Research Associate I

3000 Montefiore Medical Center; Providence (RI); On-site; USD 53,000 - 66,000; Full time

Job summary

Montefiore Medical Center in Bronx, NY seeks a Research Associate I to oversee multiple clinical trials, coordinating with patients, families and the study team. You will work across departments to ensure trial activities meet regulatory requirements and protocol standards.

After training, you may manage projects independently, directing data entry, consent, recruitment and adverse event reviews, with emphasis on accuracy and timely documentation in electronic medical records.

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

• Directing seamless flow of daily trial-related activities, including data entry, consent and recruitment and clinical assessments as required by the study protocol.
• 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.
• 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.

Skills

GCP training

Excellent written and oral comms

Attention to detail

Ability to manage multiple tasks

Demonstrated leadership potential

Publication from prior research

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.

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.

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.

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.

Since its inception in 1884, Montefiore’s mission has been to heal, to teach, to discover and advance the health of the communities we serve. Montefiore's state-of-the-art facilities include the internationally-recognized Children’s Hospital at Montefiore and our Notable Centers of Excellence - Montefiore Einstein Center for Cancer Care, Montefiore Einstein Center for Heart and Vascular Care, Montefiore Einstein Center for Transplantation. Combined with a growing number of locations for primary and specialty care throughout the Bronx and Westchester County, Montefiore is the ideal organization to apply and hone your expertise.

An assortment of insurance products and discount programs through Voluntary Benefits. Check out our comprehensive benefits available to you when you join our outstanding team! To heal, to teach, to discover and to advance the health of the communities we serve. To be a premier academic medical center that transforms health and enriches lives.