Clinical Research Specialist Job Description

A Clinical Research Specialist is the named sponsor contact between medical device manufacturers and the investigator sites that keep their study agreements, site budgets, and essential documents running accurately. Device manufacturers, CROs, and developers of software as a medical device each need someone who understands both the site relationship and the regulatory mechanics beneath it, a distinction that separates this role from site-based study coordination. Within the organization, the specialist sits inside a clinical operations or clinical affairs team and is held accountable for the timeliness and accuracy of study start-up and documentation that directly affect pre-market submission timelines. Regulatory obligations such as Investigational Device Exemption rules, ISO 14155, and 21 CFR requirements set the professional baseline for this work.

As the Clinical Research Specialist, you keep sponsored device studies contract-ready and audit-ready so pre-market evidence reaches regulators on the timeline the product plan depends on. You sit within the clinical operations group, answering to clinical management while serving as the sponsor's main point of contact for investigators and site staff on each study.

Career Impact: Running pre-market IDE studies and supporting competent authority audits by agencies such as PMDA gives you the sponsor-side record hiring managers look for in Senior Clinical Research Specialist candidates.

Business Impact: Accurate site payments and on-time clinical evaluation reports keep investigators engaged and let regulatory teams file device submissions without costly data gaps.

Growth Opportunity: Preparing Steering Committee materials and protocols for software as a medical device studies builds skills that grow in value as AI-based imaging products enter regulated clinical research.

• Lead clinical trial agreement and budget negotiations with investigator sites to ensure timely execution of sponsored device studies.
• Drive study start-up activities, including site qualification, investigator recruitment and IRB approval, for sponsor-initiated device trials.
• Maintain essential documents and trial master files within compliance guidelines, quality checking them for accuracy and completeness.
• Monitor data collection compliance across study sites, tracking enrollment, milestones and timelines against the study plan.
• Coordinate site training and investigator meetings to support consistent protocol execution and data collection.
• Develop protocols, case report forms and study-specific templates in collaboration with data management and clinical teams.
• Audit study documentation and support competent authority inspections to ensure compliance with GCP and FDA regulations.
• Track investigator payments against executed agreements and report study budget, timeline and risk status to management.

• Bachelor's degree in life sciences, nursing, medical science or a related field or equivalent work experience.
• Four or more years of clinical research experience, with at least one year at an industry sponsor or CRO.
• Working knowledge of ICH GCP guidelines and FDA regulations governing investigational device studies.
• Experience with pre-market IDE or comparable regulated study start-up, including site qualification and training.
• Understanding of medical terminology and medical device procedures sufficient to review protocols and site questions.
• Ability to manage regulatory documentation, essential documents and study records accurately against Good Documentation Practices.
• Clear written and verbal communication for working with investigators, site staff and internal stakeholders.
• Ability to organize large data sets and manage competing study priorities with strict attention to detail.

• Clinical research certification such as CCRC or CCRA, or willingness to obtain one within the first year.
• Experience negotiating research contracts and developing study protocols for sponsor-initiated device trials.
• Experience preparing medical device regulatory submissions, safety reporting and responses to competent authority requests.
• Background in cardiac, surgical or software as a medical device research, including artificial intelligence or medical imaging studies.

• Contract cycle time in days, reflecting how quickly site agreements and budgets are executed.
• Site activation rate against plan, measuring start-up speed from qualification to first enrollment.
• Essential document completeness percentage, showing trial master file readiness for audits.
• Data collection compliance rate by site, tracking protocol-required entries completed on time.
• Investigator payment accuracy percentage, reflecting correct payments against executed agreements.
• Audit findings count per study, measuring documentation compliance under inspection.
• Typical tools: Trial document management (commonly eTMF systems).

• Base Salary Range: $85,000 to $120,000 per year, higher for senior-level specialists
• Bonus: Annual performance bonus, typically 5% to 10% of base salary
• Equity: RSUs or employee stock purchase plans at larger device manufacturers
• Health Benefits: Medical, dental and vision coverage with employer-paid premiums for employees
• PTO: 15 to 20 days annually plus paid company holidays
• Common Perks: 401(k) match, certification reimbursement, conference travel and hybrid scheduling

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

Offers are contingent on a successful background check, which for clinical research positions may include screening against FDA debarment lists. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status or any other characteristic protected by federal, state or local law. Reasonable accommodations are available on request throughout the hiring process. Candidates must be authorized to work in the United States.

The Clinical Research Specialist I delivers accurate participant and study records across clinical research studies, from eligibility screening and informed consent through completed case report forms. Reporting into the clinical research team and communicating with the Investigator, Sponsor and internal constituents, the specialist keeps documentation compliant with GCP guidelines and regulatory requirements so studies stay inspection-ready.

Key Responsibilities

• Assist with submitting related documents to the appropriate regulatory review committees and maintaining regulatory files.
• Perform assigned clinical research activities including screening participants for eligibility and recruitment, obtaining informed consent, educating participants on study requirements and completing source documents and case report forms.
• Maintain in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines.
• Document, record and assimilate accurate participant and study records to ensure compliance with sponsor guidelines, standard operating procedures (SOP) and internal and external regulatory agencies.
• Establish and maintain communications with the Investigator, Sponsor and internal constituents.

Required Qualifications

• Bachelor's degree, or Associate's degree with 4 years of healthcare or research-related experience.
• Certification in Human Subjects Protection (CITI Training) obtained within 1 month of hire, with DOT IATA Training preferred.
• Experience in a team setting is desirable.
• Medical terminology or basic research terminology preferred.
• Detail-oriented with the ability to collect, compile and analyze information.
• Computer skills in Excel, PowerPoint and Word.
• Ability to assist with multiple projects, work independently on multiple tasks and manage time effectively.
• Excellent verbal, written, interpersonal and communication skills.

Embedded within the sponsor's clinical research team, the Clinical Research Specialist owns Investigational Device Exemption (IDE) studies end to end, from clinical trial agreement and budget negotiations to eTMF and EDC oversight. Working closely with study sites, vendors, investigators and management, the specialist keeps enrollment, costs and milestones visible so device trials run on schedule, within budget and in line with GCP standards.

Core Functions

• Manage Investigational Device Exemption (IDE) clinical research studies and evaluate and analyze clinical data.
• Maintain Electronic Trial Master File (eTMF) and Electronic Data Capture (EDC) systems, securing essential documents and quality-checking files and the EDC for accuracy and completeness.
• Secure essential vendor documents to establish accounts in the A/P system, establish billing system accounts and issue payments to vendors and investigators according to executed agreements within compliance guidelines.
• Lead clinical trial agreement and budget negotiations to ensure efficient, timely processing of agreements and execution of clinical studies.
• Track and report study status, enrollment, regulatory documentation, site start-up status, budget and timelines, and communicate status with study sites.
• Order, distribute, receive and track investigational product and study supplies.
• Assist in user acceptance testing in the EDC and eTMF, evaluate new database updates and help prepare technical reports, summaries, templates, protocols and other study related documents.
• Oversee data collection compliance via tracked milestones and maintain all pertinent study correspondence between the sponsor, study sites and third parties.
• Lead investigational site training and meetings, and assist site coordinators with IRB submissions as necessary.
• Develop clinical research standard operating procedures and work instructions, identify and mitigate quality risks or issues, and ensure studies are conducted in accordance with all relevant ethical and government standards, GCPs and Standard Operating Procedures.
• Keep management and stakeholders informed on assigned clinical study metrics and project information, including costs, timelines and milestones.

Qualifications & Experience

• Bachelor's degree.
• Clinical Research Certification, or obtained within one year.
• Four years of clinical research experience, including pre-market IDE or IND study experience.
• One year of industry-sponsored or CRO employment.
• Knowledge of ICH guidelines and FDA regulations relevant to clinical studies.
• Comprehension of medical terminology or ability to reference literature for understanding.
• Proficient software skills in Word, Excel, PowerPoint and databases.
• A combination of education, experience and RA influence may be considered.

Reporting to multidisciplinary project teams, the Clinical Research Specialist I builds research protocols, data collection tools and qualitative and quantitative data sets for applied research and evaluation projects serving families and children. Partnering with research partners and clients across social services, early education and pediatric healthcare, the specialist converts analyses and literature reviews into findings that inform policy and practice.

Primary Duties

• Support and coordinate research and evaluation activities with research partners.
• Coordinate, execute and support development of research protocols and data collection tools.
• Develop and synthesize data sets, collect and manage qualitative and quantitative data and conduct analyses.
• Contribute to interpretation, reporting and dissemination of research findings.
• Solve problems and communicate solutions to project stakeholders.
• Conduct literature reviews and keep abreast of trends and developments in the field.
• Provide administrative support to project teams.
• Coordinate, facilitate or participate in meetings with clients.
• Collaborate with team members to seek and prepare applications for research funding.

Skills & Qualifications

• Bachelor's degree with 3 years of experience or Master's degree with 1 year of experience, preferably in child development, psychology, public health, early childhood education or a related field.
• Experience with research or evaluation projects.
• Foundational coursework in research design and measurement.
• Statistical ability and beginning knowledge of statistical software.
• Strong leadership, interpersonal, collaboration, verbal and written communication skills.
• Solution-focused problem-solving and creative thinking skills.
• Commitment to understanding and working towards equity and inclusiveness and embracing principles of equity, diversity and inclusiveness in work.

Sitting at the intersection of sponsor operations and investigator sites, the Clinical Research Specialist shapes company-initiated device studies by creating protocols and study documentation, qualifying investigators and launching site start-up activities. Operating across data management, compliance and research site teams, the specialist serves as the main line of communication with sites, lifting data collection compliance and moving projects through IRB approval and global research review.

Duties

• Provide accurate status reports and updates on assigned clinical research projects.
• Facilitate data report creation to meet company and researcher goals and appropriate documentation to maintain compliance with the AP and Compliance department.
• Facilitate clinical contract agreements between the company and the Site for company-initiated studies.
• Assist the data management team with electronic data capture system CRF design, eTMF design, CTMS design and user testing for assigned studies.
• Audit, recruit and qualify potential research investigators to conduct clinical research and maximize clinical research efforts.
• Provide the main line of communication with research sites, respond to site inquiries and conduct site training for data collection initiatives.
• Monitor data collection compliance and communicate with sites to optimize it.
• Facilitate preparation of pending clinical research projects for global research review and IRB approval at the site level.
• Create protocols, case report forms and information packets for clinical studies.
• Initiate site start-up activities for company-sponsored studies.

Requirements

• Four years of relevant clinical research experience.
• One year of industry sponsor or CRO employment.
• Experience managing research contracts and protocol development preferred.
• Basic ability to identify a research hypothesis and proposed outcome measures to address the hypothesis.
• Ability to read surgical techniques and basic understanding of the medical devices necessary to perform the procedure preferred.
• Ability to organize and manipulate large data sets.
• Good communication, documentation and record-keeping skills.

A key member of the patient recruitment team, the Clinical Research Specialist builds a steady pipeline of study candidates by contacting referrals, screening patients with study-specific scripts and tracking each subject's progress in a computerized database. Collaborating across peers, management and study sites, the specialist improves referral retention and helps sites meet enrollment needs.

Functions

• Contact referrals through phone and email communication.
• Maintain a record of all communications within a computerized database.
• Update the status of all subjects in the database by following up with patients on their progress through the recruitment process.
• Develop and use study-specific scripts to screen patients.
• Assist management in implementing effective referral retention strategies.
• Attend all required team meetings within the company.
• Communicate regularly with peers to determine study sites' needs.
• Proactively identify challenges or potential efficiencies and raise them to the team.

Experience & Qualifications

• Customer service, patient service or patient call centre experience preferred.
• Experience working in a clinical research setting is an asset.
• Knowledge and application of ICH-GCP and FDA guidelines.
• Strong proficiency in Microsoft Office programs (Excel, Outlook, Word) and web applications.
• Excellent oral and written communication skills.
• Well-developed interpersonal skills and the ability to work well independently and with co-workers, peers and supervisors.
• Ability to handle multiple tasks and projects simultaneously, effectively and efficiently with precision and good attention to detail.
• Self-motivated and driven to reach goals and objectives with limited management oversight.
• High degree of integrity and ability to maintain confidentiality regarding patient matters and other sensitive information.

Timely, compliant evidence for AI-based medical imaging products depends on the Senior Clinical Research Specialist, who leads assigned clinical studies from planning and risk monitoring through ethics submissions and clinical evaluation reports. Serving as the liaison between lead clinicians and regulatory, quality, product and technical teams, the specialist moves study results into manuscripts and conference abstracts that support product development.

Accountabilities

• Manage the planning and execution of assigned clinical studies.
• Monitor risk management of assigned clinical studies.
• Manage timely completion of documentation and activities supporting the development of the company's products, such as clinical study plans, ethics submissions and clinical evaluation reports.
• Conduct or assist with manuscript submissions and conference abstracts as required.
• Manage liaisons between external and internal stakeholders such as lead clinicians, regulatory, quality, product, technical and systems.

Technical Qualifications

• Bachelor's degree in a relevant field such as nursing, life sciences or medical science.
• PhD or post-graduate qualification in a relevant area of medical science.
• Experience working in clinical research and the medical device industry.
• Experience working with regulatory bodies and with FDA submissions.
• Experience in research involving artificial intelligence, SAMD or medical imaging.
• Strong knowledge of 21 CFR, ICH/GCP and ISO 14155 2020 requirements.
• Experience performing statistical analysis or programming expertise.

As the Senior Clinical Research Specialist, this role owns research compliance across a health system's clinical trials, from investigational drug and device oversight to annual conflict of interest reviews. The research administration function relies on this work to turn CMS, FDA, HIPAA, and OHRP requirements into policies and training for researchers and clinical teams, reducing legal and financial risk.

Activities

• Provide research partners with guidance, information, and assistance in complying with system operations, policies, and processes related to research, and encourage diversity within research protocols to achieve academic goals.
• Provide research billing compliance guidance and oversight.
• Collaborate with research partners on protocol development, IRB applications, consent forms and HIPAA authorizations, and communicate with the IRB and sponsors.
• Conduct the annual research conflict of interest assessment with researchers, including tracking, review, and development of management plans.
• Ensure investigational drug and device regulations are implemented and followed, and track and help ensure compliance with federal, state, and local research regulations and requirements.
• Assist in developing and implementing training and education programs for internal and external researchers to disseminate system-wide research process knowledge.
• Use and manage databases, including clinical trial management and electronic medical record systems.
• Develop policies and company procedures for complying with new regulations or requirements, manage their implementation, and establish best practices for compliant research.
• Provide research support and act as liaison between researchers and clinical teams, including lab, imaging, and pharmacy.
• Provide care or service adjusted to the developmental level and cultural differences of the population served, partner with the patient caregiver in care and decision-making, individualize plans of care, modify clinical interventions, and provide patient education based on assessed learning needs.
• Communicate respectfully, ensure a safe and secure environment, foster a culture of improvement, efficiency and innovative thinking, complete all required learning, comply with and maintain knowledge of relevant laws, regulations, policies, procedures and standards, and perform other duties as assigned.

Position Requirements

• Bachelor's degree in a related or healthcare-related field, with additional training or education in healthcare administration or research.
• Nursing license (RN or LPN) and Research Certification such as CCRC or CCRA.
• Four years of clinical research experience with one year of regulatory experience.
• Five or more years of clinical research experience in an academic setting and two years of regulatory experience.
• Knowledge of Institutional Review Board regulations.
• Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Knowledge of Microsoft Applications.
• Experience with Epic preferred and with the OnCore clinical trial management system.

Senior Clinical Research Specialist delivers inspection-ready study documentation for cardiac and medical device trials, managing study start-up and conduct activities and leading internal and competent authority audits. The work directly supports cross-functional partners in clinical data management and field teams, cutting recurring issues through process improvements and keeping sponsor studies compliant with Good Documentation Practices and domestic and international regulations.

Operational Focus

• Manage study start-up and study conduct activities, including ICF review, developing study-specific templates and the TMF plan, and approving and managing study-specific essential documents.
• Manage and communicate the status of study progress and activities, and drive resolution of issues encountered with sites during all phases of the study.
• Partner with cross-functional teams such as clinical data management and field teams on query management, data reviews and resolution.
• Lead the investigation of all discrepancies identified in study documentation reconciliation.
• Develop and implement processes to mitigate recurrence of issues throughout the study.
• Lead assessment of current and new processes, identifying and implementing solutions to improve process efficiency within and across related functional areas.
• Conduct in-house and site reviews of associated documentation and lead internal and competent authority audits (e.g., FDA, DEKRA, PMDA) to ensure compliance with Good Documentation Practices, internal SOPs, and domestic and international regulations.
• Provide coaching and knowledge transfer to team members.
• Prepare materials for meetings such as Steering Committee and Investigator meetings.

Knowledge Skills & Abilities

• Bachelor's degree in a related field.
• 5 years of previous experience with regulatory documentation for clinical studies.
• Experience in site monitoring, site qualification, and site training.
• Experience in cardiac research, sponsor clinical trial operations, and medical device trials preferred.
• Full knowledge and understanding of company policies, procedures, and international and domestic medical device regulations and guidance relevant to clinical protocols.
• Full understanding of regulatory submissions, reporting, and audits.
• Proven expertise in MS Office Suite and clinical systems such as CTMS (Clinical Trial Management System) and eTMF (electronic Trial Master File) preferred.
• Excellent written and verbal communication, interpersonal relationship, problem-solving and critical thinking skills.
• Strict attention to detail and ability to manage confidential information with discretion.
• Ability to manage competing priorities in a fast-paced environment.
• Ability to work in team environments, including inter-departmental teams, interact professionally with all organizational levels and senior internal and external personnel on significant matters, and serve as key contact representing the organization on contracts or projects.
• Adhere to all company rules and requirements, such as pandemic protocols and Environmental Health and Safety rules, with adequate control measures to prevent injuries and protect the environment.