Research Associate I (JR231784)

ViziRecruiter,LLC.; New York (NY); On-site; USD 60,000 - 75,000; Full time

Job summary

The Research Associate I will oversee multiple clinical trials, serving as a point person for patients, family members, and the clinical study team. The role involves coordinating across hospital departments to ensure completion of trial-related activities and adherence to regulatory requirements.

They will prepare protocol submissions, assist with patient billing in EMR systems, and lead workflow development for trial tasks.

Qualifications

• Bachelor's degree required.
• GCP training required.
• A record of clinical research.
• Publication from prior research work.
• MS Office proficient.
• Excellent written and oral communication skills.
• Exceptional attention to detail and accuracy.
• Ability to manage multiple tasks & priorities.
• Demonstrated leadership potential.
• Knowledge of concepts, practices and procedures in related field.

Responsibilities

• Direct daily trial activities including data entry, consent and recruitment and clinical assessments.
• Ensure adherence to study protocols and regulatory requirements.
• Develop workflows for clinical trials and reminders/updates to the team.
• Coordinate team members to complete clinical and non-clinical assessments per protocol.
• Prepare and submits protocol applications, amendments and informed consent documents for IRB review.
• Execute patient billing in multiple databases including EMR.
• Develop action plans to ensure all study tasks are completed per protocol.
• Coordinate monitoring and auditing visits with study personnel and auditors.
• Train to manage clinical trial projects independently after sufficient training.

Skills

MS Office proficient

Excellent written and oral comms

Attention to detail

Leadership potential

Education

Bachelor's Degree

Job description

Introduction

To heal, to teach, to discover and to advance the health of the communities we serve.

Overview

TheResearch Associate Iwill oversee multiple clinical trials, serving as a point person for patients, their family members, and the clinical study team. The position consists of working with various departments across the hospital, including forging new partnerships with departments to ensure completion of trial-related activities. The clinical research coordinator I will direct participants and study team members to adhere to the study protocol and rules and regulations governed by regulatory bodies including Institutional Review Boards and the FDA.

Responsibilities

• Directing seamless flow of daily trial-related activities, including data entry, consent and recruitment and clinical assessments as required by the study protocol of the study subjects.
• Directing strict adherence to the study protocols, as well as sponsor, FDA and other regulatory authority requirements.
• Developing workflows for clinical trial, including reminders/updates to the clinical team.
• Coordinating team members to complete both clinical and non-clinical assessments per protocol. This includes developing workflow for patient care such as assigning secretaries to schedule patients, developing workflow with ancillary departments (such as radiology, advanced imaging, pathology, pharmacy), and assigning appropriate clinical team members such as doctors to complete clinical tasks such as reviewing adverse events versus assigning non-clinical team members to complete non-clinical tasks such as administering questionnaires to a patient.
• Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for IRB review and approval.
• Executing patient billing in multiple databases including the patient’s electronic medical record.
• Developing action plans for ensuring all study tasks are completed as required per the protocol and developing subsequent corrective action plans if any errors are made.
• Coordinates assigned study monitoring and auditing visits with study coordinator, investigator, industry sponsors, and internal/external auditors.
• The Research Associate I will be trained to be highly specialized in clinical trials assigned to them and is expected to be able to manage clinical trial projects independently after sufficient training is completed

Requirements

• Bachelors Degree required
• GCP training required
• A record of clinical research
• Publication from prior research work
• MS Office proficient.
• Excellent written and oral communication skills
• Exceptional attention to detail and accuracy
• Ability to manage multiple tasks & priorities
• Demonstrated leadership potential
• Knowledge of variety of concepts, practices and procedures in directly related field