Sr. Clinical Research Associate/Clinical Research Associate

Job description

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Note: Will consider lighter-experienced candidates; If selected for position, will be offered position as Clinical Research Associate.

Position Overview:

• The Sr. Clinical Research Associate (SCRA) designs, implements, and monitors clinical studies of new and modified In Vitro Diagnostic (IVD) products.
• Ensures that the clinical studies are conducted per established policies, procedures, regulations, and Good
• Clinical Practice (GCP).
• Participates in the preparation of regulatory submissions and international registration packages.
• Works with minimal supervision on a single large project, a complex project, or several smaller projects.
• Has established a high degree of competence in clinical research. Has obtained prior exposure to all aspects of a clinical study and functions at a proficient level of independence with a significant degree of autonomy in conducting clinical research.

Major Responsibilities:

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Complies with all policies, established procedures, and regulations related to clinical research.
• Actively participates as a member of the cross-functional project team.
• Participates in assessing performance data generated by R&D/Business Teams prior to initiation of the clinical study.
• Acquires a basic understanding of the principles of the assay and/or instrument and “hands-on” knowledge and skills in performing assigned assays or operating instruments.
• Prepares clinical plans that meet product design goals, intended use, regulatory requirements, divisional operating procedures, and Clinical Research work instructions.
• Prepares clinical protocol, clinical brochure, case report forms, informed consents, and other required documents for clinical studies.
• Identifies and qualifies clinical investigators and clinical sites.
• Proposes and negotiates budgets for clinical studies. Initiates payments to clinical sites.
• Obtains and reviews all required essential documents necessary for study initiation.
• Collaborates with Statistical Support with the collection and statistical analyses of clinical data.
• Monitors clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines; assures subject rights, safety, and welfare are protected; ensures data integrity through completeness, accuracy, and legibility.
• Conducts pre-study, initiation, interim, and closeout monitoring site visits and completes site visit reports.
• Maintains accurate and timely sponsor/site correspondence and communication.
• Reviews data, prepares, and presents clinical data reviews and data summaries.
• Responds to audits and data queries.
• Prepares and presents project progress reports to keep management and team informed.
• Prepares the clinical sections of regulatory submissions and international registration packages.
• Assists Regulatory in preparing responses to regulatory agencies’ questions regarding the clinical study.
• Maintains professional, product, and market expertise via independent reading, networking, and training.
• Functions independently in the field and interacts with all levels of medical and scientific professionals.
• Advises and supports newly hired CRAs with department procedures.
• Suggests improvements for increased departmental efficiency.
• May perform other duties as assigned.
• Travel: up to 25-30% (US only)

Required Education:

• B.A. or B.S. in the biological sciences, Masters degree is preferred, or equivalent clinical research experience of 8 to 9 years.
• Other: Medical Technology MT(ASCP) or equivalent, or certification as a clinical research associate (CCRA) is desirable.

Required Experience:

• This position requires an understanding of the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage, and the scientific, statistical, regulatory, and compliance requirements for conducting clinical research.
• Minimum of 6 years relevant professional experience including:
• Clinical Research 2 to 3 years and Laboratory (hospital, research, industrial) 3 to 4 years - or -
• Quality Assurance/Auditing 1 to 2 years - or -
• Customer Contact 1 to 2 years
• Other: This position requires good oral and written communication skills, familiarity with desktop computer office software, ability to travel (25-30%, US), and participation in professional activities outside of normal business hours.

Preferred Experience:

• 5-6 years' experience in monitoring of clinical sites or clinical studies/site management, etc.
• Above work experience, highly preferred from any of the following: IVD (In Vitro Diagnostics) manufacturers; CRO (Clinical Research Organizations) or similar; or from research hospitals.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: