Minneapolis, MN, United States
Clinical Research, Pharmaceutical, Research
Sep 23, 2021
Jan 06, 2022
The Sr. Clinical Research Associate (US) will support in-house clinical research activities and remote/onsite monitoring of assigned sites that are actively participating in Nuvaira clinical trials. Under the direction of the Clinical department lead, the Sr. Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with overall study execution. The Sr. CRA will also assist with data review and may assist with vendor management and creation/maintenance of study documentation/plans as needed.
Act as primary point of contact with assigned clinical study sites;
Facilitate timely and accurate communication flow between the clinical study sites, sponsor and applicable vendors;
Collaborate with clinical study sites to trouble shoot and provide appropriate solutions to study-related issues, as appropriate;
Review data entered into study EDC by assigned clinical study sites and apply queries as required;
Working with finance and legal experts, drive contract and budget negotiations (or amendments) with assigned study sites;
Review site-level clinical study documents for completeness, accuracy and compliance with GCP, sponsor SOPs and relevant regulations;
Assist assigned study sites with IRB submissions (g., perform sponsor review of submission documents) and/or submit to central IRB on behalf of sites;
Support study initiation, monitoring, audit and close out phases of assigned clinical trials as prescribed in the sponsor SOPs, study protocol and monitoring plan;
Support site payment and accrual activities associated with assigned clinical study sites;
Manage study device stock at assigned clinical study sites (g., orders, RMAs, ongoing accountability and final reconciliation);
Manage clinical study vendor(s) as requested by project management;
Create/maintain study plan(s) as requested by project management;
Assist with patient recruitment activities;
Assist with internal and external study-related training/re-training;
Assist with the development/continuous improvement of study-related documents as requested;
Bachelor’s degree (or higher) in nursing, health sciences or related field;
Minimum of 4 years medical device industry experience, IDE study experience preferred;
In-house and monitoring CRA experience preferred (g., familiarity with standard study plans, clinical trial operations, monitoring, study audits);
Strong oral and written communication skills;
Good understanding of global regulations related to clinical trials (g., 21 CFR 812, ISO14155) and ICH GCP;
Proven organizational skills and the ability to manage multiple priorities;
Strong computer skills;
Ability to work independently under general supervision;
Ability to travel up to 50% during peak periods.
Physical Job Requirements:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.