Research Associate I

Montefiore New Rochelle; New York (NY); Vor Ort; USD 53.040 - 66.300; Vollzeit

Zusammenfassung

Montefiore New Rochelle seeks a Research Associate I to oversee multiple clinical trials, acting as a primary contact for patients and study teams. The role involves coordinating with multiple departments to ensure timely completion of trial activities and adherence to study protocols under IRB and FDA regulations.

The candidate will develop trial workflows, manage data entry and patient consent, and supervise staff to execute clinical and non-clinical tasks.

Qualifikationen

• Bachelor's degree required.
• GCP training required.
• Experience in clinical research preferred.
• Publication from prior research work considered a plus.

Aufgaben

• Direct daily trial-related activities including data entry, consent, recruitment and clinical assessments.
• Ensure strict adherence to study protocols and regulatory requirements (IRB, FDA).
• Develop workflows for clinical trials and reminders for the team.
• Coordinate team members to complete clinical and non-clinical assessments per protocol.
• Prepare and submit protocol applications, amendments, continuing reviews, and informed consent documents for IRB review.
• Manage patient billing in multiple databases and EMR systems.
• Plan corrective actions to address protocol deviations and improve study tasks.
• Coordinate monitoring and auditing visits with sponsors and auditors.

Kenntnisse

MS Office

Written and verbal communication

Attention to detail

Leadership potential

Multitasking

Time management

Ausbildung

Bachelor's degree

Tools

MS Office

Jobbeschreibung

## Research Associate IApplylocations: 3319 Rochambeau Avenuetime type: Full timeposted on: Posted Todayjob requisition id: JR231784**City/State:**Bronx, New York**Grant Funded:**Yes**Department:**Card-research Administration**Work Shift:**Day**Work Days:**MON-FRI**Scheduled Hours:**8:30 AM-5 PM**Scheduled Daily Hours:**7.5 HOURS**Pay Range:**$53,040.00-$66,300.00The **Research Associate I** 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.**Job 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**QUALIFICATIONS:* 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