CLINICAL RESEARCH ASSISTANT JOB DESCRIPTION

A Clinical Research Assistant handles the daily operational work that keeps IRB-approved protocols running cleanly. Without this role, participant consent lapses go undetected, case report forms accumulate errors, and data submitted to sponsors or federal agencies fails audit. The role sits within a study team reporting to a Principal Investigator or Study Coordinator, owning participant-facing procedures, regulatory documentation, and source-data integrity across one or more concurrent trials. GCP compliance and HIPAA-governed records management define the performance baseline here, not background expectations.

As the Clinical Research Assistant, you execute participant recruitment, consent, data collection, and regulatory documentation to keep clinical trials on protocol and on schedule. The position operates across active study sites, supporting investigators, project managers, and coordinating centers while maintaining the data quality standards required for federal or sponsor reporting.

Career Impact: Hands-on experience managing IRB submissions, informed consent procedures, and GCP-compliant documentation builds a credentialing foundation that opens pathways to Clinical Research Coordinator and Research Associate roles within two to three years.

Business Impact: Accurate source documentation and on-time data entry directly determine whether a trial's dataset is accepted by the FDA or sponsor - errors at this level can delay regulatory submissions or invalidate study arms.

Growth Opportunity: Exposure to federally funded studies, industry-sponsored drug and device trials, and multi-site data coordination expands your scope toward statistical reporting and protocol development responsibilities.

• Recruit, screen, and enroll study participants in accordance with IRB-approved eligibility criteria.
• Obtain informed consent and HIPAA Authorization forms from participants, ensuring documentation is complete and properly filed.
• Administer structured assessments, surveys, and questionnaires to enrolled participants by telephone and in person.
• Collect and record study data including anthropometric measurements, blood pressure readings, and biospecimen samples following protocol specifications.
• Enter data into case report forms and electronic data capture systems and resolve queries in a timely manner.
• Maintain source documentation, regulatory binders, and protocol files in compliance with GCP and federal requirements.
• Coordinate study visit scheduling, follow-up reminders, and supply inventory to sustain day-to-day trial operations.
• Support preparation of reports, data summaries, and presentation materials for the study team and external stakeholders.

• Bachelor's degree in a health science, biological science, social science, or related field, or equivalent work experience.
• 1 or more years of clinical research experience, including participant recruitment, data collection, informed consent, and regulatory documentation.
• Working knowledge of Good Clinical Practice standards and HIPAA-governed data handling requirements.
• Understanding of medical terminology sufficient to abstract and interpret data from patient medical records.
• Demonstrated ability to manage multiple concurrent study tasks accurately and meet protocol-driven deadlines.
• Strong written and verbal communication skills for interaction with participants, investigators, and coordinating center staff.
• Meticulous attention to detail in data entry, source document maintenance, and case report form completion.
• Ability to work independently with minimal supervision and within multidisciplinary team settings.

• Bachelor's degree in Biology, Chemistry, Biochemistry, Nursing, Epidemiology, or a directly clinical field.
• Prior experience with phlebotomy, specimen processing, or operating room sample collection procedures.
• Familiarity with electronic data capture platforms, electronic medical record systems, or statistical computing environments.
• Experience supporting federally funded studies or industry-sponsored drug and device trials, including IRB submission processes.

• Consent rate, measuring the proportion of screened participants who complete and sign valid informed consent.
• Data query resolution time, tracking how quickly discrepancies in case report forms are identified and corrected.
• Protocol deviation count per study period, reflecting adherence to IRB-approved procedures across active visits.
• Source document audit pass rate, measuring completeness and accuracy of regulatory binders during sponsor or internal review.
• Enrollment milestone attainment, comparing actual participant enrollment against protocol-defined timeline targets.
• Typical tools: Electronic data capture systems (commonly REDCap or similar); office productivity suites (commonly Microsoft Excel and Word).

• Base Salary Range: $38,000 to $52,000 per year, depending on experience and institution size.
• Bonus: Uncommon at this level; merit increases or step raises more typical.
• Equity: Not applicable for this role and seniority level.
• Health Benefits: Medical, dental, and vision coverage standard; employer contribution varies by institution.
• PTO: 10 to 15 days annually, plus federal or institutional holidays.
• Common Perks: Tuition assistance, professional development funding, and access to academic institution resources.

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

Background check completion, including criminal history review and, where applicable, drug screening, is a condition of employment for all positions. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, disability, veteran status, genetic information, or any other characteristic protected under applicable federal, state, or local law. Reasonable accommodations for individuals with disabilities are available upon request throughout the hiring process. Candidates must be legally authorized to work in the United States.

The Clinical Research Assistant owns coordination of multiple clinical trials in patients with dementia, managing research visits, regulatory procedures, and team operations under the direction of the principal investigator. Reporting to the PI and working closely with IRBs and study participants across multiple study sites, this role enables compliant, high-quality data collection in support of neuroscience and clinical research goals.

Key Responsibilities

• Oversee recruitment, enrollment, and study visits of research participants.
• Coordinate operations of clinical research activities such as study documentation, reporting, and logistics.
• Fulfill tasks related to starting a new program within the hospital including maintaining mailing lists, scheduling bi-weekly lab meetings, and purchasing supplies.
• Carry out study visits involving noninvasive brain stimulation, neuropsychological testing, and questionnaires.
• Lead weekly team meetings.
• Act as a point of contact for staff in multiple study sites.
• Train new employees and graduate students.

Required Qualifications

• High school diploma required; bachelor's degree preferred.
• Proficiency with basic computing packages such as MS Word and Excel.
• Strong interpersonal skills and comfort working with people.
• Sensitivity towards an older adult population required.
• High level of organization with careful attention to detail required.
• Comfort with technical skills required.
• High degree of motivation and self-sufficiency required.
• Ability to problem solve effectively and independently.

Embedded within a clinical research setting, the Clinical Research Assistant assists with the performance of clinical investigation projects including recruitment of study subjects, data collection and organization, and patient scheduling. Working closely with project leaders and the study team, this role delivers compliant documentation and accurate statistical reporting that supports the integrity of clinical investigations.

Core Functions

• Perform data entry for clinical investigation projects and maintain databases.
• Assist in the preparation of technical reports, summaries, and protocols.
• Maintain study-related documents and supplies in the investigator's office, organized and documented in accordance with all federal and state regulations.
• Create, collect, disseminate, and maintain appropriate files of study data.
• Assist with review and completion of study manuals and SOPs.
• Screen consents and/or schedule potential research participants for testing or evaluation.
• Facilitate follow-up assessment reminders and scheduling.
• Extract data from patient medical records and transcribe and resolve data queries in case report forms.
• Prepare documents under direction of project leaders.
• Report statistical analyses and descriptive data from patient study books for use in research and clinical investigation reports.
• Maintain awareness and compliance with research regulatory issues.
• Communicate regularly with study team via email and conference calls as needed.

Qualifications & Experience

• Bachelor's degree required.
• 1+ year of experience in research or clinical investigations required, including participant recruitment, data collection, data entry, informed consent, and scheduling.
• Prior experience within DoD or VA systems of care strongly preferred.
• Ability to follow detailed instructions required.
• Excellent communication and analytical skills required.
• Must adhere to legal, professional, and ethical codes with respect to confidentiality and privacy.

Reporting to study investigators and project managers, the Clinical Research Assistant ensures subject safety and data integrity by communicating trial procedure information and maintaining compliance with Good Clinical Practice, regulatory, and protocol requirements. Partnering with the Operations Supervisor, Charge Nurse, and coordinating staff across study teams, this role enables consistently reliable trial operations and source documentation quality.

Primary Duties

• Communicate subject or trial procedure information to the Operations Supervisor, Charge Nurse, Investigators, Project Managers, and Project Coordinators on an ongoing basis to ensure subject safety and data integrity.
• Ensure compliance with Good Clinical Practice, regulatory, and protocol requirements.
• Record study data and maintain source documentation according to Good Documentation Practices.
• Maintain knowledge of research protocols and attend education sessions provided to research staff involved in conducting trial procedures.
• Support members of study and project teams by reviewing source documents, reviewing clinical procedures, and drafting new or revised procedures.
• Follow teammate guidelines, employment policies, and department procedures.
• Provide consistent, regular, punctual attendance as scheduled.
• Assist with inventory, ordering, and stocking of food, linens, and supplies.
• Assist with the equipment maintenance and calibration program as needed.
• Provide input for performance evaluations and assist with orientation and training of new team members.

Skills & Qualifications

• Minimum high school diploma or equivalent required; minimum two-year technical degree or higher strongly preferred.
• 1 or more years of clinical research experience strongly preferred, or 2 or more years required for a senior-level position.
• Phlebotomy skills, Medical Assistant credential, or medical background strongly preferred.
• Able to work early morning, evening, night, or weekend shifts as necessary to support study schedules.
• Attention to detail and organization skills required.
• Strong data entry skills required.
• Basic computer skills and proficiency in Microsoft Word and Outlook required.

Sitting at the intersection of participant engagement and regulatory compliance, the Clinical Research Assistant screens and recruits study participants, administers surveys, and maintains confidentiality across all research activities. Operating across clinical study operations, data management, and team-based problem resolution, this role shapes the participant experience and supports the procedural integrity of research programs.

Duties

• Screen and recruit study participants.
• Enroll and consent study participants.
• Administer study surveys.
• Conduct study observations in a clinical setting.
• Enter data into secure databases.
• Support the research project and related program operations as needed.
• Work well in a group setting and participate in the resolution of operational problems.
• Apply policies, procedures, and methods while maintaining confidentiality.

Requirements

• High school diploma or Associate degree required; Bachelor's degree in a health-related field preferred.
• 0–1 years of experience required.
• Research experience desirable.
• Experience working and interacting with research participants.
• Demonstrated understanding of Good Clinical Practice and HIPAA.
• Knowledge of scientific concepts and research design.
• Understanding of ethical participant safety considerations.
• Familiarity with investigational products development and regulation.
• Knowledge of clinical study operations including GCPs, study and site management, and data management and informatics.
• Understanding of medical terminology and the research process.
• Experience in a healthcare setting desirable.
• Knowledge of university policies and procedures desirable.
• Strong interpersonal, oral, and written communication skills.
• Ability to multitask and work under time constraints and deadlines.
• Ability to work in a semi-independent manner with minimal supervision.
• Ability to work with diverse teams in a diplomatic, collaborative, and effective manner.
• Outstanding organizational and record-keeping skills with meticulous attention to detail.
• Strong computer skills.
• Ability to problem-solve and establish timelines and priorities.

A key member of the clinical research team, the Clinical Research Assistant leads protocol documentation support, subject eligibility assessment, and study enrollment tracking in accordance with HIPAA and approved protocols. Collaborating across investigators, Human Subject Committees, and clinical staff, this role delivers accurate data and sample management that keeps multi-project research operations on schedule.

Functions

• Assist PI in development of protocol-specific tools to aid in study documentation.
• Assess eligibility of research subjects in accordance with the approved protocol and all applicable regulations including HIPAA.
• Obtain patient consent and Human Subject Committee approvals for minimal-risk studies as delegated by approved protocol.
• Collect, record, evaluate, update, and store or transport pertinent data and samples in relation to protocol.
• Track study enrollment and completion of milestones.
• Summarize research findings and prepare presentations.
• Perform literature searches.
• Schedule patient tests and interviews.
• Conduct patient telephone follow-up.
• Stock, inventory, store, and order samples and supplies as needed to maintain appropriate operations.
• Review medical records and abstractions for consistency and completeness.
• Comply with established policies, health and safety regulations, procedures, and department objectives.
• Maintain patient and study subject confidentiality.

Experience & Qualifications

• Bachelor's degree in a scientific or healthcare field, or related experience.
• Experience in a healthcare setting, either clinical or research.
• Experience using computer-based tools including Word, Excel, Access, Outlook, and PowerPoint.
• Oral and written communication skills required.
• Excellent organizational and interpersonal skills required.
• Flexibility required, as work involves multiple concurrent projects.
• Off-site travel within the local area may be required.

Accurate participant data collection and compliant documentation of informed consent and HIPAA Authorization forms depends on the Clinical Research Assistant, who supports the implementation of a longitudinal trial examining the impact of dietary intervention on cognitive decline in post-stroke patients. Based within a multi-disciplinary study team and reporting to the Principal Investigator and Co-Principal Investigator, this role builds the data foundation required for valid outcomes across 500 randomized participants.

Accountabilities

• Assist with recruitment efforts, screen potential study participants, and schedule study visits as needed.
• Gather and prepare study-related materials for participant visits.
• Administer structured tests and questionnaires on cognitive function, depression symptoms, cardiovascular disease, stress, and physical activity by telephone and at in-person visits for 500 randomized participants.
• Enter data into study case report forms and electronic data capture systems and respond to queries in a timely manner.
• Collect and record anthropometric measurements of height and weight on post-stroke patients, as well as blood pressure readings.
• Demonstrate measurement reliability with structured tests, anthropometrics, and blood pressure readings.
• Utilize study-related technology and equipment as part of data collection procedures.
• Maintain accurate and complete documentation of signed informed consent and HIPAA Authorization forms, relevant approvals, source documentation, and study-related communication as assigned.
• Attend regular team meetings to discuss matters concerning participants, data collection, and problem solving.
• Interact effectively with the Principal Investigator, Co-Principal Investigator, Program Manager, and all trial staff.

Technical Qualifications

• High school diploma required; Bachelor's degree or higher in a health science-related field preferred.
• Experience conducting structured interviews or other forms of data collection preferred.
• Basic knowledge of email, Excel, Microsoft Office, and Adobe Acrobat required.
• Skilled in operating iPads and laptops.
• Ability to meet deadlines required.
• Detail-oriented with a high attention to accuracy required.
• Ability to build rapport, navigate sensitive topics, and maintain confidentiality with a diverse pool of research participants.
• Effective verbal and written communication skills required.
• Outstanding communication skills and ability to work with a diverse group of individuals in a professional manner.
• Excellent organizational, interpersonal, problem-solving, and analytical skills required.
• Ability to focus on tedious mental tasks with great accuracy, including high-volume clerical and data entry work with strict deadlines.
• Ability to collaborate within multi-disciplinary team settings.
• Availability to work evenings, overnight, and weekends if required under study protocols.

As the Clinical Research Assistant, this role owns patient registration, protocol compliance monitoring, and data flow management for applicable research studies. The clinical research program relies on this work to ensure that study requirements are met, documentation is complete, and data submitted through research protocols reflects accurate and timely patient information.

Activities

• Maintain current and accurate protocol documentation and notify appropriate individuals of pertinent protocol changes.
• Identify and communicate important protocol and data management issues to appropriate individuals.
• Verify that patients have completed appropriate registration materials and maintain related records and information.
• Instruct volunteers on protocol requirements and explain procedures and consent forms.
• Ensure related documentation is properly completed.
• Ensure protocol compliance through intense monitoring of specific study requirements and schedule protocol-related treatment and tests.
• Perform specific clinical duties as required per the research study.
• Assist in ordering and maintaining research supplies as directed.
• Prepare and maintain a variety of documentation in the assigned area of responsibility.
• Serve as a backup for collecting and delivering specimens for analysis using appropriate equipment, ensuring proper labeling and obtaining pertinent clinical and protocol information on request forms.
• Interact with patients, families, visitors, physicians, and related clinical departments as required by the position.

Position Requirements

• High school diploma, GED, or equivalent working knowledge required; Associate's degree or Certified Research Assistant certification preferred.
• 1–2 years of clinical research experience required.
• Knowledge of basic laboratory procedures, preferably obtained through experience in a health care or research setting.
• Knowledge and understanding of medical terminology required to read, identify, and extract pertinent data from medical records.
• Knowledge of data entry and computer programs associated with maintaining databases and spreadsheets required.
• Ability to multi-task and re-prioritize duties as needed.
• Ability to maintain confidentiality required.
• Excellent human relations, organizational, and communication skills required.

Clinical Research Assistant I coordinates study database accuracy and completeness, preparing weekly and monthly data summaries, descriptive statistics, and graphics while querying study sites on data entry certification and reliability monitoring. The work directly supports a Data Coordinating Center team including study biostatisticians, applications developers, and clinical and administrative personnel at partner institutions.

Operational Focus

• Work on general coordination for the study including monitoring and maintenance of accuracy, completeness, and consistency of the study database.
• Query study sites regarding data entry certification, possible data errors, and reliability monitoring.
• Prepare weekly and monthly data summaries, descriptive statistics, and graphics.
• Assist in the preparation of documents and reports.
• Work closely with other members of the coordinating center, including study biostatisticians, applications developers, and clinical and administrative personnel at partner institutions, as well as with physicians, nurses, and research coordinators at study sites.

Knowledge Skills & Abilities

• Bachelor's degree required, preferably in a health science, quantitative, or related field.
• Strong computer skills including Excel, Word, and PowerPoint, and ability to learn new database and statistical computing skills including REDCap, InForm, SAS, or other statistical programs.
• Attention to detail essential.
• Flexibility in day-to-day activities required.
• Strong communication skills required, as the position involves considerable interaction with study personnel by phone, videoconference, and email.

The Clinical Research Assistant 2 oversees specimen collection and medical records management across outpatient and operating room settings, supporting research consent procedures and regulatory document maintenance. Working with associates across departments, this role advances research data integrity by abstracting and entering patient data from electronic medical records in support of clinical study objectives.

Key Deliverables

• Obtain medical records.
• Screen subjects using electronic medical records systems.
• Obtain research consent from human subjects.
• Facilitate the collection of human samples in the outpatient setting and operating room.
• Perform basic sample processing.
• Contact patients for research data collection.
• Perform patient data entry and abstract patient data from medical records.
• Assist in the maintenance of regulatory documents.
• Communicate with associates in other departments.

Professional Experience

• Bachelor's degree required; OR Associate's degree and 2 years of relevant experience; or 3 years of related experience; or an equivalent combination of education and experience.
• Bachelor's degree in Biology, Chemistry, Biochemistry, or other science preferred.
• 1 or more years of research experience preferred.
• Previous experience working in a clinical environment preferred.
• Basic clinical research knowledge required.
• Medical terminology knowledge required.
• Working knowledge of clinical research data management activities required.
• Database maintenance experience and fluency with electronic medical record programs preferred.
• Proficient with MS Office Suite.
• Ability to become phlebotomy certified within the first 6 months required.
• Excellent communication skills required.
• Ability to work independently as well as in a team environment required.
• Excellent attention to detail, organization, and time management skills required.

Embedded within federally funded and industry-sponsored trauma and critical care research programs, the Clinical Research Assistant develops data collection instruments, conducts participant interviews, and produces statistical reports in support of studies spanning traumatic brain injury, sepsis, and acute lung injury. Reporting to research personnel and collaborating with institutions, government agencies, and funding bodies, this role refines the quality and compliance of data used in grants, manuscripts, and regulatory submissions.

Areas of Ownership

• Communicate directly with participants regarding the research study.
• Perform data collection by conducting research interviews, reviewing medical charts, and accessing computerized medical information systems.
• Recruit and screen subjects for research studies according to approved protocols.
• Verify participant eligibility, obtain consent and enrollment, and assure accurate demographic information for follow-up.
• Establish and maintain database files and reports using computer applications.
• Perform data checks, audits, and data cleaning.
• Check validity and accuracy of data to ensure compliance with quality control requirements and study relevance.
• Develop data collection instruments such as survey questionnaires.
• Perform data analysis and interpretation and develop statistical reports using descriptive statistics and statistical software.
• Assist in developing, submitting, and providing content for grants, papers, abstracts, manuscripts, and presentations.
• Conduct and analyze literature searches.
• Assist research personnel in the development of research protocols and materials by providing study analysis and forming conclusions and recommendations.
• Assist in developing and recommending policies, procedures, and design methods for clinical research activities.
• Provide training and guidance to interviewers and participate in field visits.
• Respond to requests and questions from individuals, institutions, government agencies, and funding agencies.
• Participate in the design of research studies.
• Maintain inventory of biospecimens and perform specimen collection and processing.

Education & Experience

• Bachelor's degree in epidemiology, sociology, psychology, biology, emergency health services, nursing, or a science field related to clinical research required.
• Ability to understand and utilize scientific and medical terminology in oral and written communications.
• Ability to understand and apply approved guidelines of varying research protocols.
• Knowledge of best practices in research protocols and procedures.
• Knowledge of reporting requirements for Institutional Review, Human Protections, Animal Protections, and related policies.
• Skill in various interviewing techniques.
• Skill in data abstraction and entry into study-specific database software applications.
• Skill in statistical interpretation and data analysis using statistical software, spreadsheet, and database applications.
• Ability to maintain high standards, stay current with trends, and take personal responsibility for all outcomes.
• Ability to make effective and timely decisions and use technology effectively.
• Ability to effectively communicate both verbal and written thoughts, ideas, and facts.
• Ability to write and present information in a clear and concise way.
• Ability to maintain confidentiality of subjects and information obtained.
• Excellent organizational and project management skills.
• Ability to work cooperatively with others and demonstrate professional, ethical, respectful, and courteous behavior.
• Ability to use measurable and verifiable information for making decisions or judgments.
• Ability to use a consultative approach to resolve issues in area of responsibility.