Jobs · Analyst · New York

Sr. Clinical Research Coordinator

Actalent · Bronx, NY · 1 wk ago
HybridAnalyst$80k–$85k/yrFull-time

About the role

The Clinical Research Coordinator plays a key role in supporting oncology clinical trials by coordinating protocol initiation and activation, managing study documentation, and ensuring accurate data collection and reporting. This position combines hands-on work with patients in a clinic setting and robust data management responsibilities, contributing directly to high-quality, compliant cancer research.

Responsibilities

  • Cover the initiation and activation of new clinical trial protocols in accordance with institutional and regulatory requirements.
  • Prepare and organize study tools such as study binders, medication diaries, eligibility checklists, calendars, and flow sheets to support protocol execution.
  • Use Oncore®, Excel®, and Word to develop and maintain study tools and documentation needed for each clinical trial.
  • Review patients’ charts and medical histories in collaboration with the Research Nurse Clinician and/or physician to confirm protocol eligibility and obtain necessary source documents.
  • Ensure that IRB-approved informed consent forms are properly obtained, signed, filed in the medical record, and that copies are provided to patients.
  • Maintain complete and accurate research records for all enrolled patients, including consent forms, eligibility documentation, case report forms (CRFs), registration confirmations, and corresponding source documents.
  • Assist the Research Nurse Clinician and physician in grading adverse events using the most recent National Cancer Institute (NCI) common toxicity criteria or protocol-specific grading scales.
  • Complete Serious/Unexpected Adverse Event (SAE) forms for internal and multicenter serious or unexpected adverse events as required by study sponsors, federal regulations, and institutional guidelines.
  • Provide regular Oncore®-based reports to tumor study group members and Principal Investigators for all assigned studies.
  • Serve as a primary liaison with study sponsors, scheduling monitoring visits and conference calls, and providing accurate, timely, and well-informed responses to sponsor queries.
  • Perform robust data management and coordination activities, including data collection, data entry, and ongoing data quality review across multiple electronic data capture (EDC) systems.
  • Recruit, screen, and consent patients for clinical trials, ensuring that eligibility criteria are met and that patients understand the study requirements.
  • Work in a clinic setting to support approximately 40% of responsibilities focused on patient-facing activities for oncology trials.
  • Conduct blood processing as required by study protocols, following established procedures and safety standards.

Requirements

  • Minimum of a bachelor’s degree.
  • At least 4 years of clinical research experience, including patient recruitment, data collection, and data entry.
  • At least 4 years of oncology experience, which may come from clinical research, academic training, or nursing roles, including gynecologic oncology.
  • Demonstrated experience recruiting, screening, and consenting patients for clinical trials.
  • Strong background in data management, with approximately 60% of responsibilities focused on data management and coordination.
  • Experience working with multiple electronic data capture (EDC) systems; Medidata and Inform are highly preferred.
  • Proficiency using Oncore®, Excel®, and Word to create and manage study tools and documentation.
  • Experience with blood processing in a clinical or research environment.
  • Knowledge of adverse event grading using NCI common toxicity criteria or protocol-specific scales.
  • Ability to maintain accurate, complete research records and case report forms in compliance with regulatory and institutional standards.

Qualifications

  • OncoLOGY experience that may be gained in settings such as school, nursing, or gynecologic oncology groups.
  • Familiarity with institutional review board (IRB) processes and informed consent requirements.
  • Strong organizational skills and attention to detail for managing multiple studies and data systems simultaneously.
  • Effective communication skills for interacting with physicians, research nurses, study sponsors, and patients.
  • Ability to anticipate sponsor needs and provide timely, well-reasoned responses to queries.
  • Comfort working both independently and collaboratively within multidisciplinary tumor study groups.

Skills

  • Strong background in data management, with approximately 60% of responsibilities focused on data management and coordination.
  • Experience working with multiple electronic data capture (EDC) systems; Medidata and Inform are highly preferred.
  • Proficiency using Oncore®, Excel®, and Word to create and manage study tools and documentation.
  • Experience with blood processing in a clinical or research environment.
  • Knowledge of adverse event grading using NCI common toxicity criteria or protocol-specific scales.

Benefits

Montfiore perm benefits that they give all perm employees.

Pay and Benefits

The pay range for this position is $80000.00 - $85000.00/yr.

Workplace Type

This is a hybrid position in bronx,NY.

Application Deadline

This position is anticipated to close on Jul 17, 2026.

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