Lead Clinical Research Nurse

2 weeks ago

Baltimore, Maryland, United States InsideHigherEd Full time

Position Overview

We are looking for a Lead Clinical Research Nurse who will report directly to the Principal Investigator(s). This role is pivotal in overseeing the coordination and execution of designated clinical trials within the Genitourinary Disease Group.


Key Responsibilities


Project Management

  • Anticipate research needs for specific patient demographics.
  • Assist in the formulation and documentation of protocols and consent forms as necessary.
  • Collaborate in the creation and submission of regulatory documents as required.
  • Utilize expertise in study design to assess new protocols.
  • Apply knowledge of federal and local regulations in protocol evaluations.
  • Review and evaluate new protocols for clarity, thoroughness, and logistical feasibility while ensuring participant safety.
  • Assess resource availability and impact for assigned clinical trials.
  • Identify and communicate concerns regarding new protocols with the Principal Investigator and/or sponsor.
  • Suggest and negotiate modifications to enhance protocol implementation.

Pre-Initiation

  • Work with the team to define roles and responsibilities for healthcare professionals involved in trial implementation.
  • Collaborate in designing effective data collection methods for assigned trials.
  • Oversee the development of study tools, including data collection forms and eligibility checklists.
  • Ensure the protocol is reviewed by the pharmacy for input as needed.
  • Guarantee compliance with local and national regulatory standards.
  • Coordinate with the study team and pharmacy to prepare drug data sheets for new trials.
  • Confirm that Institutional Review Board (IRB) approval is obtained before commencing research activities.
  • Represent the department in research and protocol initiation meetings.
  • Ensure all trial elements are ready prior to participant recruitment.
  • Communicate with protocol sponsors and coordinate plans to address any issues with the Principal Investigator.

Recruitment & Enrollment

  • Ensure ongoing eligibility of all participants in assigned research studies.
  • Collaborate in developing recruitment strategies to meet patient enrollment targets within protocol timelines.

Data Collection & Document Management

  • Ensure the collection of relevant data from various sources and monitor compliance with trial requirements.
  • Apply pharmacological knowledge to assist in evaluating adverse events related to study drugs or procedures.
  • Manage patient care in clinical studies while adhering to all protocol requirements and standard clinical practices.
  • Ensure all clinical protocol deviations are communicated for proper documentation and regulatory submission.
  • Demonstrate the ability to manage multiple projects at various stages of the clinical research process.
  • Integrate new clinical trials with ongoing research activities.

Quality Assurance

  • Evaluate clinical trial outcomes.
  • Monitor compliance with required study procedures and Good Clinical Practice (GCP) standards.
  • Conduct ongoing data analysis regarding clinical research studies, including adverse reactions and responses.
  • Participate in institutional quality assurance processes.
  • Engage in audits and monitoring by sponsors or cooperative groups.
  • Assist in the development and review of institutional Standard Operating Procedures (SOPs) related to clinical research.
  • Maintain comprehensive records of correspondence and submissions to regulatory bodies.

Education & Training

  • Provide initial and ongoing education to patients and families regarding clinical trials and management issues.
  • Participate in the orientation of new Clinical Research Nurses and Clinical Associates, including mentoring.
  • Coordinate and present continuing education programs for clinical staff as appropriate.
  • Engage in professional development through workshops and conferences.

Community Engagement

  • Collaborate with the research team to prepare study results for publication and presentation.
  • Contribute to manuscripts for publication in nursing literature and presentations at conferences.
  • Identify nursing research questions related to protocol populations and implement studies as departmental priorities allow.
  • Seize opportunities to present research projects to the local community.

Clinical Responsibilities

  • Identify needs and incorporate interdisciplinary information into clinical research protocols.
  • Plan long-term patient care in relation to assigned research protocols.
  • Collaborate with the healthcare team to facilitate protocol requirements for clinical trials.
  • Evaluate the effectiveness of nursing care provided.
  • Assess patient responses to interventions and propose alternative methods as needed.

Supervisory Responsibilities

  • Provide oversight of Clinical Associates as assigned.

Working Conditions

  • Potential exposure to communicable diseases and hazardous materials; safety regulations must be adhered to.
  • Work schedules may require flexibility and extended hours based on protocol activities.

Minimum Qualifications

  • Registered nurse with a valid license in the state of practice. A Bachelor's degree in nursing or a related field is required.
  • A Master's degree is strongly preferred.
  • At least two years of experience in the specialty or a related area is required.
  • Additional experience may substitute for educational requirements on a case-by-case basis.

This position offers a competitive salary and benefits package, supporting the health, life, career, and retirement of our employees.

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