Clinical Research Nurse

Actalent; New Jersey; On-site; USD 85,000 - 120,000; Full time

Job summary

Actalent in New Jersey is seeking a Clinical Research Nurse Coordinator to oversee oncology trial operations, ensuring protocol compliance and coordinating among investigators, nurses, regulatory staff, and patients.

You will support trial feasibility, regulatory submissions, patient recruitment and education, and maintain accurate documentation across EMR, CTMS, and databases.

The role requires skilled nursing assessments, HIPAA understanding, and effective collaboration to advance study goals.

Qualifications

• Regulatory knowledge for oncology trials and protocol changes.
• Informed consent processes and HIPAA/privacy requirements.
• IRB submission and continuing review handling.
• Budget planning and cost analyses for trials.

Responsibilities

• Act as liaison among investigators, nurses, and regulatory staff on regulatory issues and protocol changes.
• Collaborate to assess feasibility and competition before submission.
• Assist PI in preparing trial proposals, coordinating resources and documentation.
• Ensure protocol revisions, consents, and adverse events are submitted to IRB in a timely manner.
• Develop budgets with investigators and budget coordinator.
• Recruit and evaluate potential patients; coordinate appointments and interviews.
• Tailor patient care to diverse populations and communicate at appropriate literacy levels.
• Review medical records to ensure complete documentation per protocol.

Skills

Regulatory compliance

Informed consent

IRB submissions

Budget development

Patient recruitment

Clinical trial coordination

HIPAA compliance

Nursing assessments

Tools

EMR systems

CTMS

Budgeting tools

Job description

Job Description

Job Description

Job Title: Clinical Research Nurse Coordinator

Job Description

The Clinical Research Nurse Coordinator oversees and coordinates the clinical operations of assigned oncology clinical trials, ensuring compliant study conduct in alignment with local, federal, and state regulations and institutional policies. This role serves as a key liaison among principal investigators, sub-investigators, clinical research nurses, regulatory specialists, and study patients, supporting trial feasibility, regulatory submissions, patient recruitment and education, and accurate documentation of all study-related activities.

Responsibilities

• Act as a primary liaison between principal investigators, sub-investigators, clinical research nurses, and regulatory specialists on all regulatory issues and protocol changes.
• Collaborate with principal investigators, clinical research coordinators, and the clinical team to review studies for feasibility and evaluate potential competition with other protocols prior to submission.
• Assist principal investigators in preparing proposed clinical trials by reviewing trial protocols, contacting departments that will provide study resources, and ensuring appropriate departments are notified and receive trial documentation, including scientific merit and accrual potential.
• Ensure all protocol revisions, informed consents, continuing reviews, and serious adverse events are submitted to the appropriate Institutional Review Board (IRB) of record in a timely manner.
• Review studies with principal investigators and/or clinical research coordinators to develop budgets that outline standard-of-care and research costs, and finalize budget drafts with the budget coordinator.
• Recruit and evaluate potential study patients and work with clinical research coordinators to schedule required appointments and interviews.
• Identify the needs of the patient population served and tailor care to those needs, including age, culture, and sensory impairments, communicating with patients, parents, and caregivers at an appropriate developmental, educational, and literacy level.
• Review medical records for potential study patients and ensure records include complete documentation of laboratory test results, procedures, and progress, following protocol sponsor guidelines.
• Instruct potential study patients, designated caregivers, physicians, nurse clinicians, and ancillary staff on aspects of patient care, available trials, treatments, and possible side effects.
• Assist investigators with the informed consent process, ensuring study patients understand clinical trials and obtaining written informed consent.
• Educate study patients regarding informed consent procedures and HIPAA authorization requirements.
• Document study patients’ medical histories, including past medical and surgical treatments, significant medical conditions, and medication histories, in accordance with protocol guidelines.
• Perform nursing assessments and monitor study patients’ progress during clinical trials, tracking responses using toxicity flow sheets, medication flow sheets, and nursing progress notes.
• Maintain accurate, complete, and up-to-date records on each patient participating in clinical trial protocols across all applicable systems, including electronic medical records, clinical trial management systems, departmental databases, and protocol-specific databases.
• Evaluate and develop study patient education materials and provide instructions to patients and caregivers on drug administration and other medical information, including creating study-specific calendars.
• Plan appropriate patient care under the direction of a physician or advanced practice nurse to support clinical trial requirements.
• Notify principal investigators of any adverse events and serious adverse events, including evidence of drug toxicity or unexpected side effects.
• Report all serious adverse events to study sponsors and IRBs of record according to established timelines and regulatory requirements.
• Coordinate research activities, including scheduling laboratory tests, radiology exams, and other medical procedures required by the protocol.
• Perform and/or oversee clinical duties such as EKGs and processing and shipping blood serum and urine samples, and communicate results to principal investigators and advanced practice nurses.
• Review and process safety reports (including IND safety reports and other sponsor safety communications) together with the principal investigator, following institutional policies and procedures.
• Act as the principal investigator’s representative when appropriate, including communicating with sponsors and their representatives, the IRB, and other med