Clinical Research Associate - Remote

Solventum-; Eagan (MN); Remoto; USD 106.000 - 146.000; Tempo pieno

Vantaggi offerti da questo lavoro

Travel up to 75%

Competitive benefits

Remote-friendly position

Descrizione del lavoro

Solventum- is seeking a Clinical Research Associate to support remote-site monitoring and regulatory activities. You will manage TMF, oversee site initiation and visits, and train staff on sponsor requirements while ensuring data integrity and compliance across multiple studies.

The role requires a degree plus CRA experience, with up to 75% travel. Strong communication and problem-solving skills are essential for success in a collaborative, global environment.

Competenze

• Bachelor’s degree with 3+ years in clinical research, including 2+ years in CRA monitoring.
• Or a High School Diploma with 7+ years in clinical research, including 5+ years CRA monitoring.
• Experience with medical devices and regulatory requirements is preferred.

Mansioni

• Ensure TMF and regulatory files are prepared, collected, and maintained at investigative sites.
• Conduct site visits, monitor trials, and train site personnel on sponsor/regulatory requirements.
• Review data queries, resolve discrepancies, and ensure compliance with regulations.
• Collaborate with the Clinical Project Manager and cross-functional teams throughout the study.
• Assist with device preparation, shipment coordination, and accountability records.

Conoscenze

CRA monitoring

Clinical setting experience

Communication skills

Problem solving

Project prioritization

Multitasking

Formazione

Bachelor's degree or higher

High School Diploma/GED

Strumenti

Smartsheet

Microsoft Copilot

Microsoft 365

Descrizione del lavoro

At Solventum, we improve lives by helping healthcare professionals do their best work. Join a team using innovation and insight to make a real impact on the future of healthcare. All roles listed are with Solventum, and we’re committed to protecting your personal information—learn more in our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/Job Description:Clinical Research Associate - Remote3M Health Care is now SolventumAt Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.The Impact You’ll Make in this RoleAs a Clinical Research Associate, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:Ensuring preparation, collection, and distribution of trial master file (TMF) documents and maintenance of regulatory files at investigative siteConducting pre-study site visits, collecting and reviewing site feasibility and operational processes information, and preparing reports; participating in the final selection of investigators and study sitesConducting clinical study site initiation visits; advising and training site personnel on Sponsor and regulatory requirements for study conductConducting site monitoring visits and following-up to identify significant problems and issues and ensuring that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policiesReviewing on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifying deficiencies and discrepancies, and providing remedial training and/or initiating corrective action as requiredReviewing case report form queries and problems, and clarifying and/or obtaining changes to data as appropriateCollaborating closely with the Clinical Project Manager, cross functional study teams and all Research partners, internal and external to companyAssisting with device preparation, shipment coordination and maintaining appropriate accountability recordsYour Skills and ExpertiseTo set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:Bachelor’s degree or higher (completed and verified prior to start) from an accredited institution AND three (3) years of clinical research, biomedical, or medical device industry experience in a private, public, government or military environment, which must include two (2) years of direct Clinical Research Associate (CRA) experience conducting clinical study monitoring activities.ORHigh School Diploma/GED (completed and verified prior to start) AND seven (7) years of clinical research, biomedical, or medical device industry experience in a private, public, government or military environment, which must include five (5) years of direct Clinical Research Associate (CRA) experience conducting clinical study monitoring activities.Additional qualifications that could help you succeed even further in this role include:Direct CRA monitoring experience monitoring medical device clinical studies.Experience working in hospital or clinical setting or medical laboratoryUses Smartsheet, Microsoft Copilot, and Microsoft 365 applications to manage, track, analyze, and communicate work-related information.Background in preparing and delivering verbal, written, and presentation communications regarding project status, issues, and escalations to relevant stakeholders.Identifies problems, evaluates potential solutions, and supports resolution of business or project issues.Prioritizes, plans, tracks, and evaluates deliverables against established requirements and timelines.Manages multiple concurrent tasks and adjusts priorities based on changing business needs and deadlines.Work location: RemoteTravel: May include up to 75%Relocation Assistance: Is not authorizedMust be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).Supporting Your Well-beingSolventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.Applicable to US Applicants Only:The expected compensation range for this position is $106,000 - $145,750, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-RewardsResponsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com . Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.Solventum Global Terms of Use and Privacy StatementCarefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.Please access the linked document by clicking here . Before submitting your application you will be asked to confirm your agreement with theterms.