Abbott

Safety Clinical Research Associate (on-site)

Abbott • $61K — $122K *
Maple Grove, MN 55311In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree
  • 2 years of related experience or equivalent education and work experience
  • 1 year of experience in conducting clinical research or related scientific laboratory skills
  • Preferred background in Life Sciences, Nursing, Pharmacy, or Clinical Research
  • Clinical Research Certification or Medical Technology credentials preferred

Responsibilities

  • Collect, track, review, and manage clinical safety source documentation
  • Create and maintain inspection-ready documentation for regulatory submittals
  • Coordinate activities for Clinical Events Committees and Data Monitoring Committees
  • Draft adverse event narratives and ensure regulatory compliance
  • Support translation coordination for safety-related documents

Benefits

  • Health and wellness benefits supporting family wellness
  • Opportunities for professional development and advancement
  • Collaborative team environment
  • On-site work location in Maple Grove, MN
  • Potential for limited travel (10%)
Full Job Description
JOB DESCRIPTION:

The Opportunity

The Safety Clinical Research Associate (CRA) is responsible for supporting clinical safety and medical affairs activities through the collection, review, preparation, and management of clinical safety documentation and operational processes. The role provides critical support for safety committees, case narratives, source document management, translation coordination, and regulatory inspection readiness while ensuring compliance with applicable procedures and regulatory requirements. This new team member will work on-site at our Maple Grove, MN location.

What You'll Work On

Safety Documentation and Source Record Management
  • Collect, track, review, and manage source documentation associated with adverse events, serious adverse events, complaints, and clinical investigations.
  • Ensure source documents are complete, legible, and appropriately filed within designated safety systems and repositories.
  • Perform redaction of protected health information (PHI) and personally identifiable information (PII) in compliance with privacy and regulatory requirements.
  • Create, verify, and maintain bookmarked and inspection-ready PDF packages for regulatory submissions, audits, and committee reviews.
  • Maintain document inventories, tracking logs, and reconciliation records to ensure completeness and timely processing of safety documentation.
  • Coordinate retrieval of missing or outstanding records from study sites, investigators, vendors, and other stakeholders.

Clinical Event Committee (CEC) and Data Monitoring Committee (DMC) Support
  • Coordinate operational activities for Clinical Events Committees (CEC), Data Monitoring Committees (DMC), and other safety governance committees.
  • Schedule committee meetings and facilitate communication among committee members, investigators, and internal functional teams.
  • Prepare and distribute meeting agendas, briefing packages, committee dossiers, and supporting documentation.
  • Manage committee document workflows, including redaction, quality review, version control, and archival activities.
  • Track committee actions, recommendations, decisions, and deliverables and ensure timely follow-up.
  • Support preparation of data listings, safety summaries, and endpoint review documentation for committee evaluations.

Narrative Development and Medical Writing Support
  • Draft and maintain adverse event, serious adverse event, complaint, and endpoint adjudication narratives using available clinical and source documentation.
  • Ensure narratives are medically accurate, consistent, complete, and compliant with company procedures and applicable regulatory expectations.
  • Collaborate with Clinical Safety Physicians, Medical Directors, and Safety Specialists to resolve data queries and narrative discrepancies.
  • Support preparation and quality review of clinical safety reports and supplemental safety documentation.

Translation and Vendor Coordination
  • Coordinate translation requests for safety-related source documents, medical records, narratives, and committee materials.
  • Liaise with approved translation vendors to ensure timely delivery and quality of translated documents.
  • Review translated content for consistency, completeness, and alignment with source documentation.
  • Maintain translation tracking logs and associated documentation.

Clinical Safety Operations Support
  • Support safety case processing activities through document acquisition, reconciliation, and quality control.
  • Participate in safety data review activities and assist in identifying incomplete or inconsistent documentation.
  • Contribute to inspection readiness efforts by ensuring documentation is organized, traceable, and audit-ready.
  • Assist in development and maintenance of standard operating procedures, work instructions, templates, and tracking tools.
  • Collaborate with cross-functional teams including Clinical Operations, Medical Affairs, Regulatory Affairs, Data Management, Quality, and external vendors.
  • Maintain compliance with Good Clinical Practice (GCP), applicable regulations, privacy requirements, and company policies.

Responsibilities for All Functions
  • This job description is intended to describe the general nature and level of work performed by individuals assigned to this position and is not intended to be an exhaustive list of responsibilities.
  • Perform additional duties as assigned consistent with business needs and professional capabilities.


Required Qualifications:
  • Bachelor's degree
  • 2 years of related experience; or equivalent combination of education and work experience
  • 1 year of experience in conducting clinical research or related scientific laboratory skills.


Preferred Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, Health Sciences, Clinical Research, or related field.
  • Clinical Research Certification (e.g., CCRA, CCRC, CPI). Medical Technology (e.g., MLT/MT, CLS)
  • 2-5 years of experience in Clinical Research, Clinical Safety, Pharmacovigilance, Medical Affairs, or related healthcare environment.
  • Experience supporting adjudication committees, safety review boards, or clinical trial operations preferred.
  • Experience handling medical records, source documentation, and regulated clinical documents
  • Knowledge of clinical research processes and Good Clinical Practice (GCP).
  • Understanding of safety reporting and medical terminology.
  • Strong document management, quality review, and organizational skills.
  • Experience with PDF redaction, bookmarking, and document preparation tools.
  • Strong written communication and narrative writing skills.
  • Ability to coordinate multiple stakeholders and manage competing priorities.
  • Proficiency with Microsoft Office applications and electronic document management systems.
  • Attention to detail with demonstrated ability to maintain accuracy and confidentiality.


Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

The base pay for this position is
$61,300.00 - $122,700.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Medical & Scientific Affairs

DIVISION:
MD Medical Devices

LOCATION:
United States > Maple Grove : 6820 Wedgwood Road N.

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 10 % of the Time

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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