Clinical Research

• Oversee and manage clinical trial activities according to protocol, regulatory requirements, and industry standards
• Lead clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement
• Monitor clinical trial sites for adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
• Conduct site visits to assess site performance, resolve issues, and support successful trial execution
• Collaborate with cross-functional teams to ensure timely and accurate data collection and reporting
• Provide training and guidance to site staff and other CRAs
• Build and maintain relationships with site personnel and stakeholders to facilitate smooth trial operations

Senior Clinical Research Associate

• Lead assigned clinical research activities
• Partner with stakeholders, investigators and KOLs to develop study designs, concepts, protocols and study outlines
• Plan and execute pre-market and post-market clinical studies
• Manage site selection, patient recruitment projections, site start-up, enrollment and follow-up
• Prepare protocols, case report forms, informed consents, clinical trial agreements and study reports
• Organize IRB/EC submissions and follow through on study progress
• Conduct studies on schedule, within budget, with high quality and compliance
• Perform site qualification, initiation, interim monitoring and close-out visits, both on-site and remotely
• Conduct monitoring for regulatory and protocol compliance and data accuracy
• Complete source data verification in EDC systems, case report forms or data listings
• Liaise with sites and support internal audits, inspections and sponsor audit readiness
• Negotiate vendor and site contracts and budgets with legal and management
• Track study progress, provide status reports and manage site payments and financial tracking
• Collaborate with biostatisticians on data analysis, interpretation, clinical study reports and scientific publications
• Organize study meetings and activities
• Mentor junior clinical study managers and guide CRAs and CTAs
• Follow corporate SOPs, GCP and US/OUS regulatory guidelines
• Conduct literature searches, critically appraise scientific literature and write clinical summaries
• Review and revise Clinical Operations SOPs for process improvement
• Support post-market research, market-trend analysis and Health Economics and Outcomes Research activities
• Work with investigators on manuscripts, abstracts, slide presentations and posters
• Support regulatory submissions and approvals for pre-market studies and 510(k)s, including responses to regulatory questions

Senior Clinical Study Manager

• Advance AbbVie’s clinical research pipeline and support innovative medicines and solutions
• Serve as the primary sponsor point of contact for investigative sites
• Partner with study teams, internal R&D stakeholders, investigators, and site staff
• Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles
• Mentor and support junior CRAs and support local onboarding
• Conduct site evaluation, site training, routine onsite and offsite monitoring, and site closure monitoring
• Ensure compliance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, SOPs, and quality standards
• Customize site engagement strategies and track progress and impact
• Support recruitment and retention techniques based on the patient disease journey
• Conduct continuous risk assessment with the Central Monitoring team
• Resolve site risk signals and implement preventative and corrective action plans
• Identify, evaluate, and recommend investigators and clinical sites
• Ensure data quality, timely data submission, and appropriate safety-event reporting and follow-up
• Maintain audit and regulatory inspection readiness
• Manage investigator payments according to executed contract obligations
• Participate in or lead global and local task forces and initiatives
• Perform additional activities assigned by the manager

• Conduct field monitoring of studies and data collection for clinical trials
• Assess data documentation, reports, records, transcripts, and exam results for consistency with case report forms
• Determine whether clinical trial/study subject documentation aligns with the study hypothesis
• Monitor clinical trial/study safety in accordance with protocols, GCP, and regulatory requirements
• Provide oversight and insights into trial activities, including protocol compliance, enrollment, monitoring deviations, and data quality
• Report findings to principal investigators, support staff, sponsor management, leadership, Institutional Review Boards/Ethics Committees, Research Ethics Committees, and Clinical Operations
• Recommend and develop process improvements
• Verify trial/study data and maintain appropriate internal and external regulatory documents
• Audit sites for appropriate regulatory documentation and proper source documentation
• Validate investigational device accountability from Edwards through field sites and final disposition
• Develop and deliver training on GCPs, protocols, databases, compliance, device accountability, adverse event reporting, investigation protocols, amendments, and regulatory documentation
• Train and proctor new employees on trial- and study-related activities

Clinical Research Monitoring Specialist

• Provide a high standard of care for participants in clinical trials
• Respond to emergency situations according to clinical research standards
• Conduct routine monitoring and close-out of clinical sites
• Maintain study files
• Conduct pre-study and initiation visits
• Liaise with vendors
• Manage study sites according to project plans
• Ensure study staff receive proper materials and instructions to safely enter patients into the study
• Verify informed consent procedures and protocol requirements comply with applicable regulatory requirements
• Ensure data integrity in Case Report Forms and other data collection tools
• Monitor data for missing or implausible data
• Manage study registries and undertake feasibility work when requested
• Complete Serious Adverse Event reporting, narratives, reports, and follow-up
• Perform CRF review and query generation and resolution using Fortrea or client data management systems
• Assist with training new employees through co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator, with supervision where applicable
• Act as a local client contact when assigned
• Perform other duties as assigned by management
• Travel frequently to client and site locations, including occasional domestic and international travel

Clinical Research Associate II, Phase I

• Plan, conduct, and document on-site and remote monitoring visits, including SQVs, SIVs, IMVs, and COVs
• Apply risk-based monitoring to evaluate site performance, protocol compliance, data quality, subject safety, and documentation completeness
• Conduct source data verification and source data review
• Manage site relationships, enrollment, query resolution, protocol compliance, study timelines, and site performance
• Identify and document monitoring findings, site risks, protocol deviations, compliance concerns, and data trends; escalate issues with corrective actions
• Prepare monitoring visit reports and follow-up correspondence
• Track findings and action items through resolution and verify effectiveness
• Maintain essential regulatory and study documents for inspection readiness
• Lead site start-up and closeout activities
• Collaborate with Clinical Trial Managers and cross-functional partners on monitoring insights and risk assessments
• Mentor junior CRAs and CTAs
• Monitor adverse events and serious adverse events and escalate safety concerns
• Develop and verify corrective and preventive action plans
• Maintain Investigator Site Files and Trial Master File documentation
• Support site staff training and retraining on protocols, eClinical systems, specimen handling, and study procedures

• Serve as lead Clinical Scientist for an assigned clinical trial from study planning through analysis and reporting
• Provide scientific oversight for clinical trial execution
• Contribute to clinical protocols, protocol amendments, informed consent forms, case report forms, data review plans, and other study documents
• Partner with Clinical Directors and cross-functional study teams to align objectives, endpoints, and assessments with development strategy
• Maintain knowledge of scientific literature, treatment guidelines, competitive developments, and emerging therapies
• Lead ongoing clinical data review and interpretation for safety, protocol adherence, data quality, and study conduct
• Collaborate with Medical Monitors and Clinical Directors to evaluate safety signals, protocol deviations, patient profiles, laboratory findings, and efficacy outcomes
• Analyze clinical trial data to identify trends and generate scientific insights
• Contribute to study reports, regulatory documents, publications, scientific presentations, and governance materials
• Collaborate with Clinical Operations, Data Management, Programming, Biostatistics, and Regulatory Affairs
• Provide scientific guidance to study teams and mentor junior clinical scientists as appropriate
• Communicate scientific concepts and study findings to technical and non-technical audiences
• Influence decisions and drive alignment within a matrix-based global organization

Senior Clinical Scientist, Immunology

• Provide a high standard of care for participants in clinical trials and respond to emergency situations based on clinical research standards
• Perform all aspects of study site monitoring, including routine monitoring and close-out of clinical sites
• Maintain study files and conduct pre-study and initiation visits
• Liaise with vendors and perform other assigned duties
• Manage study sites according to project plans
• Ensure study staff receive proper materials and instructions to safely enter patients into studies
• Verify informed consent procedures and protocol requirements comply with applicable regulations
• Ensure data integrity in Case Report Forms and other data collection tools by carefully monitoring source documents
• Monitor data for missing or implausible information
• Manage clinical trial registries and conduct feasibility work when requested
• Complete Serious Adverse Event reporting, including reports, narratives, and follow-up
• Independently review CRFs and generate and resolve queries using Fortrea or client data management systems
• Assist with training new employees through activities such as co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator, with supervision where applicable
• Act as a local client contact when assigned

Clinical Research Associate 2

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. 
JOB DESCRIPTION:

Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

- Career development with an international company where you can grow the career you dream of.

- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

- An excellent retirement savings plan with a high employer contribution.

- Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.

- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity:
Our Core Lab business unit currently has an opportunity for a Clinical Research Associate I. This role is based remote in the United States near a major airport.
Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. 

What You’ll Work On:
As a Clinical Research Associate (CRA), you will support clinical trial sites from study start-up through closeout, ensuring studies are conducted in compliance with protocols, regulatory requirements, and company procedures.
This role reports to the Clinical Manager and partners with Clinical Project Teams and Operations leadership. The successful candidate will work in a regulated quality environment, manage assigned tasks and timelines, build cross-functional relationships, and contribute to study success under general supervision.

Key Responsibilities:

- Conduct site qualification, initiation, monitoring, and closeout visits.

- Provide training and support to investigators, study coordinators, and site staff.

- Monitor protocol compliance, data quality, and Good Clinical Practice (GCP) requirements.

- Review source documents and verify clinical study data for accuracy and completeness.

- Ensure only eligible participants are enrolled in studies.

- Manage and maintain study and regulatory documentation.

- Monitor investigational product accountability and inventory.

- Review adverse event reporting for accuracy and compliance.

- Assess site performance, including patient recruitment and retention efforts.

- Prepare monitoring reports and communicate findings, risks, and corrective actions.

- Build strong relationships with clinical research sites and internal stakeholders.

- Develop knowledge of applicable clinical research regulations and study types.

Required Qualifications

- Bachelor's (life sciences or clinical research preferred) or equivalent combination of education and work experience.

- Minimum 1-year clinical research experience required.

- Must be detail-oriented and efficient in time management.

- Must have excellent written and verbal communication, organizational and presentation skills.

- Must be able to work effectively with others.

- Self-directed and able to work within a fast paced and constantly changing environment.

- Ability to multitask, prioritize, and manage time efficiently.

- Proficient computer skills, including Microsoft Office Suite (Word, Excel, Outlook, etc.).

- Travel: 40 % 

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

The base pay for this position is 
$61,300.00 – $122,700.00In specific locations, the pay range may vary from the range posted.
     
JOB FAMILY:
Medical & Scientific Affairs 
DIVISION:
CRLB Core Lab 
LOCATION:
United States of America : Remote 
ADDITIONAL LOCATIONS:
United States > California : Remote 
WORK SHIFT:
Standard 
TRAVEL:
Yes, 50 % of the Time 
MEDICAL SURVEILLANCE:
Yes 
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment, Keyboard use (greater or equal to 50% of the workday), Lift, carry, push or pull weights of more than 20 pounds/9 kilos on a regular/daily basis, Work with human blood or other potentially infectious materials, Work with infectious organisms or known infectious materials 
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.     
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf     
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Clinical Research Associate I

• Own the full lifecycle of clinical evidence generation from gap analysis through literature review, study conception, protocol development, data collection and analysis, to manuscript authorship and publication in peer-reviewed journals
• Author and present scientific communications, including abstracts, manuscripts, posters, and presentations, for peer-reviewed and commercial audiences at scientific conferences and congresses
• Manage the clinical evidence library and publication pipeline, maintaining timelines and coordinating with Regulatory and Marketing on publication and presentation strategy
• Support regulatory submissions with clinical evidence and clinical trial results, including FDA 510(k)
• Contribute to prospective and retrospective clinical study design for existing and future products
• Interface with study investigators, KOL advisors, and internal Data Science, Regulatory, Marketing, and Product teams
• Maintain relationships with clinical and scientific leaders to advance study execution, analysis, and results dissemination
• Develop and execute conference activities, including abstract/presentation submissions, KOL engagement, and investigator coordination
• Partner with Marketing, Sales, and Go-to-Market teams to develop clinical evidence summaries, infographics, and data visualizations while ensuring scientific integrity, data accuracy, and regulatory compliance
• Perform other responsibilities as assigned by the Manager/Supervisor

Clinical Research jobs in California

Senior Clinical Research Associate

Senior Clinical Study Manager

Senior Clinical Research Associate

Clinical Research Monitoring Specialist

Clinical Research Associate II, Phase I

Senior Clinical Research Associate

Senior Clinical Scientist, Immunology

Clinical Research Associate 2

Clinical Research Associate I

Principal Clinical Research Scientist