Clinical Research Associate – Oncology
Location
New Jersey
Posted
1 day ago
Salary
$96.2K - $151.4K / year
Seniority
Mid Level
Job Description
Clinical Research Associate – Oncology
MSD
• The role is accountable for performance and compliance for assigned protocols and sites in a country. • Under the oversight of the CRA-Manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. • Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. • Actively develops and expands the territory for clinical research, finding and developing new sites. • Participates in internal meetings and workstreams as SME for monitoring processes and Systems. • Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gains an in-depth understanding of the study protocol and related procedures. • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. • Participates & provides inputs on site selection and validation activities. • Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased and subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed. • Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required. • Supports and/or leads audit/inspection activities as needed. • Performs co-monitoring visits where appropriate. • Following the country strategy defined by CRD and/or CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
Job Requirements
- Associate's degree, certificate or equivalent in a scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field, including at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO.
- Or Bachelor’s degree (or above) together with at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO.
- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices.
- Proven Skills in Site Management including management of site performance and patient recruitment.
- Demonstrated high level of monitoring skill with independent professional judgment.
- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
- Ability to understand and analyze data/metrics and act appropriately.
- Capable of managing complex issues, works in a solution-oriented manner.
- Performs root cause analysis and implements preventative and corrective action.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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• accountable for performance and compliance for assigned protocols and sites • ensures compliance of study conduct with ICH/GCP and country regulations, our company's policies and procedures • acts as primary site contact and site manager throughout all phases of a clinical research study • develops and expands the territory for clinical research, finding and developing new sites • performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents • conducts site visits and maintains clear, comprehensive and accurate visit & non-visit contact reports • communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, regulatory documentation, site audits/inspections • identifies, assesses and resolves site performance, quality or compliance problems
• The role is accountable for performance and compliance for assigned protocols and sites in a country. • Under the oversight of the CRA-Manager the person ensures compliance of study conduct with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. • Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. • Actively develops and expands the territory for clinical research, finding and developing new sites. • Performs remote and on-site monitoring & oversight activities to ensure: • Data generated at site are complete, accurate and unbiased. • Subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits. • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. • Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gains an in-depth understanding of the study protocol and related procedures. • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. • Participates & provides inputs on site selection and validation activities. • Performs remote and on-site monitoring & oversight activities using various tools to ensure: • Data generated at site are complete, accurate and unbiased. Subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed. • Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
Role Description DAI seeks a Research and Learning Analyst for the Mastercard Strive USA program, funded by the Mastercard Center for Inclusive Growth (CFIG). Strive USA is designed to provide small businesses with the support they need to achieve sustainable growth and financial resilience. This program brings together community financial institutions (CFIs), networks of business support organizations (BSOs), and technology platforms to empower underserved small businesses to overcome common roadblocks. Over the course of this five-year project, Strive USA aims to reach five million small businesses, 600 CFIs and BSOs, and deploy $50 billion in growth capital. The Research and Learning Analyst will support the full Monitoring, Evaluation and Learning (MEL) cycle for the Strive USA grant portfolio including data collection, analysis, and reporting, as well as the implementation of research and learning activities. The Research and Learning Analyst will work with other team members to surface key insights and develop research and learning products addressing critical challenges in the small business support ecosystem. Responsibilities - Lead data collection, data quality, and data management for Strive USA’s program indicators. - Coordinate with CFIG M&E team for timely submission of impact reports and response to data requests. - Collaborate with Strive USA grants team for ongoing performance monitoring of grants programs. - Contribute to grant progress reports and briefing materials for the Mastercard Center for Inclusive Growth. - Oversee grantee outreach and follow-up related to implementation of learning activities. - Update and execute MEL plan including grantee learning activities and convenings. - Contribute to engagement with external research and evaluation firms. - Build Strive USA’s research and evidence base by conducting desk research and stakeholder interviews. - Gather, store, and analyze academic and grey literature; and federal, state, and local policy information. - Contribute to Strive USA’s thought leadership by drafting short commentaries, blogs, and knowledge products. - Support grantee collaboration and capacity building. - Provide research and logistical support to drive pipeline development as needed. - Additional and/or alternative responsibilities as deemed necessary. Qualifications - A bachelor’s degree and 3-5 years of relevant work experience preferably with philanthropic organizations, nonprofits, think tanks or research institutions. - Previous MEL experience preferred including demonstrated experience with data collection, cleaning, and analysis. - Ability to handle multiple tasks, shift priorities quickly, and adapt to a changing environment. - Excellent written, analytical, and verbal communication skills. - Well organized, detail-oriented, and self-directed. - Possessing sound technical skills, analytical ability, good judgment, and strong operational focus. - Demonstrated interest in community development finance, economic development, and/or racial equity. - Professional proficiency in spoken and written English. - Must be authorized to work in the United States without sponsorship. Preferred Qualifications - Data visualization experience ideal. - Demonstrated experience conducting independent research projects. Compensation For employees working in the United States, the full-time equivalent annual base salary for this position is expected to be between $60,000 – $75,000. Salary for part-time employees will be prorated based on actual hours worked. Actual offers will be based on several factors including, but not limited to, qualifications, relevant education, experience, skills, seniority, performance, and business or organizational needs. Equal Employment Opportunity All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or status as a protected veteran. DAI and its employees are committed to confronting discrimination in all forms, nurturing respect for our interpersonal relationships, and holding ourselves accountable for positive change within the company and in the communities, cultures, and countries in which we live and work. DAI is committed to attracting and retaining the best employees from all races, ethnicities, and backgrounds in our continued effort to become a better development partner. DAI upholds the highest ethical standards. We are committed to the prevention of sexual exploitation, abuse, and harassment as well as other ethical breaches. All our positions are therefore subject to stringent vetting and reference checks.
