Clinical Research Associate I - Remote (Usa Only)

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 115,000 colleagues serve people in more than 160 countries.

CLINICAL RESEARCH ASSOCIATE I – REMOTE (USA ONLY)

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Family, Be Your True Self And Live a Full Life. You’ll Also Have Access To

• An excellent retirement savings plan with high employer contribution
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• Career development with an international company where you can grow the career you dream of.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

The Opportunity

Our Diagnostics business currently has an opportunity for a

CLINICAL RESEARCH ASSOCIATE I.

This position is based REMOTE - USA ONLY.

Travel: 40 % (mostly within USA but on rare occasion, international).

The primary function of this position is to manage sites through life of trial and close-out, including, the implementation, coordination and conduct of clinical research activities in compliance with applicable Corporate and Divisional Policies and Procedures under supervision of the Clinical Manager.

What You’ll Work On

Core Job Responsibilities

Under supervision of the Clinical Manager, responsible for the following:

• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff.
• Responsible for investigational product accountability and inventory.
• Basic knowledge in regulations for applicable geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.).
• Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators and site staff.
• Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; and
• Verification that the investigator is enrolling only eligible subjects/samples.
• Ensures timely collection and review of study and regulatory documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures and regulations.
• Source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements.
• Builds and maintains relationships with sites
• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol.
• Communication with site staff including coordinators, clinical investigators, and their site staff;
• Verification and review of adverse events to confirm accurate data reporting in accordance with the protocol.
• Timely completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Note: This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role.

Supervisory / Management Responsibilities

Exempts/ Non-Exempts/ Contingent: 0

Direct Reports: 0

Indirect Reports: 0

Position Accountability

Reporting And Peer Relationships

This entry level position reports to the Clinical Manager.

This position will interface with Clinical Project Teams, Research and Operational Managers who determine study objectives and resource needs.

Position Scope

Begins establishing and cultivating a network of internal resources to facilitate completion of tasks. Will perform this job in a quality system environment. Completes daily work to meet established schedule with guidance from supervisor on prioritization of task. Minimal independent decision making; exercises authority within pre-established limits and approval. Individual influence is typically exerted at the peer level.

Required Qualifications

Minimum Education

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

Minimum Experience / Training Required

• Must be detail-oriented and efficient in time management.
• Self-directed and able to work within a fast paced and constantly changing environment.
• Must have excellent written and verbal communication, organizational and presentation skills.
• Proficient computer skills, including Microsoft Office Suite (Word, Excel, Outlook, etc.).
• Ability to multitask, prioritize, and manage time efficiently.
• Minimum 1-year clinical research experience required.
• Must be able to work effectively with others.