CLINICAL RESEARCH COORDINATOR JOB DESCRIPTION

A Clinical Research Coordinator runs the operational layer of a clinical trial. Without this role, GCP-compliant documentation goes unmaintained, adverse event reporting falls behind regulatory deadlines, and sponsor audits expose the site to findings that can pause or terminate a study. The coordinator owns participant-facing execution - from informed consent through final visit - while simultaneously managing IRB submissions, regulatory binders, and data query resolution. Few roles in a research site carry accountability across both patient contact and regulatory compliance at once.

As the Clinical Research Coordinator, you ensure that assigned clinical trials run on schedule, within protocol, and in full compliance with applicable GCP guidelines and institutional requirements. Day-to-day scope spans participant recruitment and study visit execution through to sponsor communication and site close-out, working alongside Principal Investigators and cross-functional departments.

Career Impact: Coordinating multi-phase trials under GCP frameworks builds a verifiable compliance and protocol management record that is directly transferable to senior CRC, CRA, or study management roles.

Business Impact: Accurate adverse event reporting and timely data query resolution determine whether a trial site retains sponsor confidence and remains active through study completion.

Growth Opportunity: Exposure to investigator-initiated protocols, IRB processes, and audit preparation expands competency toward Clinical Research Associate or Trial Manager positions within a few years.

Company Value: Positions in this network span oncology, neurology, cardiovascular medicine, and other specialty areas, offering coordinators genuine breadth of therapeutic exposure across a career.

• Recruit, screen, and enroll research participants in accordance with protocol eligibility criteria and GCP requirements.
• Conduct study visits including baseline, treatment, and follow-up assessments, and perform required clinical procedures such as phlebotomy, ECG, and vital signs collection.
• Maintain regulatory binders, source documentation, and study files to ensure audit-ready compliance throughout each trial.
• Identify, document, and report adverse events and protocol deviations to investigators and sponsors within required timeframes.
• Coordinate IRB submissions, informed consent processes, and sponsor correspondence to support site initiation and ongoing trial governance.
• Collect, enter, and resolve queries in case report forms and electronic data capture systems to maintain data accuracy and completeness.
• Liaise with hospital departments, laboratory services, and third-party vendors to support scheduling and execution of protocol-required procedures.
• Prepare trial sites for monitoring visits, close-out activities, and regulatory inspections, including archiving of all study records.

• Bachelor's degree in a life sciences, health sciences, or nursing field, or equivalent clinical work experience.
• Two or more years of clinical research coordination experience, with direct involvement in GCP-compliant trial operations.
• Working knowledge of IRB submission processes, informed consent requirements, and federal research regulations.
• Demonstrated ability to perform clinical procedures including phlebotomy, ECG administration, and vital signs assessment.
• Competency in electronic data capture entry and data query resolution within clinical trial systems.
• Strong organizational skills with the ability to manage multiple active protocols simultaneously without loss of detail.
• Effective written and verbal communication skills for interaction with investigators, sponsors, participants, and regulatory bodies.

• ACRP or SoCRA Clinical Research Coordinator certification, or active progress toward credentialing.
• Experience in a specialty therapeutic area such as oncology, neurology, orthopedics, or cardiovascular medicine.
• Familiarity with investigator-initiated trial design and database development in a research site setting.
• Basic Life Support or Advanced Cardiac Life Support certification current at time of hire.

• Protocol deviation rate per active trial, reflecting adherence to study-specific procedures and GCP standards.
• Adverse event reporting turnaround in days, measuring compliance with sponsor and regulatory submission deadlines.
• Recruitment target attainment rate as a percentage of enrollment goals per trial per quarter.
• Data query resolution cycle time, tracking how quickly open queries in EDC systems are closed.
• Audit finding count per monitoring visit, reflecting regulatory binder completeness and source document accuracy.
• Typical tools: Electronic data capture platforms (commonly REDCap or similar EDC systems); regulatory document management (commonly trial master file software).

• Base Salary Range: $52,000 to $72,000 annually, depending on experience and location.
• Bonus: Annual performance bonus of 3 to 7 percent, where applicable by employer.
• Equity: Typically not offered at this level in clinical site roles.
• Health Benefits: Medical, dental, and vision coverage standard across most hospital and research site employers.
• PTO: 15 to 20 days annually, plus standard federal holidays.
• Common Perks: Continuing education support, GCP training reimbursement, and professional association membership.

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Drug screening and a thorough background check, which may include verification of clinical licensure and prior research conduct, are conditions of employment for this role given its patient-contact responsibilities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, and local law. Reasonable accommodations are available to individuals with disabilities throughout the application and employment process upon request. Candidates must hold current authorization to work in the United States.

The Clinical Research Coordinator owns the end-to-end operational management of assigned clinical trials - from regulatory binder setup and patient recruitment through study close-out and archiving - in support of the Clinical Research Lead and Investigators. Working directly with sponsor representatives, hospital departments, and trial participants, this coordinator ensures all research activity meets GCP Guidelines, study-specific protocols, and applicable national and international regulatory requirements.

Key Responsibilities

• Work with the Clinical Research Lead and Start Up Team to ensure the efficient and timely start-up of all research projects.
• Attend Pre-Study and Site Initiation Visits for allocated trials.
• Maintain a thorough understanding of all trials being conducted in the state, particularly the protocol, investigator brochure, participant information and consent forms, budget, timelines and safety reporting requirements.
• Establish and organise study files, including regulatory binders, study specific source documentation and other materials as required.
• Work with the Team Lead to develop and update patient recruitment plans and ensure recruitment targets and timelines are met.
• Work closely with the Team Lead and Investigators to manage day-to-day research activities.
• Liaise directly with patients to ensure awareness of all trial related requirements and attendance at all trial related appointments and assessments.
• Remain available to discuss any trial related queries with patients and liaise with investigators to ensure all questions and concerns are addressed.
• Schedule protocol specific assessments and procedures ensuring Investigators are available during study visits to perform required tasks.
• Liaise with and facilitate collaboration between relevant hospital departments and third parties to ensure the provision of quality clinical services.
• Prepare for and host pre-study, site initiation, monitoring and close out visits.
• Maintain all study related documentation and ensure data queries are completed in a timely manner.
• Complete all study close out activities including archiving of all study records.
• Maintain open and regular communication with key stakeholders, in particular sponsor representatives.
• Maintain up-to-date knowledge in regulatory, administrative and clinical frameworks and current clinical issues and practice as they pertain to research.
• Complete all tracking, reporting and mandatory training activities within required timelines.
• Ensure all research is conducted in accordance with GCP Guidelines, study specific protocols and all applicable national and international laws and regulations.

Required Qualifications

• Current AHPRA registration as a Registered Nurse.
• Minimum of 3 years of experience in nursing, with oncology or nuclear medicine experience highly desirable.
• Excellent nursing and observational skills.
• Phlebotomy experience and skills.
• Strong computer literacy with knowledge of clinical trials software and MS Office suite.
• Excellent communication and interpersonal skills.
• Ability to work both independently and as part of a team in a proactive and cooperative manner.
• High level of initiative and flexibility with the ability to meet deadlines while balancing multiple priorities.

Embedded within a multi-specialty clinical trials environment spanning areas including Gastroenterology, Neurology, Cardiovascular Medicine, and Psychiatry, the Clinical Research Coordinator independently coordinates complex research protocols in compliance with regulatory laws and institutional guidelines. Working closely with the principal investigator and departmental research teams, this coordinator manages participant screening and enrollment, adverse event reporting, and regulatory compliance to sustain study quality and data integrity across concurrent trials.

Core Functions

• Independently coordinate complex clinical research protocols with minimal direction from the principal investigator in compliance with regulatory laws and institutional guidelines.
• Collaborate with the research team to assess feasibility and management of research protocols.
• Screen, enroll, and recruit research participants.
• Coordinate schedules and monitor research activities and subject participation.
• Identify, review, and report adverse events, protocol deviations, and other unanticipated problems appropriately.
• Manage, monitor, and report research data to maintain quality and compliance.
• Provide education and training for others within the department.
• Perform administrative and regulatory duties related to the study as appropriate.
• Participate in protocol development activities and other assignments as assigned.

Qualifications & Experience

• HS Diploma with at least 7 years of clinical research coordination experience.
• Associate's degree with at least 2 years.
• Bachelor's degree with at least 1 year of relevant experience.
• Graduate or diploma from a study coordinator training program preferred.
• Medical terminology course preferred.

Reporting to the orthopedic service line research leadership, the Clinical Research Coordinator supports the full scope of patient-facing and regulatory functions across assigned clinical studies, including recruitment, protocol-required assessments, IRB documentation, and sponsor correspondence. Partnering with referring physicians, community agencies, and cross-departmental staff, this coordinator ensures protocol implementation is uniform, documentation is accurate and timely, and patients and families receive consistent educational support throughout their participation.

Primary Duties

• Provide study information and obtain relevant information to and from patients engaged in clinical studies, including assisting in recruitment and screening, registering patients, providing protocol information, obtaining medical history, collecting prior records, explaining procedures and consent forms, compiling information prior to initial visits, and updating databases.
• Perform tasks required by protocol, including obtaining patient medical history, systems review, phlebotomy, EKG, and cognitive assessment, and collect vital signs.
• Maintain quality assurance on designated protocols and collect and assist in interpreting data as required.
• Triage adverse events and communicate with the research physician regarding their occurrence, and collect information regarding indicated medical follow-up.
• Provide educational information to patients and their families and serve as a consistent point of contact within the clinical research program.
• Ensure uniform implementation of protocols by completing required documentation in a consistent, accurate and timely manner.
• Assist in preparing IRB forms, informed consents, and sponsor correspondence accurately and on time, and may participate in the annual IRB approval and update process.
• Serve as a liaison to other departments, programmatic areas, and community agencies.
• Ensure primary referring physicians receive timely progress notes on patient diagnosis and treatment.
• May assume primary responsibility for the implementation and management of new clinical trials.

Education & Experience

• Bachelor's degree in a healthcare field required.
• Working towards Clinical Research Coordinator Certification (CRCC).
• Two to four years of clinical research experience.
• Familiarity with medical and clinical terminology.
• Excellent organizational, task management, and communication skills.
• Ability to maintain confidentiality of patient and study information.
• Knowledge of federal and state regulations governing practice as well as applicable institutional policies and procedures.

Sitting at the intersection of clinical operations and data integrity, the Clinical Research Coordinator reviews and executes study protocols, manages regulatory and ethics documentation submissions, and performs complex clinical procedures including ECG, spirometry, and cardiac telemetry monitoring across assigned research projects. Operating across study teams, sponsor auditors, and regulatory inspection bodies, this coordinator supports investigator compliance, maintains source documentation, and ensures participant safety is monitored and reported in accordance with applicable quality standards.

Duties

• Review study protocols, Case Report Forms, other study-specific documents, and electronic data capture systems used to record clinical research data.
• Attend all relevant study meetings.
• Collect and submit regulatory and ethics documentation as required by relevant regulatory bodies governing the conduct of clinical research.
• Recruit and screen patients for clinical trials and maintain subject screening logs.
• Orient research subjects to the study, including purpose, procedures, and protocol issues such as timelines for visits.
• Design and maintain source documentation based on protocol requirements.
• Schedule and execute study visits and perform study procedures.
• Collect, record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness.
• Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics.
• Monitor subject safety and report adverse reactions to appropriate medical personnel.
• Correspond with research subjects and troubleshoot study-related questions or issues.
• Assist with study data quality checking and query resolution.
• Perform complex clinical research procedures including ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring.
• Record, report and interpret study findings to develop a study-specific database.
• Assist the investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements and quality standards.
• Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.
• Prepare for and attend study monitoring visits, audits, and regulatory inspections.
• Assist with coverage planning related to staffing and scheduling for research projects.

Skills & Qualifications

• BS/BA in life sciences or educational equivalent and/or relevant work experience in a clinical or medical setting.
• Knowledge of medical terminology and clinical trials, including departmental, protocol and study-specific operating procedures, consent forms, and study schedules.
• Strong IT competence, skilled in MS Windows and Office applications including Access, Outlook, Excel, and Word.
• Previous experience with EDC entry and query resolution.
• Excellent interpersonal and organizational skills with the ability to maintain close attention to detail and effective working relationships with co-workers, managers and clients.

A key member of the clinical research operations team, the Clinical Research Coordinator 2 leads database development for investigator-initiated projects, advises on protocol design and logistics, and coordinates internal and external audits from institutional, federal, and sponsoring entities. Collaborating across investigators, statisticians, and quality assurance reviewers, this coordinator advances study integrity by analyzing documentation such as adverse event reports and IRB materials and facilitating all daily trial activities from specimen collection through case report contribution.

Functions

• Plan and conduct clinical and non-clinical research and facilitate and monitor daily activities of clinical trials or research projects.
• Advise investigators on study protocol design and logistics of running research projects while aligning with budgeting, personnel and statistician analysis consultations.
• Lead development of databases when necessary for investigator-initiated research projects.
• Design data collection instruments.
• Coordinate and facilitate internal and external audits from institutional, federal, or sponsoring entities.
• Perform various aspects of clinical research, such as collecting and processing specimens, interviewing subjects, taking vital signs, and contributing to case reports.
• Coordinate and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
• Analyze study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

Professional Experience

• College or university degree in a related field.
• Less than 2 years of work experience in a related job discipline, with relevant research and clinical trials coordination experience.
• Previous experience with clinical research, consenting patients, and regulatory issues highly desirable.
• Knowledge of medical terminology, research techniques or methods, and regulatory policies and procedures.
• Knowledge of relevant scientific field.
• Proficiency in Microsoft Office, REDCap or compatible databases.
• Excellent written and oral communication skills.
• Analytical, problem-solving, and organizational skills with strong attention to detail.
• Ability to work independently and as part of a team with a large and diverse group of researchers and patients.

Regulatory compliance and participant safety in medical device and ocular imaging trials depend on the Clinical Research Coordinator, who manages GCP-certified study execution, adverse event reporting, and investigator file maintenance under the direction of the Principal Investigator. Based within a hospital network requiring off-site deployment across multiple locations, this coordinator serves as the primary liaison among investigators, ancillary departments, sponsoring organizations, and regulatory bodies to ensure protocol adherence and logistical continuity.

Accountabilities

• Manage clinical trials and assess medical device benefits and risks under the direction of the Principal Investigator.
• Attend clinics to recruit subjects for clinical studies.
• Assist investigators to recruit, screen, and follow up on participants in strict adherence to the study protocol, GCP Guidelines, and applicable regulatory and ethical requirements.
• Perform study procedures on participants, including consent taking, paperwork, and ocular imaging-related tests.
• Handle entry and validation of study data, extraction of relevant information from medical records, reporting of adverse events, maintenance of investigator files, and other essential documentation.
• Coordinate scheduling and conduct of clinical trials with hospital procedures for study participants as well as related finances and logistics.
• Ensure certification for GCP, local regulatory, and protocol compliance.
• Serve as primary liaison and coordination point between investigators, ancillary departments, research subjects, sponsoring organizations, and regulating bodies.
• Support general administration or coordination as required by the trials.

Requirements

• Degree or Diploma in Optometry, Nursing, or Sciences-related studies.
• 1 year of relevant experience in clinical trials, with GCP training an advantage.
• Excellent interpersonal and communication skills.
• Meticulous, diligent, and comfortable working in a multi-team setting.
• Comfortable handling medical devices with appropriate training.
• Willingness to be based off-site at different hospitals as applicable.

Clinical Research Coordinators in this network deliver efficient, high-quality trial operations across multiple sites in the broader metropolitan area, working closely with Principal Investigators, Trial Operations colleagues, and cross-functional teams to conduct studies and identify process improvement opportunities. The Trial Operations team relies on this work to maintain regulatory binder integrity, resolve EDC data queries, oversee Investigational Product accountability, and ensure sponsor, IRB, and auditor requests are addressed throughout each study's lifecycle.

Day-to-Day Responsibilities

• Review and attain fluency in study protocols.
• Contribute to the development of and execute on strategies to identify and reach patients potentially eligible for relevant studies across trial sites.
• Facilitate the patient informed consent process.
• Conduct patient screening, baseline, treatment, follow-up and other necessary study-related visits.
• Receive, store, account for and monitor Investigational Product.
• Maintain thorough understanding of safety reporting guidelines and monitor for and report Adverse Events and Serious Adverse Events.
• Collect, transport, process and ship biological samples, ensuring all appropriate tests, procedures and laboratory tests are completed.
• Collect, handle and store study data, including source documents, Case Report Forms and Electronic Data Capture systems.
• Ensure trial site regulatory binders are maintained throughout the lifecycle of studies.
• Clarify and resolve data queries in source documents and Case Report Forms.
• Proactively communicate with and facilitate collaboration among sponsors, investigators, patients, monitors, IRBs, vendors and other key stakeholders throughout studies.
• Assist with setting up, maintaining, and closing out trial sites throughout the study lifecycle.
• Respond to requests for information and access from inspectors and auditors.
• Contribute to the mapping and building of study-specific eSource.
• Support other coordinators, including conducting quality control checks and providing coaching and feedback to enable professional development.
• Contribute to the development of new processes, procedures, tools and training to enhance clinical research activities.
• Serve in an advisory capacity for cross-functional teams working on initiatives to improve the broader organization.

Background & Experience

• ACRP or SoCRA CRC Certification.
• Advanced Cardiac Life Support or Basic Life Support certification.
• Experience performing phlebotomy, collecting vital signs and performing ECGs.
• Certified rater status and fluency in EDC systems.
• Deep understanding of site-level quality and Good Clinical Practice Guidelines.
• Highly process-oriented and detail-focused with the ability to operate in a fast-paced environment with a high degree of ambiguity.
• Proactive, strategic, and implementation-focused with strong cross-functional collaboration skills.
• Collaborative, low-ego, and fast-learning approach to work.