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Clinical Operations Manager – Traveling CRC Team
Alcanza Clinical Research. Coordinate and execute clinical research support at various site locations.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research coordination, ensuring compliance with GCP, FDA regulations, and SOPs while managing site performance and team dynamics. Proficient in project management, stakeholder communication, and risk mitigation to achieve study milestones and maintain data quality.
Highest-signal resume keywords
Clinical Research CoordinationGCP ComplianceProject ManagementStakeholder ManagementRisk Mitigation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Research ExperienceData Quality ManagementEDC Data EntryPatient ScreeningProtocol ComplianceSOP AdherenceTyping 40+ WPMMicrosoft Applications ProficiencyElectronic Health RecordsBasic Laboratory Procedures
Soft Skills
Excellent CommunicationOrganizational SkillsProblem-Solving AbilitiesAttention to DetailSelf-Motivated
Industry Keywords
HIPAA ComplianceClinical ProtocolsStudy DeliverablesSite ManagementTravel Requirements
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Coordinate and execute clinical research support at various site locations.
- Manage and support a high-performing traveling team to enhance efficiencies, ensure patient safety and protocol/GCP/regulatory compliance, and meet targets.
- Collaborate with Study Delivery, Operations, Strategy, and Training leaders to coordinate delivery expectations, milestones, and quality data for sponsors.
- Oversee resource allocations, site assignments, team output, performance, study deliverables, risks, timelines, quality, and budget.
- Support site performance goals, identify and resolve issues, and ensure data quality.
- Assist with staff training on clinical systems, protocols, CRF completion, SOPs, GCP, IATA, clinical plans, and guidelines.
- Oversee assigned site staff, performance, compliance, timecards, pay, absences, orientation, and training.
- Conduct patient screening, consents, follow-up visits, source documentation, EDC data entry and query responses, vital signs, ECGs, and basic laboratory procedures as required by protocol.
- Request and track medical records; maintain logs, charts, supplies, and source documents.
- Schedule study visits, conduct appointment reminders, monitoring visits, and timely issue resolution.
- Ensure investigator review of study reports and patient results; file SAE/deviation reports; document adverse events and report non-compliance.
- Complete study start-up activities and required training and documentation.
- Ensure adherence to SOPs, GCP, FDA regulations, company policies, and procedures.
- Collaborate with investigators, site teams, and support teams to meet goals and timelines.
- Propose and implement risk mitigations; participate in and present at management, production, and site meetings.
- Travel up to 100% as required.
Requirements
What you’ll need- An associate’s degree and a minimum of 3 years of clinical research experience, or an equivalent combination of education and experience, is required.
- 1+ years of management experience required.
- Proficiency with Microsoft applications, email, electronic health records, web applications, and typing 40+ wpm.
- Strong project management and organizational skills.
- Ability to manage multiple priorities and timelines.
- Excellent communication and stakeholder management.
- Strong problem-solving and risk mitigation abilities.
- Strong organizational skills and attention to detail.
- Well-developed written and verbal communication skills.
- Professional, respectful, self-motivated, and strong work ethic.
- High degree of integrity and dependability.
- Ability to work under minimal supervision, identify problems, and implement solutions.
- Ability to handle highly sensitive information confidentially and professionally in compliance with HIPAA guidelines.
- Up to 50% travel, as needed.
- Bi-lingual (English / Spanish) proficiency is a plus.
Benefits
Comp & perks- Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
- Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.