Research Associate

Montefiore Health System•New York, NY

1d•Onsite

About The Position

The Research Associate will 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.

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

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 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.