Senior Clinical Research Associate (field based) at Ferring Pharmaceuticals Inc. in Minneapolis, Minnesota

Posted in Other 3 days ago.





Job Description:

Job Title:

Senior Clinical Research Associate (field based)

Job Description:

Rebiotix Inc, part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of debilitating diseases. Located in Roseville, Minnesota, our goal is to improve the lives of patients and reduce the cost of care associated with complex diseases through our innovative microbiota-based MRT drug platform. 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 needs. We are looking for like-minded get-it-done 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 role is field based and the territory will be located in the Central or EasternUS.

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.

Any other duties as assigned for business reasons.

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.

If you need assistance during the application process due to a disability, please email careers@ferring.com

Location:

Minnesota