Clinical Research Associate

Overview
At the heart of QIAGEN’s business is a vision to make improvements in life possible.

We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
Our most valuable asset are our employees – more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people’s lives, then QIAGEN is where you need to be.

Join us. At QIAGEN, you make a difference every day.

Position Description

The primary purpose of the CRA is to review the progress of a clinical performance study at clinical study sites, ensuring that it is conducted, recorded and reported in accordance with approved protocols, written procedures, International Council for Harmonisation (ICH) Good Clinical Practice (GCP) compliance, regulatory requirements and QIAGEN Standard Operating Procedures (SOPs). The CRA must also ensure the clinical study is performed such that the subjects’ rights, safety and well-being are protected and that the clinical study data are reliable. Position may be remote for qualified candidate. Responsibilities include but are not limited to:

Performing SIV / site training of study protocols, SOPs, Case Report Form completion, site records, database, data entry requirements, and testing workflow to ensure sites are competent in performing study procedures.
Conducting regular IMVs – on site and remote – to execute monitoring activities, including SDV, query resolution, Investigator Site File (ISF) review, product accountability, and writing monitoring visit reports based on requirements from protocol, monitoring plan, SOPs and GCP.
Identifying and escalating, in a timely manner to the Clinical Study Lead (CSL), any protocol deviation or other events that could potentially affect study results or on-time completion of study, and suggest means of resolving the issue(s) with CSL assistance as needed.
Coordinating with site and investigators to ensure effective execution of clinical study protocols, data traceability and correction if/when necessary while maintaining positive relationships with external sites and investigators.
Executing site close-out activities and archive all study records and data results at each site according to SOP and GCP requirements.
Liaising with the CSL for relevant projects and support Clinical Affairs function during audits e.g. BIMO, Pharma partner, FDA.
Business travel (up to 70%).

Position Requirements

2-3 years’ experience as CRA for IVD, MD or pharmaceutical clinical trials
Working knowledge of ICH GCP and ISO standards (20916 or 14155) and regulatory requirements for IVD’s
Experience of working within a regulated environment
Experience of audit situations
Experience coordinating with external study sites
IT literacy, particularly in Word, Excel and PowerPoint
Previous experience of working in Clinical Research or the Pharmaceutical Industry
Knowledge of the Industry/Clinical study process, drug development or medical devices.
Education in scientific or medical field; prior experience in clinical diagnostic or molecular biology research lab preferred.
Experience with diagnostic clinical trials;
CRA or CRC certification preferred.

Personal Requirements

Clear and kind communication skills – both written and verbal
Excellent attention to detail
Exceptional organizational skills
Ability to prioritize and multi-task
Quick learner and self-motivated
Pro-active and flexible
Willingness to go the extra mile if needed to deadlines
Work in a team and independently
Effective time management
Salary Range: $88,000 - $118,000

QIAGEN requires proof of full COVID-19 vaccination as a condition of employment for new hires in all U.S. states other than Montana effective as of September 1, 2021. New hires and candidates will be required to present proof of full COVID-19 vaccination within three business days of start date or upon entry into the office (i.e., for interviews), whichever comes first. QIAGEN complies with applicable laws regarding the confidentiality of employee health information and the reasonable accommodation of individuals with disabilities and/or sincerely held religious beliefs. Candidates who require accommodation should contact [email protected]. This policy is part of QIAGEN’s ongoing efforts to support public health efforts and to ensure the safety and-well-being of its employees, customers, business partners, and community.

What we offer

At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including but not limited to assumptions about a person’s appearance or behavior, gender roles, gender expression, or gender identity), gender, gender identity, gender expression, national origin, age, mental or physical disability, ancestry, medical condition, marital status, military or veteran status, citizenship status, sexual orientation, genetic information, or any other status protected by applicable law.

Please apply on our website under this link: https://www.qiagen.com/us/about-us/careers/jobs/d…