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved. Our global biotechnology company is made up of agile, out-of-the-box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases. This is the heart of our global mission. Start a career that enables you to live up to your potential and help others live up to theirs. Join us. The exceptional support we provide patients and communities equally extends to our employees. We offer industry-leading and award-winning benefits, compensation and rewards programs that positively impact all areas of our employees' personal and professional lives. Position Summary: This position as Senior Clinical Research Associate (CRA) is a highly visible study team role, working closely with the Operations Manager and supporting project management activities. The Sr. CRA will support the Clinical Operations philosophy of a high-touch organization with our study teams and contract research organizations. The Sr. CRA is key member of the Clinical Operations department, working alongside their assigned team to assist in managing Phase 1 - 4 global clinical trials.Responsibilities:Participates in the development, execution, completion, and reporting of clinical trial(s) according to the regulations, on time and within budget.Assists in drafting study related documents (protocol, informed consents, study plans, etc.)Writes, reviews, and / or provides input to study plans and guidelines.Assists in start-up activities of clinical trials including Investigator Meetings, selection of trial sites and investigators.Assists in managing CROs / Functional Service Providers (FSP) under the direction of study managers.Attends co-monitoring visits as needed.Conducts Co-monitoring visitsReviews monitoring visit reports, escalates issues and works directly with CRO and secondary vendors to ensure appropriate follow-up and resolution of findings. Oversee CRO's vendors and identifies issues and risks, escalates items as necessary, and works directly with CRO / vendors to ensure appropriate follow-up and resolution of findings.Ensures the management and tracking to timely resolution of deficiencies identified via monitoring, auditing, project calls and updates or other sources.Understands and works to a risk-based approach, prioritizing the safety and welfare of human trial participants.Manages trial related materials and vendors, e.g. investigational product supplies, ancillary supplies, central laboratories, central IRB, etc. as assigned.Assists with the electronic trial master file (eTMF) processes including set-up and quality checks.Ensures the quality control of critical documents.Assist with CTMS updates for assigned trials.Collaborates with CRO/FSP counterpart on an ongoing basis.Performs monitoring (PSV, SIV, IMV, COV), as needed, of clinical trial(s) in accordance with company (or other applicable) SOPs, ICH E6 GCP, and other regulations and guidance as relevant.Qualifications and Skills Required:BS/BA degree in related field, preferably with a scientific background and 4+ years' experience in clinical development and operationsPrefer at least 2 years' experience performing on-site monitoring conducting SIVs, IMVs, COVs and/or co-monitoring experience for IND regulated clinical research studiesPrefer previous sponsor and vendor oversight management experienceThorough knowledge of ICH-GCP, Food and Drug Administration (FDA) and European regulations and other country regulations, as necessaryDemonstrated effectiveness in resolving site management issues of varying complexityStrong analytical skillsProficient in Microsoft Office.Professional, proactive demeanor.Strong interpersonal skills.Excellent written and verbal communication skills.Our ValuesTransparency: We value collaboration. Trusting teach other and tackling tough challenges can make a powerful difference.Accountability: We do what's right for our patient communities through quality decisions and owning our successes and failures.Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients.These three values come to life through our five Leadership Expectations that apply to all Horizon employeesEnterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspectiveExhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sourcesEnsure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitmentsEmbrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of workingDevelop Talent: Provide feedback, coaching and mentorship to help others be more effective in their roleCompensation and Benefits Summary:The salary range for this role is $117,000.00-$143,000.00 annually. The base salary offered may vary based on the final candidate's qualifications. The level of this role may also change based on the final candidate's qualifications.In addition to the salary, this position is eligible for the benefits listed here and for the following plans:Salary Plan, Annual Merit Plan, Annual Equity Grant, New Hire Equity Grant, Corporate BonusAt Horizon, we know that disease does not discriminate. We embrace the bold ideas of one another, foster a sense of belonging, and value inclusion. We attract and develop diverse talent because we believe that when people from different backgrounds and life experiences come together, we make lives better. Horizon intends that all qualified applications are given equal opportunity, and that selection decisions be based on job-related factors. We do not discriminate based on race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristics protected by law.

Keywords: Horizon Therapeutics, Buffalo Grove , Sr Clinical Research Associate, Healthcare , Buffalo Grove, Illinois