Research Associate I

Montefiore Health System; New York (NY); On-site; USD 53,000 - 66,000; Full time

Job summary

Montefiore Medical Center in Bronx, NY is seeking a Research Associate I to oversee multiple clinical trials, serving as primary contact for patients and study teams. You will coordinate cross-department activities and ensure adherence to protocols and regulatory requirements.

The role involves data entry, consent, recruitment, adverse event review, and collaboration with radiology, pathology, pharmacy, and other units.

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 variety of concepts, practices and procedures in directly related field.

Responsibilities

• Direct daily trial activities including data entry, consent, recruitment and clinical assessments as required by the study protocol.
• Directing strict adherence to the study protocols, 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, including coordinating with radiology, pathology, pharmacy and assigning appropriate clinical staff.
• 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 per the protocol and devising corrective actions.
• Coordinates 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

Skills

Written and oral communication

Attention to detail

Multitasking

Leadership potential

Regulatory knowledge

Education

Bachelor's Degree

Tools

MS Office

Job description

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-$66,300.00

The 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

Montefiore Medical Center is an equal employment opportunity employer. Montefiore Medical Center will recruit, hire, train, transfer, promote, layoff and discharge associates in all job classifications without regard to their race, color, religion, creed, national origin, alienage or citizenship status, age, gender, actual or presumed disability, history of disability, sexual orientation, gender identity, gender expression, genetic predisposition or carrier status, pregnancy, military status, marital status, or partnership status, or any other characteristic protected by law.