Clinical Research Associate - Remote

SOLVENTUM; Oregon; Ibrido; USD 106.000 - 146.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, Dental & Vision

Health Savings Accounts

Health Care & Dependent Care Flexible;

Disability Benefits

Life Insurance

Voluntary Benefits

Paid Absences

Retirement Benefits

Descrizione del lavoro

Solventum is seeking a Clinical Research Associate (CRA) to join our remote team in the United States. You will monitor trials, ensure TMF and regulatory file integrity, and collaborate with cross-functional teams to drive compliant study execution.

Required qualifications include a bachelor’s degree with CRA experience or a high school diploma with extensive CRA background. Travel up to 75% is noted, with strong emphasis on regulatory knowledge and data accuracy.

Competenze

• Bachelor-level plus 3 years of clinical research/medical device experience, including 2 years in CRA monitoring.
• High School Diploma plus 7 years in clinical research/medical device fields, including 5 years CRA monitoring experience.

Mansioni

• Ensure preparation, collection, and distribution of TMF documents and regulatory files at sites.
• Conduct pre-study site visits and assist in investigator/site selection.
• Train site personnel on sponsor and regulatory requirements for study conduct.
• Perform site monitoring visits and address regulatory/compliance issues.
• Review source documents and CRFs for accuracy and completeness; remediate deficiencies.
• Investigate CRF queries and changes; coordinate data clarification as needed.
• Collaborate with Clinical Project Manager and cross-functional teams.
• Assist with device preparation, shipment coordination, and accountability records.

Conoscenze

Clinical research

Regulatory knowledge

Site monitoring

Formazione

Bachelor's degree + 3 years CRA experience

High School Diploma + 7 years CRA experience

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:Job Description:Clinical Research Associate - Remote

3M 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.

Impact You'll Make in this Role

As 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 site
• Conducting 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 sites
• Conducting clinical study site initiation visits; advising and training site personnel on Sponsor and regulatory requirements for study conduct
• Conducting 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 policies
• Reviewing 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 required
• Reviewing case report form queries and problems, and clarifying and/or obtaining changes to data as appropriate
• Collaborating closely with the Clinical Project Manager, cross functional study teams and all Research partners, internal and external to company
• Assisting with device preparation, shipment coordination and maintaining appropriate accountability records

Your Skills and Expertise

To 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.
• High 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 laboratory
• Uses 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: Remote

Travel: May include up to 75%

Relocation Assistance: Is not authorized

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well-being

Solventum 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.

• Medical, Dental & Vision
• Health Savings Accounts
• Health Care & Dependent Care Flexible Spending Accounts
• Disability Benefits
• Life Insurance
• Voluntary Benefits
• Paid Absences
• Retirement Benefits

Additional information is available at: 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.

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