Clinical Research

Published: May 22, 2025 – The Clinical Research Professional conducts and manages clinical trials to ensure compliance with regulatory guidelines and ethical standards. This position analyzes clinical data to evaluate treatment efficacy and monitor patient safety throughout the study. The individual also collaborates with cross-functional teams to develop protocols, submit documentation, and oversee study timelines.

A Review of Professional Skills and Functions for Clinical Research

1. Clinical Research Assistant Functions

• Protocol Documentation: Maintains current and accurate protocol documentation and notifies appropriate individuals of pertinent protocol changes.
• Issue Communication: Identifies and communicates important protocol and data management issues to appropriate individuals.
• Patient Registration: Verifies that patients have completed appropriate registration materials and maintains related records and information.
• Volunteer Instruction: Instructs volunteers on protocol requirements and explains procedures and consent forms.
• Documentation Completion: Ensures related documentation is properly completed.
• Protocol Compliance Monitoring: Ensures protocol compliance with intense monitoring of specific study requirements and schedules protocol-related treatment and tests.
• Clinical Duties: Performs specific clinical duties per the research study.
• Supply Management: Assists in ordering and maintaining research supplies.
• Documentation Maintenance: Prepares and maintains a variety of documentation in the assigned area of responsibility.
• Specimen Handling: Serves as a backup, collecting and delivering specimens for analysis using appropriate or specified equipment.
• Labeling and Form Completion: Ensures proper labeling and obtains pertinent clinical and protocol information on request forms.
• Patient Interaction: Frequently interacts with patients, families, visitors, physicians, and related clinical departments.

2. Clinical Research Associate Responsibilities

• Trial Management: Participate in trial feasibility process, start-up activities, initiation, monitoring, and closeout activities
• Project Responsibility: Take responsibility for specific tasks on projects, or act as the main contact on individual projects, if applicable
• Document Creation: Create and distribute study documents
• Supply Management: Initial and ongoing IMP and/or other study supplies management
• System Updating: Update relevant tracking systems on an ongoing basis
• Staff Records Maintenance: Maintain the site staff details
• Data Review: Perform regular reviews of data per data review/monitoring guidelines (e.g., CTMS, EDC, IVRS, etc.)
• Document Collection: Collect updated/amended regulatory/essential documents in collaboration with CRA II, CRA III, SCRA, or Regulatory Officer (RO)
• Recruitment Monitoring: Review the recruitment plan and enrolment updates
• Data Follow-up: Follow up with site personnel on data entry, query status, and SAEs
• Site Communication: Follow up on appropriate site-related questions
• Trip Reporting: Prepare accurate and timely trip reports
• Site Management: Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment, and understanding of study requirements
• Risk Escalation: Identifying and escalating potential risks and identifying retraining opportunities for site personnel
• CAPA Management: Prepare corrective and preventive (CAPA) plans for issues identified during monitoring activities and proactive follow-up of each CAPA until timely resolution
• File Maintenance: Maintain the study files and ensure that files are up-to-date and accurate

3. Clinical Research Manager Job Description

• Trial Conduct Management: Manage activities related to the conduct of pharmaceutical, biotechnology and medical device clinical trials.
• Regulatory Document Management: Manage and provide support services for the collection, review, maintenance and tracking of regulatory documents from clinical sites.
• Site Training Management: Manage the training of potential investigative sites
• Site Selection Management: Manage the site/investigator selection system/process.
• Site Support Coordination: Provide centralized site support, communication and coordination to assure accurate and timely completion of all contracted activities.
• Site Management Support: Provide ongoing site management support through project completion.
• Clinical Research Knowledge: Understand clinical trials research through exposure to research protocols in a variety of therapeutic areas.
• Regulatory Knowledge: Know internal SOPs, FDA/ICH guidelines, and GCPs.
• Communication Facilitation: Facilitate general communication among the research centers, Baim project teams, sponsors and site monitors relative to the responsibilities itemized above.
• Staff Management: Manage assigned staff to perform their responsibilities within established project budgets and the department’s established operating metrics.

4. Clinical Research Nurse Duties

• Adverse Event Documentation: Responsible for writing up adverse events experienced by patients
• ISR Sheet Completion: Fill out the ISR sheets for patients taking part in the clinical study
• Clinical Procedures: Perform study-related activities such as cannulation, telemetry, holters, vital signs, and ECGs
• Participant Welfare: Ensure that the dignity, health, safety, and welfare of participants are given the highest priority at all times
• Clinical Judgment: Utilize skills, knowledge, nursing diagnosis, and clinical judgment to provide a high standard of care for participants in clinical trials
• Nursing Assessment: Utilize nursing assessment skills to observe participants\’ general well-being and potential adverse events, document adverse events and take appropriate action
• Informed Consent Process: Obtain Informed Consent and continue the ICF process by educating, explaining, and informing participants of study procedures
• Sample Collection: Collect and process biological samples according to the protocol and Standard Operating Procedures
• Data Recording: Record data obtained in a timely, error-free manner according to the protocol and Standard Operating Procedures
• Regulatory Knowledge: Maintain an understanding of current regulatory requirements
• Data Transcription: Transcribe source data onto the Case Report Form
• Data Quality Control: Take responsibility for the quality control of study data
• Professional Conduct: Apply NMC code and conduct to all aspects of duties (Leeds)

5. Clinical Research Nurse Practitioner Overview

• Informed Consent Verification: Ensure informed Consent has been obtained before performing any study procedures
• Screening Review: Review screening documentation and approve subjects for admission into the study, in discussion with the Primary Investigator
• Findings Documentation: Document all findings in subject-specific source documents
• Subject Assessment: Provide ongoing assessments of study subjects, including any potential Adverse Events or Serious Adverse Events, and ensure proper reporting and documentation of such events
• Clinical Examination: Perform assessments and physical examinations as part of clinical study procedures
• Adverse Event Management: Provide medical management of Adverse Events
• Sponsor Communication: Communicate with Sponsors
• PI Coverage: Provide coverage for the Primary Investigator

6. Clinical Research Specialist Role Purpose

• Scientific Support: Serve as an active member of study teams and provide scientific support to justify trial design and ongoing scientific analysis during protocol development
• Pre-Protocol Documentation: Generate pre-protocol documentation of scientific information
• Document Generation: Generate study-related documents, including reports of prior investigational, investigational brochures, protocols, informed consent forms, and case report forms
• Literature Synthesis: Synthesize literature and competitive information for trial designs and results for the assigned therapeutic area
• Statistical Plan Review: Review and critically analyze statistical analysis plans
• Data Set Analysis: Review and critically analyze data sets
• Publication Planning: Lead study-level publication planning, including manuscript writing and submission
• Publication Coordination: Lead publications for clinical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts
• Regulatory Documentation: Generate documents to support regulatory submissions and/or respond to questions from regulatory authorities about existing submissions

7. Clinical Research Specialist Job Summary

• Safety Maintenance: Maintaining an environment of safety for patients, self, and others
• Protocol Review: Reviewing research protocols to determine availability of resources, subjects, and equipment needs
• Patient Education: Educating patients and families about clinical trials, potential benefits, and goals of clinical research
• Team Communication: Communicating with physicians and other staff concerning protocols that are open to enrollment
• Informed Consent: Obtaining written informed consent with appropriate HIPAA authorization from each patient before study enrollment
• Study Conduct: Conducting studies as outlined by protocols
• Regulatory Compliance: Following established guidelines in the collection of data and ensuring regulatory compliance for each study, by following IRB policies and procedures, study requirements, federal regulations, etc.
• Audit Participation: Participating in sponsor audits and/or regulatory inspections of records and documents (e.g., FDA, CLGB/NSABP)
• Evidence-Based Practice: Recognizing, supporting, and utilizing evidence-based nursing practices

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