Celerion

Clinical Research Coordinator

Posted Yesterday

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Lincoln, NE, USA

In-Office

Entry level

Pharmaceutical

The Role

Manage and conduct clinical bioequivalence/bioavailability studies, ensure compliance and quality, coordinate with support teams, organize study logistics and meetings, interact with clients, and maintain study profitability and timelines. May work evenings and weekends.

Summary Generated by Built In

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

We are seeking a Clinical Research Coordinator to join our Lincoln, NE team! This is a great opportunity for someone seeking a career change. Training is provided.

As a Clinical Research Coordinator you are responsible for oversight and conduct of clinical studies. You will ensure compliance, quality, and profitability of clinical studies. You respond to internal and external client issues, concerns, and requests by applying study management techniques and tools. In this role you should plan to work some evening and weekends.

Primary Responsibilities:

You are responsible for the overall management of Clinical Studies to include: on-time performance with defect-free execution, independently conducting bioequivalency and bioavailability studies, working with support divisions to ensure timelines are being met in clinical studies (i.e. recruiting, data management, statistics), organizing study initiation meetings to plan execution of study, facilitating study review meetings for pre-study, in-process and post study review, problem solving as needed during study conduct, meeting with clients as needed throughout study, and organizing study logistics and personnel. In addition, you will be present at critical events and dosings of study. You will build client relationships that result in additional business, you will craft and edit reports, respond to client issues, concerns and requests, adhere to milestone guidelines, and ensure profitability by maintaining profitability of team through a budgeting and expense control on a total and individual study basis.

Requirements

You will have a Bachelor’s degree in a related discipline or BSN required. Celerion experience may be considered in lieu of degree in some situations.
Industry experience and knowledge of medical terminology preferred.
Demonstrated organizational, time management and multi-tasking skills required
Shown ability to handle multiple priorities
Excellent oral and written communication skills
You will work without close supervision
Ability to work flexible hours required for study conduct
You will utilize customer service skills
Clinical Research experience useful, but not required

Celerion Values: Integrity Trust Teamwork Respect

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

Skills Required

Bachelor's degree in a related discipline or BSN
Celerion experience may be considered in lieu of degree
Demonstrated organizational, time management, and multi-tasking skills
Ability to handle multiple priorities
Excellent oral and written communication skills
Ability to work without close supervision
Ability to work flexible hours, including evenings and weekends
Customer service skills
Industry experience and knowledge of medical terminology
Clinical research or experience conducting bioequivalence/bioavailability studies

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The Company

HQ: Lincoln, NE

1,029 Employees

Year Founded: 2010

What We Do

Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines. With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. Our operations are strategically located in: Lincoln, Nebraska (Corporate Headquarters) Philadelphia, Pennsylvania Phoenix, Arizona Belfast, Northern Ireland,UK Zurich, Switzerland Vienna, Austria Richmond, Virginia Montreal, Quebec, Canada For more information, visit: www.celerion.com