Note: The job is a remote job and is open to candidates in USA. Spaulding Clinical Research, LLC is seeking a Senior Clinical Research Associate (Senior CRA) who will be responsible for performing monitoring and site management activities for clinical research studies. The role involves ensuring compliance with study protocols and regulations while overseeing site conduct, documentation quality, and issue resolution.
Responsibilities
- Perform site monitoring visits, including site selection, site initiation, interim monitoring, and close-out visits, in accordance with contracted scope of work, monitoring plans, project requirements, Good Clinical Practice, applicable regulations, and sponsor expectations
- Review study conduct, source documentation, case report forms, regulatory documents, essential documents, and applicable study records for accuracy, completeness, timeliness, and protocol compliance
- Verify that study activities are conducted in accordance with protocol requirements, informed consent, GCP, applicable regulations, sponsor expectations, and Spaulding Clinical SOPs
- Identify, document, communicate, and escalate protocol deviations, documentation deficiencies, quality concerns, participant safety concerns, and operational risks in a timely manner
- Support timely resolution of monitoring findings, data discrepancies, action items, audit observations, and study team follow-up items
- Maintain a strong working knowledge of Phase I unit operations, clinical pharmacology procedures, study-specific requirements, source documentation expectations, and sponsor delivery expectations
- Support review of study-specific tools, worksheets, source templates, visit schedules, and documentation practices to promote consistency, completeness, and inspection readiness
- Participate in study meetings, sponsor calls, internal project meetings, and cross-functional discussions as the CRA representative or clinical operations quality resource
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations, questions, action items, and issues
- Evaluate the quality and integrity of study site practices related to proper protocol conduct, participant safety, data integrity, informed consent, and adherence to applicable regulatory requirements; escalate quality issues as appropriate
- Work with sites and study teams to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability and support enrollment goals
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution; may support the study start-up phase as assigned
- Maintain current knowledge of Good Clinical Practice, ICH guidelines, FDA regulations, applicable laws, ethical standards, and internal SOPs relevant to clinical trial conduct
- Review assigned protocols, amendments, informed consent documents, manuals, monitoring plans, and study-specific instructions to ensure thorough understanding of study requirements
- Support protocol training and study readiness activities by helping confirm that appropriate staff understand study-specific documentation, timing, procedural, and escalation requirements
- Partner with Quality Assurance and operational leaders to support audit readiness, inspection readiness, CAPA activities, root cause analysis, and quality improvement efforts as needed
- Ensure clinical research documentation supports sponsor review, audits, regulatory inspections, and internal quality expectations
- Recognize and escalate clinical practice concerns, participant safety issues, consent concerns, data integrity concerns, and potential compliance risks promptly and professionally
- Evaluate study documentation and data collection practices to help ensure accurate, attributable, legible, contemporaneous, original, and complete records
- Support data cleaning activities by assisting with query review, source-to-database verification, discrepancy follow-up, and communication with study team members
- Track assigned action items, findings, risks, and documentation issues through resolution using applicable tools, trackers, and systems
- Prepare accurate monitoring reports, visit summaries, follow-up letters, action item trackers, and other CRA deliverables in accordance with timelines and quality standards
- Support Trial Master File and/or study file completeness by reviewing essential documents and identifying missing, incomplete, or outdated documentation
- Ensure copies and/or originals, as required, of site documents are available for filing in the Trial Master File and verify that the Investigator's Site File is maintained in accordance with Good Clinical Practice and applicable regulatory requirements
- Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans by submitting regular monitoring visit reports, generating follow-up letters, and completing other required study documentation within required timelines
- Assist Project Management and study teams with study startup, conduct, closeout, and lessons-learned activities as assigned
- Partner with Project Management to support study timelines, risk management, sponsor communication, issue escalation, and successful project delivery
- Collaborate and liaise with study team members, assigned sites, sponsors, vendors, and functional departments to support project execution, issue resolution, and timely completion of study deliverables
- As applicable, support development of project subject recruitment plans on a per-site basis and provide input regarding recruitment risks, site performance trends, and mitigation strategies
- As applicable, support site financial management according to executed clinical trial agreements, including tracking site payment status, reviewing site/investigator payment-related documentation, and retrieving invoices according to applicable requirements
- Collaborate with Clinical Operations, Regulatory, Recruitment, Data Management, Pharmacy, Laboratory, Biometrics, Contracts, Finance, and other departments to support coordinated study execution
- Communicate professionally with sponsors, monitors, vendors, auditors, and internal stakeholders regarding CRA activities, documentation expectations, findings, risks, and follow-up needs
- Provide clear, timely, and solution-oriented communication regarding study status, monitoring outcomes, documentation gaps, and compliance concerns
- Support sponsor visits, sponsor audits, regulatory inspections, bid defense preparation, project kickoffs, governance discussions, and study closeout activities as requested
- Serve as a senior resource for CRA practices, Phase I documentation expectations, monitoring standards, GCP interpretation, and study execution quality
- Mentor, train, and provide guidance to CRA staff, clinical research staff, and cross-functional team members on study documentation, monitoring expectations, and escalation practices
- Identify opportunities to improve CRA processes, monitoring tools, templates, checklists, documentation quality, workflow efficiency, and inspection readiness
- Assist with development, implementation, and refinement of CRA tools, training materials, SOP-related workflows, and best practices
- Demonstrate professionalism, accountability, sound judgment, urgency, and leadership in interactions with staff, sponsors, vendors, participants, and external partners
- May act as lead CRA or primary CRA contact for assigned studies, complex projects, sponsor engagements, or coverage needs
Skills
- Ability to read, write, and interpret the English language
- Strong working knowledge of clinical research operations, GCP, FDA regulations, ICH guidelines, informed consent requirements, and clinical trial documentation standards
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements, Good Clinical Practice, and ICH guidelines
- Good therapeutic area and protocol knowledge as provided through company, sponsor, and study-specific training
- Demonstrated knowledge of CRA monitoring practices, source documentation review, essential document review, protocol deviation identification, issue escalation, and follow-up practices
- Understanding of Phase I clinical pharmacology unit operations, including inpatient/outpatient study conduct, protocol-driven procedures, visit schedules, sample collection timing, safety assessments, and data integrity expectations
- Excellent attention to detail and ability to produce accurate, complete, and timely documentation
- Strong analytical, problem-solving, organizational, and time management skills
- Ability to manage multiple competing priorities and meet deadlines in a fast-paced regulated environment
- Professional written and verbal communication skills, including ability to interact effectively with sponsors, auditors, vendors, investigators, study staff, and cross-functional colleagues
- Ability to identify risks, escalate concerns appropriately, and drive action items to resolution
- Demonstrated professionalism, sound judgment, accountability, discretion, and commitment to quality
- Ability to mentor, train, and guide less experienced staff
- Proficient computer skills, including Microsoft Word, Excel, PowerPoint, Outlook, clinical trial systems, electronic data capture systems, eTMF/CTMS tools, and other applicable technologies
- Bachelor's degree in a scientific discipline, healthcare, nursing, clinical research, or a related field preferred; equivalent combination of education, training, and relevant clinical research experience may be accepted in lieu of degree
- Minimum of 2 years of on-site monitoring experience required; additional progressive CRA, monitoring, clinical operations, or study oversight experience preferred for Senior CRA level
- Experience supporting Phase I-III, clinical pharmacology, CRO, pharmaceutical, biotech, academic research, or clinical research unit studies
- Strong knowledge of clinical trial conduct, applicable clinical research regulatory requirements, Good Clinical Practice, ICH guidelines, FDA regulations, source documentation, protocol compliance, and essential document requirements
- Demonstrated experience identifying and escalating protocol deviations, documentation deficiencies, quality risks, and participant safety concerns
- Ability to work independently, manage multiple priorities, and communicate effectively with sponsors and cross-functional teams
- CCRA, CCRP, ACRP-CP, SOCRA, or other relevant clinical research certification
- Prior Senior CRA, Lead CRA, monitoring, or audit-readiness experience in a Phase I clinical pharmacology unit or CRO environment
- Experience with cardiac safety, thorough QT, first-in-human, SAD/MAD, bioequivalence, drug-drug interaction, food effect, renal/hepatic impairment, or other clinical pharmacology study designs
- Experience with EDC, CTMS, eTMF, electronic source, clinical trial management tools, and sponsor portals
- Experience mentoring CRA staff or training clinical research personnel
- Experience supporting sponsor audits, regulatory inspections, CAPAs, root cause analysis, and process improvement initiatives
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