Clinical Research Associate (90909)

Task Impetus Inc.; New York (NY); On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

Increment of at least 15% every six months

Relocation charges provided

Medicinal, Dental and Vision benefits after 60 days

401k retirement benefits after six months

Pre-job training with experienced trainers

Visa Sponsorship

Job summary

A leading healthcare organization in New York is seeking a Clinical Research Associate (CRA) to oversee clinical trials and ensure compliance with regulations. This role requires a degree in a scientific discipline and experience in the healthcare sector. Key responsibilities include developing trial protocols, managing regulatory applications, and monitoring trial sites. The role offers excellent growth opportunities with a minimum increment of 15% every six months and comprehensive benefits including medical coverage and 401k plans.

Qualifications

• 2-3 years experience in healthcare industry and/or clinical trials environment preferred.

Responsibilities

• Develop and write trial protocols outlining purpose and methodology.
• Monitor clinical tasks for correct functioning and completion.
• Coordinate with the ethics committee to ensure the safety of trial subjects.
• Manage regulatory authority applications and approvals.
• Train site staff to trial-specific industry standards.
• Monitor trial duration and address any issues that arise.

Skills

Organizational skills

Time management

Problem-solving skills

Very good computer skills including MS Office

Ability to establish and maintain effective working relationships

Education

University degree in scientific discipline or health care

Job description

Overview

As a clinical research associate (CRA), you are responsible for completing clinical research and administrative tasks for clients. You facilitate documentation for clinical research. As a CRA, you monitor clinical tasks for correct functioning and completion, evaluate clinical data, and create reports based on findings.

Responsibilities

• Develop and write trial protocols (outlining purpose and methodology)
• Present trial protocols to a steering committee
• Design data collection forms, known as case report forms (CRFs)
• Coordinate with the ethics committee, which safeguards the rights, safety and well being of all trial subjects
• Manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
• Identify and assess the suitability of facilities to use as the clinical trial site
• Identify/select an investigator who will be responsible for conducting the trial at the trial site
• Liaise with doctors, consultants or investigators on conducting the trial
• Set up the trial sites – ensuring each centre has the trial materials, including the trial drug often known as the investigation medicinal product (IMP)
• Train the site staff to trial-specific industry standards
• Monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with and solving any issues
• Verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
• Collect completed CRFs from hospitals and general practices
• Write visit reports and file and collate trial documentation and reports
• Meet with team members to discuss ongoing trials, results and any trends or adverse events
• Ensure all unused trial supplies are accounted for
• Close down trial sites on completion of the trial
• Discuss results with a medical statistician, who writes technical trial reports
• Archive study documentation and correspondence
• Prepare final reports and occasionally manuscripts for publication

Qualifications

• University degree in scientific discipline or health care
• 2-3 years experience in healthcare industry, and/or clinical trials environment preferred
• Very good computer skills including MS Office
• Organisational, time management and problem-solving skills
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients

Organization: Taskimpetus Inc.

Industry: Healthcare

Benefits

• Increment would be at least a minimum of 15% every six months.
• Relocation charges will be provided to you during your project
• Medicinal, Dental and Vision benefits following 60 days of business.
• Medical coverage qualified following 60 days of business.
• Present moment and long-haul handicap following 60 days of work.
• 401k retirement benefits plan qualified following half a year of work.

Other Benefits

• Pre-job Training with Experienced Trainers.
• Assignments & Case Studies provided during training.
• Mock sessions before interviews
• Multiple interview rounds with different clients.
• Visa Sponsorship
• Training completing certificates