Senior Clinical Research Associate

Company: Horizon Therapeutics
Location: Buffalo Grove
Posted on: May 12, 2022

Job Description:

Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

Summary
This in-house, senior clinical research associate (CRA) position is responsible for assisting the Clinical Operations department with managing clinical trials, including onsite co-monitoring, as needed.

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) Assists in start-up activities of clinical studies including Investigator Meetings, selection of trial sites and investigators. Assist in managing CRO's/ FSPs under the direction of study managers. Attend co-monitoring visits as needed. Reviews monitoring visit reports from CRO/FSP. 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. Writes, reviews, and / or provides input to study plans and guidelines. 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 QC. Ensures the quality control of critical documents. 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 operations 3-5 years' experience performing in house study support or on-site monitoring conducting SIVs, IMVs, COVs and/or co-monitoring experience for IND regulated clinical research studies Thorough knowledge of ICH-GCP, Food and Drug Administration (FDA) and European regulations Demonstrated effectiveness in resolving site management issues of varying complexity Strong analytical skills Proficient in Microsoft Office Professional demeanor Self-starter attitude Strong interpersonal skills Excellent written and verbal communication skills Ability to travel - potential to be international -as required

Horizon Core Values & Competencies:

Growth
Manages Ambiguity Strategic Mindset Demonstrates Self-awareness Cultivates Innovation Develops Talent

Accountability
Drives Results Ensures Accountability Decision Quality

Transparency
Courage Collaboration Instills Trust

Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). "Fully vaccinated" is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law.

Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

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