Clinical Research Associate jobs in Minnesota
Recently Added Clinical Research Associate jobs
Clinical Research Associate II
- Miromatrix Medical Inc.
-
Prairie, MN
FULL_TIME
- The job details are as follows: Clinical Research Associate II What We Do We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization. Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases. With over 100,000 patients on the organ transplant waitlist and only a fraction receiving the lifesaving organ they require, there is a great need for additional sources of transplantable organs. At Miromatrix, a leader in regenerative medicine and a subsidiary of United Therapeutics Corporation, we are working to address this unmet need by bioengineering human organs to help save and improve patients’ lives. Join our team as we continue to make history by developing life-saving therapies to help patients with liver and kidney disease. How you’ll contribute The Clinical Research Associate II collaborates with the Clinical Affairs team and cross-functional project team to ensure that clinical trials are conducted efficiently and effectively. The role involves both on-site and in-house monitoring activities to oversee the clinical trial, facilitate study enrollment, build effective relationships with study sites, protect the rights and well-being of study subjects, ensure accurate and complete reporting of trial data from source documents, and ensure that the study is conducted in compliance with the approved protocol, study specific plans, Clinical Affairs Standard Operating Procedures (CA-SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements. Essential Job Duties & Responsibilities Trial Support Activities: • Assist with the development and management of study-related documents including clinical protocols, case report forms, monitoring plans, study manuals, and other study-related tools • Lead or participate in the site qualification, activation, and initiation process, including review of site activation documentation • Assist in the planning of, preparing materials for, and presenting at investigator and coordinator meetings • Assist with study protocol training for investigators and coordinators • Establish and maintain regular contact with investigative site personnel • Track and report the progress of clinical studies, such as subject screening and enrollment, data collection, and adverse event documentation • Coordinate, schedule, and conduct monitoring visits at investigational sites to ensure compliance with the clinical protocol, regulations, and timely receipt of data including source document verification, writing monitoring reports and follow-up letters, and device accountability • Collect data trends from clinical trial site visit reports as requested by the study management team • Assist in data management with query generation and resolution and reporting of adverse events • Gather study data to report on trends, such as protocol deviation, adverse events, and missing data • Assist with the development and implementation of site corrective actions as needed to address any compliance issues • Assist the clinical management by providing input to, and conducting reviews of sections of the protocol, clinical reports, regulatory submissions, study summary reports, and abstracts/manuscripts/presentations • Assist with clinical research vendor management • Contribute to ongoing Standard Operating Procedure (SOP) development and review • Assist sites in audit preparedness • Coordinate, schedule, and conduct site close-out visits at investigational sites, including educating sites regarding record retention requirements Meeting Attendance and Discussions: • Actively participate in Clinical Monitoring department team meetings • Attend Investigator and Study Coordinator Meetings (in person or virtually) • Engage in cross-functional team discussions to provide updates on current study activities and ensure achievement of study milestones Corporate, Therapeutic and Industry Training: • Mentor junior CRA staff to develop best practices and ensure efficient/effective activities across studies • May sign off on CRAs’ capability to independently perform Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs) For this role you will need Minimum Requirements Bachelor’s Degree - preferably in health or biological sciences or Registered Nurse (RN) nursing qualifications or relevant clinical research experience in pharmaceutical/biotech/medical device or CRO industry may be considered 5 years of experience working in Clinical Research with progressive experience working in clinical trials 2 years of experience working as a Clinical Research Associate Working knowledge and understanding of the clinical trial process; including ICH-GCP, FDA regulations and familiarity with global regulatory bodies Demonstrated ability to work in clinical trial electronic systems including eTMF, EDC, and CTMS Attention to detail and accuracy of work Excellent interpersonal and customer service skills Ability to handle high workloads, stressful situations and meet deadlines Ability to work independently and as part of a cross-functional team Ability to multi-task in a demanding and rapidly changing environment Ability to work a flexible work week; inclusive of evenings and/or weekends At United Therapeutics you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients. While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients. United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success. We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.
- 4 Days Ago
Clinical Research Associate II
- Miromatrix Medical Inc.
-
Prairie, MN
FULL_TIME
- The job details are as follows: Clinical Research Associate II What We Do We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages ...
- 4 Days Ago
Clinical Research Associate
- Inspire Medical Systems, Inc.
-
Golden Valley, MN
FULL_TIME
- ABOUT INSPIRE MEDICAL SYSTEMS Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the ...
- 23 Days Ago
Senior Clinical Research Associate
- Danaher
-
Chaska, MN
FULL_TIME
- At first glance, you will see that for more than 80 years we have been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, ...
- 29 Days Ago
Clinical Research Assistant I
- Center for Veterans Research and Education
-
Minneapolis, MN
FULL_TIME
- Summary:The Center for Veterans Research and Education (CVRE), whose mission is helping to support innovative researchand education initiatives that improve the health and well-being of Veterans, is s...
- 10 Days Ago
Senior Clinical Research Associate (Contractor)
- PSI CRO
-
Santiago, MN
CONTRACTOR
- Company DescriptionWe are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together ...
- 1 Month Ago
Clinical Research Associate jobs at Popular Companies
Clinical Research Associate
- Tigermed America
-
Denver, CO
- Job Description Job Description An opening has become available for a SCRA or CRA to join one of the fastest growing CRO...
- 4/23/2024 12:00:00 AM
Clinical Research Associate
- Abbott
-
South Portland, ME
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-chan...
- 4/23/2024 12:00:00 AM
Clinical Research Associate
- McInnis Inc.
-
Ridgefield, CT
- The Clinical Research Associate will support clinical research activities within research sites that are actively partic...
- 4/23/2024 12:00:00 AM
Clinical Research Associate
- G&H Staffing Companies (Temp-Secure Staffing and LSE Staffing)
-
Bedford, MA
- Our client located in Bedford, MA is looking for a Clinical Research Associate to join their team on a direct hire basis...
- 4/21/2024 12:00:00 AM
Clinical Research Associate
- Alira Health
-
Boston, MA
- Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, ...
- 4/21/2024 12:00:00 AM
Clinical Research Associate
- Walker Cole International
-
Boston, MA
- Clinical Research Associate - Diagnostics Walker Cole International has partnered with a rapidly growing Diagnostics Com...
- 4/21/2024 12:00:00 AM
Clinical Research Associate/Sr. Clinical Research Associate
- Curevo Inc.
-
Bothell, WA
- The Clinical Research Associate/Sr. Clinical Research Associate assists the clinical operations team in the oversight, o...
- 4/19/2024 12:00:00 AM
Senior Clinical Research Associate
- Abbott Laboratories
-
Alameda, CA
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-chan...
- 3/28/2024 12:00:00 AM
About Minnesota
Minnesota (/ˌmɪnɪˈsoʊtə/ (listen)) is a state in the Upper Midwest and northern regions of the United States. Minnesota was admitted as the 32nd U.S. state on May 11, 1858, created from the eastern half of the Minnesota Territory. The state has a large number of lakes, and is known by the slogan the "Land of 10,000 Lakes". Its official motto is L'Étoile du Nord (French: Star of the North).
Minnesota is the 12th largest in area and the 22nd most populous of the U.S. states; nearly 60% of its residents live in the Minneapolis–Saint Paul metropolitan area (known as the "Twin Cities"). This area i...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Associate jobs
$69,888 to $92,310
Most Popular Cities in Minnesota for Clinical Research Associate Jobs
What does a Clinical Research Associate do?
Clinical Research Associate in Vista, CA
Represents Global Clinical Affairs on multifunctional teams tasked with preparing responses to regulatory agencies.
May 02, 2023
Clinical Research Associate in Stockton, CA
Document informed consent discussion and obtain signatures per protocol, federal, state and institutional requirements.
April 20, 2023
Clinical Research Associate in Stamford, CT
Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.
May 09, 2023
Participate in monitoring visit report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans.
December 03, 2022