Clinical Research Spec - Exempt

OVERVIEW We are currently seeking a detail-oriented Clinical Research Specialist to join a well-known client’s team in Mounds View, MN. This role is responsible for supporting the design, execution, and management of clinical research studies, ensuring compliance with regulatory requirements and industry standards. The Clinical Research Specialist will work closely with cross-functional teams to oversee clinical trial activities from planning through execution, contributing to the successful development of medical devices that meet both clinical and commercial needs. This position offers the opportunity to play a key role in advancing innovative therapies within a collaborative and fast-paced environment. RESPONSIBILITIES •    Support the design, planning, and execution of clinical research studies, including both registered and non-registered trials. •    Author and contribute to clinical protocols, case report forms (CRFs), and study documentation. •    Oversee and manage operational aspects of clinical trials in accordance with SOPs, Good Clinical Practice (GCP), and applicable regulatory requirements. •    Conduct site management activities, including site selection, monitoring support, and vendor coordination. •    Utilize and manage clinical systems such as CTSM, EDC, and TMF to ensure accurate and compliant data handling. •    Analyze and interpret clinical study results to support regulatory submissions and product development. •    Assist with clinical trial budgeting, timelines, and resource planning. •    Support clinical supply management activities as needed. •    Collaborate with cross-functional stakeholders to resolve study issues and ensure milestone delivery. •    Maintain clear and accurate communication of project status, risks, and updates to internal teams. •    Provide guidance or mentorship to junior team members when appropriate. •    Contribute to process improvements and recommend enhancements to clinical operations workflows. EXPERIENCE •    Minimum of 2+ years of clinical research experience with a Bachelor’s degree, OR 0+ years with an advanced degree. •    Hands-on experience with site management (sponsor or site side) strongly preferred. •    Experience working with clinical systems (CTSM, EDC, TMF) required. •    Solid understanding and application of Good Clinical Practice (GCP) guidelines. •    Experience managing clinical trial operations in a regulated environment. EDUCATION •    Minimum of a Bachelor’s degree in life sciences, medical, or a related scientific field required. TO BE A BEST FIT, YOUR STRENGTHS MUST INCLUDE •    Strong organizational and project management skills, with the ability to manage multiple priorities. •    Excellent communication and interpersonal skills, with the ability to collaborate across teams. •    Ability to work independently with general supervision on moderately complex projects. •    Strong attention to detail and commitment to accuracy and compliance. •    Analytical mindset with the ability to interpret clinical data and identify issues. •    Proactive problem solver with the ability to suggest process improvements. •    Ability to mentor or support junior team members as needed.   Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com. #MSPTalent