Requisition ID: 32807
At Terumo Blood and Cell Technologies, our 7,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.
We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient's life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.
With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.
We are seeking a dedicated Clinical Research Associate (CRA) to manage clinical trial sites, ensuring strict adherence to regulatory guidelines, Clinical Investigation Plans, and broader clinical objectives. In this role, you'll be responsible for reviewing and analyzing clinical data, playing a key part in the success of trial outcomes. Ideal candidates will have a strong commitment to maintaining professional expertise through continual engagement with clinical literature. If you are a detail-oriented professional with a passion for advancing clinical research and ensuring compliance at every level, this is the opportunity for you!
ESSENTIAL DUTIES
- Conduct site feasibility, initiation, routine monitoring, and study closeout visits.
- Monitor, track, and manage all study related tasks at study sites ensuring compliance with GCP, ICH, applicable regulations and company SOPs.
- Collect, review, track, and ensure appropriate completion of site-specific study/essential documents. Performs ongoing reconciliation of the Trial Master File (TMF) content to site files.
- Primary contact for study site personnel.
- Provide training to site personnel.
- Track and report progress of study sites.
- Responsible for quality data from study sites. Ensures appropriate source documentation, training, and accurate transcription of data into the study Case Report Form (CRF) as evidenced by minimal data query rates. Ensures timely reconciliation of data queries and implementation of process improvement/corrective action when needed.
- Participate in team meetings.
- May take meeting minutes, develop and maintain study trackers, or assume other tasks to support study team.
- Coordinate, assemble, and ship study related supplies as needed.
- Assist with creation and review of study tools/documents.
- Maintains awareness of overall development in the field of clinical research based on current literature, attendance at professional meetings, continuing education, etc.
MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor's degree or equivalent education and experience sufficient to successfully perform the essential functions of the job may be considered.
Experience
Minimum 2 years experience.
Skills
- Self-directed with ability to work independently.
- Has a broad understanding of applicable related regulations and ICH GCP requirements.
- Positive and proactive approach to identification and definition of problems, and with the development and implementation of solutions.
- High level of adaptability, initiative, and willingness to take ownership and accept responsibility for actions and decisions.
- Attention to detail and the ability to prioritize. Strong organizational, planning and follow-through skills.
- Ability to work well under pressure and with tight schedules.
- Ability to exercise judgment within generally defined practices and policies for obtaining data.
- Self-direction and motivation are mandatory.
- Demonstrate diplomacy and tact while maintaining appropriate assertiveness and persistence.
- Knowledge and use of relevant PC software applications and skills to use them effectively.
- Demonstrated ability to communicate effectively both verbally and in writing.
-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.
LOCATION
Lakewood, Colorado - Open to remote
TRAVEL
Position may require approximately 50-75% overnight travel to required site visits.
PHYSICAL REQUIREMENTS
- Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
- The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Target Pay Range: $73,000.00 to $91,200.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.
Target Bonus on Base: 7.0%
At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.
Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
- In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
- We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
- We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
- Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
- Respect - Appreciative of others
- Integrity - Guided by our mission
- Care - Empathetic to patients
- Quality - Committed to excellence
- Creativity - Striving for innovation
- We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.
We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.
Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.
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