Job Overview
We are seeking a highly motivated, experienced, and exceptionally detail-oriented Clinical Research Associate (CRA)-– Regulatory & Site Operations to join our growing clinical research team. This is a hands-on, site-based position with significant responsibility for regulatory affairs, study start-up, clinical trial coordination, documentation quality, patient-facing research activities, and ongoing study compliance.
The ideal candidate will have strong clinical research experience and must be particularly skilled in regulatory affairs. This individual will play an important role in ensuring that clinical trials are initiated, conducted, maintained, and closed in accordance with study protocols, sponsor requirements, Institutional Review Board (IRB) requirements, FDA regulations, ICH Good Clinical Practice (GCP), HIPAA, applicable Standard Operating Procedures (SOPs), and federal research requirements.
The Clinical Research Associate will work closely with Principal Investigators, Sub-Investigators, clinical research staff, sponsors, Contract Research Organizations (CROs), monitors, laboratories, vendors, and administrative personnel. The successful candidate must be able to independently manage competing study priorities, recognize regulatory and documentation deficiencies, anticipate deadlines, and proactively resolve issues before they affect study timelines, compliance, or patient safety.
This position requires a professional who is equally comfortable working with regulatory documents and sponsor communications as with patients, study visits, clinical documentation, data entry, and research-site operations.
This is an in-person, multi-site position. Candidates must be able and willing to work at both of our locations based upon study schedules and operational needs:
Washington, DC 20037
Annapolis, MD 21401
Reliable transportation and the ability to travel between both locations are required.
Essential Duties and ResponsibilitiesRegulatory Affairs & Study Compliance
- Serve as a key resource for regulatory activities throughout the lifecycle of assigned clinical trials, from study start-up through closeout.
- Prepare, review, organize, submit, maintain, and track regulatory documentation required by sponsors, CROs, IRBs, and applicable regulatory authorities.
- Coordinate and support initial IRB submissions, amendments, continuing reviews, reportable events, protocol updates, informed consent form revisions, and study closure documentation.
- Maintain accurate, complete, organized, and inspection-ready regulatory binders and essential study documents.
- Maintain and monitor delegation of authority logs, financial disclosure forms, investigator documentation, CVs, licenses, training records, protocol signature pages, laboratory certifications, equipment documentation, and other essential regulatory records.
- Review study documentation for accuracy, completeness, consistency, timeliness, and compliance with protocol, sponsor, IRB, FDA, and GCP requirements.
- Track regulatory deadlines, outstanding documents, approvals, expirations, training requirements, and study-specific compliance obligations.
- Identify regulatory deficiencies or compliance concerns and proactively coordinate corrective action with research staff, investigators, sponsors, CROs, or other appropriate parties.
- Maintain study files in a state of continuous audit and inspection readiness.
- Assist with sponsor monitoring visits, quality reviews, audits, and FDA inspections, including document preparation, reconciliation, follow-up, and corrective-action activities.
- Respond to regulatory and sponsor requests in a timely and professional manner and maintain appropriate documentation of communications and resolutions.
Clinical Trial Operations
- Coordinate and manage assigned aspects of clinical trials from study start-up and activation through enrollment, maintenance, and closeout.
- Review protocols and study requirements and translate them into practical site workflows, visit schedules, documentation requirements, and operational responsibilities.
- Support site qualification, feasibility assessments, study initiation activities, investigator meetings, site activation requirements, and study closeout activities.
- Coordinate subject recruitment, prescreening, screening, enrollment, scheduling, study visits, follow-up, retention, and completion activities.
- Ensure study procedures are conducted within protocol-required visit windows and in accordance with approved study requirements.
- Maintain study calendars, visit schedules, recruitment/enrollment trackers, screening logs, subject identification logs, and other required study tracking tools.
- Coordinate monitor visits, sponsor communications, study meetings, and follow-up activities.
- Communicate professionally with sponsors, CROs, monitors, laboratories, vendors, investigators, and other research partners regarding study requirements, documentation, deadlines, and outstanding action items.
Patient Care & Clinical Research Procedures
- Assist with and coordinate study visits in accordance with protocol requirements and within the individual’s training and scope of responsibility.
- Obtain and document vital signs and other protocol-required clinical measurements as appropriate.
- Perform or assist with phlebotomy/blood collection, specimen processing, packaging, storage, and shipment when appropriately trained.
- Review relevant medical histories and research documentation to assist investigators and research staff with protocol-required study activities.
- Maintain accurate documentation of study procedures, patient communications, clinical findings, and research activities.
- Support the informed consent process in accordance with FDA, GCP, IRB, sponsor, and site requirements.
- Monitor and document adverse events, serious adverse events, protocol deviations, and other reportable events and promptly escalate matters requiring investigator or medical review.
- Protect the rights, safety, privacy, confidentiality, and welfare of research participants at all times.
Data Management & Documentation
- Complete and/or oversee timely and accurate source documentation and clinical research data entry.
- Enter and maintain study data in Electronic Data Capture (EDC) systems, electronic Case Report Forms (eCRFs), sponsor portals, and other clinical research systems.
- Review data for accuracy, consistency, completeness, and source-document support.
- Respond to sponsor and monitor data queries and assist with documentation reconciliation.
- Work with electronic medical record (EMR) systems while maintaining appropriate separation between research records and medical records where required.
- Maintain accurate tracking of study visits, laboratory results, investigational product information, adverse events, protocol deviations, subject status, and study-specific requirements.
- Support data-quality initiatives and maintain familiarity with applicable clinical research data standards, including CDISC principles where relevant to assigned studies.
Laboratory & Specimen Management
- Coordinate protocol-required laboratory activities and communicate effectively with internal and external laboratory personnel.
- Ensure specimens are collected, processed, labeled, stored, documented, and shipped according to protocol, laboratory manual, sponsor, and regulatory requirements.
- Maintain required laboratory documentation, temperature logs, shipment records, equipment logs, expiration records, and other study-specific documentation.
- Identify specimen or laboratory discrepancies and coordinate timely resolution.
Quality Assurance & Audit Readiness
- Routinely review study files and research documentation to identify missing, incomplete, inconsistent, or noncompliant records.
- Perform internal quality-control reviews before monitor visits, sponsor audits, or regulatory inspections.
- Assist with the development and implementation of corrective and preventive actions when deficiencies are identified.
- Ensure study documentation follows ALCOA+ principles and maintains appropriate standards for data integrity and traceability.
- Support continuous improvement of research workflows, regulatory processes, documentation practices, and study-management procedures.
Team & Operational Responsibilities
- Provide guidance and support to clinical research staff regarding protocol requirements, regulatory documentation, study procedures, and documentation standards.
- Assist with training and onboarding research staff on study-specific procedures, regulatory expectations, GCP principles, documentation practices, and site workflows.
- Help ensure assigned responsibilities are completed accurately and within required timelines.
- Escalate unresolved study, regulatory, staffing, patient-safety, or compliance concerns to research leadership and/or the Principal Investigator as appropriate.
- Participate in research team meetings, sponsor meetings, investigator meetings, training sessions, and other study-related activities.
- Maintain professional and collaborative relationships with investigators, patients, research staff, sponsors, CROs, monitors, laboratories, and external partners.
- Perform additional clinical research and administrative duties as necessary to support the needs of the research program.
Required Qualifications
- Prior professional experience in clinical research, clinical trial operations, regulatory affairs, or a closely related healthcare research environment.
- Strong working knowledge of clinical research regulatory requirements, with demonstrated experience maintaining regulatory documentation and study files.
- Knowledge of FDA regulations, ICH Good Clinical Practice (GCP), IRB requirements, HIPAA, informed consent requirements, and clinical trial documentation standards.
- Experience supporting study start-up, regulatory submissions, study maintenance, monitor visits, audits, and/or study closeout activities.
- Ability to review complex study documentation and identify missing information, inconsistencies, compliance concerns, and required corrective actions.
- Strong understanding of medical terminology and clinical research documentation.
- Experience working with EDC systems, electronic medical records, sponsor/CRO portals, and other clinical research technology.
- Strong written and verbal communication skills.
- Exceptional organizational skills and attention to detail.
- Ability to independently prioritize and manage multiple studies, deadlines, regulatory requirements, and competing responsibilities.
- Ability to work effectively with Principal Investigators, sponsors, CROs, monitors, patients, clinical personnel, and administrative staff.
- Ability to maintain confidentiality and exercise appropriate professional judgment when handling protected health information and sensitive research information.
- Must be able and willing to work at both the Washington, DC 20037 and Annapolis, MD 21401 locations.
- Reliable transportation between both clinical research locations is required.
Preferred Qualifications
- Significant experience in clinical research regulatory affairs strongly preferred.
- Previous experience in a Clinical Research Associate, Clinical Research Coordinator, Regulatory Coordinator, Senior Clinical Research Coordinator, or similar clinical research position.
- Experience independently preparing and maintaining regulatory binders and managing IRB submissions.
- Experience with sponsor and CRO communications, monitoring visits, audits, study start-up, and study closeout.
- Current ICH-GCP training/certification from a recognized training provider preferred.
- Phlebotomy experience or certification strongly preferred.
- Nursing, medical assisting, laboratory, or other relevant clinical background is desirable.
- Familiarity with clinical laboratory procedures, specimen handling, investigational products, and research-specific shipping requirements.
- Experience with multiple simultaneous clinical trials and the ability to transition efficiently between studies and competing priorities.
- Previous experience providing guidance, training, or supervision to clinical research staff is preferred.
- Familiarity with CDISC standards and clinical research data-quality principles is a plus.
Successful Candidate Profile
The successful candidate will be someone who does not wait until a monitor visit or audit to identify a problem. We are seeking a professional who is proactive, exceptionally organized, regulatory-minded, and comfortable taking ownership of assigned studies and responsibilities.
Attention to detail is essential. The Clinical Research Associate must be able to recognize when a regulatory document is missing, a signature is incomplete, training is expired, a visit falls outside a protocol window, an adverse event requires escalation, or documentation does not adequately support the research record—and take the appropriate steps to correct or escalate the issue.
The ideal candidate combines regulatory knowledge with strong clinical research operations skills and understands that patient safety, protocol compliance, documentation integrity, data quality, and timely communication are inseparable components of successful clinical trial execution.
Work Environment
This is a paid, in-person clinical research position within a fast-paced and collaborative medical research environment. The position provides opportunities for professional development, continued clinical research training, and increased responsibility as the research program grows.
Candidates must be flexible and able to work at both our Washington, DC and Annapolis, Maryland research locations depending upon patient schedules, study requirements, monitor visits, staffing needs, and operational demands.
Join our team and contribute to clinical research designed to advance medical knowledge, support innovative therapies, and improve patient outcomes.
Pay: $33.00 - $40.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Employee discount
- Health insurance
- Paid time off
- Vision insurance
Application Question(s):
- Are you located in the Metropolitan Area?
Education:
Experience:
- Clinical research: 2 years (Required)
- Regulatory reporting: 2 years (Required)
License/Certification:
Willingness to travel:
Work Location: In person
