Senior Clinical Research Associate (Northwest) job Denver Colorado
Senior Clinical Research Associate (Northwest) job Denver Colorado
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Senior Clinical Research Associate (Northwest) Job



Employer Name: Ferring Pharmaceuticals SpiderID: 8715274
Location: Denver, Colorado Date Posted: 6/6/2019
Wage: Category: Science/Research
Job Code: R0010026

Job Description:
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Ferring is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. Ferring employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. Learn more at www.ferring.com and @Ferring, or connect with us on Facebook, Instagram and LinkedIn.


Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with approximately 6,500 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women’s health (obstetrics/gynecology), orthopedics and Oncology.  Ferring’s US operations employ approximately 900 people.
 
People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.
 
Rebiotix, a late-stage biotechnology company part of the Ferring Pharmaceutical Group, is focused on commercializing the world’s first Microbiota Restoration Therapy. By harnessing the power of the human microbiome, Rebiotix aspires to change the way challenging gastrointestinal diseases are treated. Our goal is to improve the lives of patients and reduce the cost of care associated with some of the most debilitating disorders suffered by patients worldwide. We are a passionate team of scientists, engineers and clinical researchers motivated by the opportunity to blaze new trails and create new technologies for today’s medical field, looking for like-minded individuals to add to our growing team.
 
Summary:    

The Senior Clinical Research Associate (Sr. CRA) performs trial-related activities in compliance with Standard Operating Procedures (SOPs), FDA regulations, ICH/GCP, applicable local laws and regulations and Rebiotix company policy. The Sr. CRA demonstrates an advanced level of training, qualifications, knowledge, experience and leadership. The Sr. CRA independently manages and conducts monitoring activities at clinical study sites to ensure protocol compliance, safety, and GCP for a protocol or clinical program under the direction of Clinical Management. 
 
This is a field-based position located on in the Northwest Region. Candidate must reside within the territory (Washington, Oregon, Utah, Idaho, Colorado).
 
Responsibilities:
 
Study site management
* Primary point of contact with assigned investigative sites.
* Conducts monitoring visits and completes monitoring reports.
* Conducts data review, query generation and resolution.
* Assists sites with audit preparedness.
* Assists with IRB submissions and tracking.
* Manages the development and implementation of site corrective actions as needed to address any compliance issues.

 
Site Identification and Activation
* Participates in the study site identification and qualification process.
* Leads study site initiation visits and trainings.
* Reviews and approves study site activation documentation.
* Ensures ongoing site training needs are met.

 
Vendor contact
* Collaborates with contracted vendors, including but not limited to:  Clinical research organization (CRO), central laboratory, Medical Monitor, etc.
* May manage relationship with contracted vendor, including scope of work and contract/budget initiation.

 
Development of monitoring tools and study-related documents
* Assists with the development and management of study-related documents and monitoring tools, including but not limited to:  Clinical protocols, case reports forms, monitoring plan, study manuals, and study-related tools for monitoring.
* Contributes to SOP development and review.


Job Requirements:
Requirements:
* Bachelor's degree in nursing, health sciences or related field.
* 5 or more years of CRA experience with at least two years of clinical site monitoring.
* Excellent verbal and written communication skills required. Interpersonal and organizational skills are a must.
* Ability to travel approximately 60% including ability to manage travel logistics; up to 80% travel during peak periods may be required.
* Well versed and current in GCP, ICH, FDA and other relevant regulations and guidances that govern clinical study conduct.

We are proud to be an Affirmative Action/EEO Employer.  EOE Minorities/Females/Protected Veterans/Disabled
 
We maintain a drug-free workplace and perform pre-employment substance abuse testing.


Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:


Contact Information:
Contact Name: Jaclyn Moore Company Type: Employer
Company:
City: Denver
State: Colorado
Zip:
Web Site: https://ars2.equest.com/?response_id=bf527cfa693e1a960313e31bd18a7129

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