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.