Clinical Research Coordinator(Data)

Actalent; United States; Hybride; USD 34 000 - 48 000; Plein temps

Avantages offerts par ce poste

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

Health Savings Account (HSA)

Transit benefits

Employee Assistance Program

Paid Time Off

Résumé du poste

Actalent is seeking an experienced Clinical Research Data Coordinator in Bronx, NY to support oncology trials from initiation through data management. You will prepare study tools, review patient histories, and ensure source documentation aligns with protocol requirements.

The role emphasizes data entry, query resolution, and SAE/AE reporting using Oncore and MS Office tools, with hybrid, contract work from Bronx location.

Qualifications

• 12+ years as a Clinical Research Coordinator with data entry and query resolution focus in oncology trials.
• Extensive oncology clinical research experience, preferably in an NCI-designated setting.
• Experience screening, enrolling and consenting patients per protocols.
• Experience with AE/SAE reporting and regulatory communications.
• Proficient in Oncore for trial management; skilled in Excel/Word for study tools.

Responsabilités

• Coordinate initiation and activation of new oncology trial protocols.
• Prepare study tools and binders aligned with protocol requirements.
• Develop and update study tools using Oncore, Excel, and Word.
• Review charts and medical history to confirm eligibility and obtain source documents.
• Ensure IRB-approved consent forms are obtained, filed, and provided to patients.
• Maintain complete research records including CRFs and source documents.
• Assist in grading adverse events using NCI toxicity criteria.
• Complete SAE forms per sponsor, federal regulations, and institutional guidelines.
• Provide status reports to tumor study groups and Principal Investigators on enrollment and data.
• Coordinate sponsor communications and monitoring visits.
• Support screening, enrolling, and consenting per protocols; coordinate medication-related activities.
• Focus on data entry and query resolution; ensure data quality and timelines.
• Support onboarding and training of new coordinators.

Connaissances

Data entry focus on oncology trials

Query resolution

Oncology clinical research

Adverse event reporting

Trial documentation

Oncore proficiency

Excel proficiency

Word proficiency

Outils

Oncore

Excel

Word

Description du poste

Clinical Research Data Coordinator

Responsibilities

• Coordinate the initiation and activation of new oncology clinical trial protocols, ensuring all required elements are in place before enrollment begins.
• Prepare and maintain study tools, including study binders, medication diaries, eligibility checklists, calendars, and flow sheets, ensuring they align with protocol requirements.
• Use Oncore, Excel, and Word to develop and update study tools and documentation needed for effective trial conduct and data collection.
• Collaborate with Research Nurse Clinicians and physicians to review patient charts and medical history to confirm protocol eligibility and obtain necessary source documents.
• Ensure that Institutional Review Board (IRB) approved informed consent forms are properly obtained, signed, filed in the medical record, and that copies are provided to patients under the direction of the Research Nurse Clinician and/or physician.
• Maintain complete and accurate research records for all enrolled patients, including informed consent documentation, eligibility confirmation, Case Report Forms, registration confirmations, and all corresponding source documents.
• Assist Research Nurse Clinicians and physicians in grading adverse events using the most recent National Cancer Institute common toxicity criteria or protocol-specific grading scales.
• Complete Serious and Unexpected Adverse Event (SAE) forms for internal and multicenter serious or unexpected adverse events in accordance with sponsor requirements, federal regulations, and institutional guidelines.
• Provide regular status reports using Oncore to tumor study group members and Principal Investigators on all assigned studies, including enrollment, data status, and outstanding queries.
• Serve as a liaison with study sponsors by understanding and anticipating sponsor needs, scheduling monitoring visits and conference calls, and providing accurate, timely, and well-supported responses to sponsor queries.
• Support screening, enrolling, and consenting patients into research studies based on study protocols, ensuring adherence to eligibility criteria and regulatory requirements.
• Coordinate medication-related activities for patients on study as required by protocol and institutional procedures.
• Focus on data entry and query resolution for oncology trials, ensuring data quality, completeness, and adherence to timelines.
• Support onboarding and training of new Clinical Research Coordinators by sharing best practices and assisting with supervision as needed.

Essential Skills

• 12 years of experience as a Clinical Research Coordinator with a primary focus on data entry and query resolution for oncology trials.
• 12 years of oncology clinical research experience, preferably within an NCI-designated cancer setting or similar oncology research environment.
• Experience screening, enrolling, and consenting patients into research studies based on study protocols.
• Experience with adverse event reporting, including identification, documentation, and communication of AEs and SAEs.
• Proficiency using Oncore for clinical trial management and reporting.
• Proficiency with Microsoft Excel and Word for creating and maintaining study tools and documentation.

Job Type & Location

This is a Contract position based out of bronx, NY.

Pay and Benefits

The pay range for this position is $25.00 - $35.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract position based out of bronx, NY.

Application Deadline

This position is anticipated to close on Nov 16, 2026.

Workplace Type

This is a hybrid position in bronx,NY.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.