• Senior Clinical Research Associate Jobs in United States Of America

  • Abbott India Ltd
  • United States Of America, Usa
  • Save Job
  • 1 - 3 Years
  • Posted : above 1 month

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 Working independently with minimal guidance and direction, assists in the planning and conduct of clinical studies Ensures compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Standard Operating Procedures Able to solve complex problems; considers alternative or new perspectives using existing tools and standard processes Focus is on site management activities such as collection of essential documents, identifying and obtaining missing data, data corrections, reviewing and trending adverse events and protocol deviations May contribute to developing study related materials; assists with writing reports and protocols May also provide oversight of vendors and committees such as core labs and safety boards

Essential Functions

Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects

This may include but is not limited to

Drafts study related materials such as patient brochures, patient recruitment material, and presentations
Drafts protocol summary, annual report, and other study reports
Drafts informed consent documents and ensures all required elements are included
Develops for review draft Case Report Forms and associated edit logic
Assists with site nomination, qualification, and selection processes
Can function to lead calls with FCE management if required
Provides product/protocol specific support and training to internal and external clinical personnel
In consultation with study management, the assigned field clinical personnel and appropriate in-house personnel, coordinates the start-up and maintenance of the clinical study sites
Coordinates and lead activities with study specific committees, vendor services, and core labs Reviews and analyzes data and documents for accuracy and completeness Can lead study team to clean and review data Creates and processes data queries
Assists with preparation, follow-up, and resolution of findings from monitoring visits and audits
Independently reviews site compliance and raises issues to study management
Can lead team meetings reviewing compliance concerns
Reviews and processes product complaints and adverse events as soon as they are reported
Drafts Serious Adverse Event or death narratives
Serves as a liaison to field clinical and site personnel by responding to any protocol-related issues and escalating as appropriate
Communicates and collaborates with all levels of employees, customers, contractors, and vendors
Applies general clinical research processes and regulatory knowledge to actively improve processes and efficiencies
Mentors less experienced clinical team members
Contributes to global process improvement teams Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates effectiveness and appropriateness
Exercises independent judgment in planning, organizing, and performing work; monitors performance and reports status to manager
Provides input to departmental Standard Operating Procedures (SOPs) and Departmental Work Instruction (DWIs)

Other Duties

Develops an understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies, and seeks continuing education about SJM devices and therapies Manages small projects and process improvement efforts that are critical to help support departmental goals and objectives May participate in Core Team activities and make additional contributions as assigned

Equipment

Uses standard office equipment, including (but not limited to) personal computer, telephone, FAX, and copier

Working Conditions

Normally works in a cubicle situated in open landscape office environment Air conditioned Well lighted Moderate noise level

Physical Demands

Primarily sitting Some walking Light effort related to moving, lifting and using office supplies and standard office items Performs tasks which regularly require good correctable vision and hand/eye coordination

This position may require up to approximately 25 PERCENT travel

Qualifications

Required

A Bachelor degree from an accredited university or college Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field
Minimum five years clinical research experience
Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational, technical writing, and problem solving skills Able to interpret clinical data, meet deadlines and work effectively with all levels of employees
Proficiency in Microsoft Office Suite and relevant clinical applications
The ability to work independently when necessary
The ability to exchange straightforward information, ask questions, and check for understanding

Desired

Advanced degree preferred with an academic focus in natural science, nursing, bioengineering or a related academic field
An excellent understanding of all aspects of clinical research A general familiarity with cardiac, vascular, and/or neuromodulation technologies Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment
Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP)
Work habits include organization, coordination of many tasks, accuracy, and attention to detail

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 15th Jan 2020

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