Jobs at PharmaIN, Corp.

PharmaIN is seeking a highly motivated and collaborative Senior Clinical Research Associate (Sr. CRA) to join our growing Clinical Operations team.In this role, you will manage assigned aspects of small to medium‑sized clinical studies or support significant operational components of larger trials. You will work closely with the Clinical Trial Manager (CTM), Manager, Clinical Operations, cross‑functional internal teams, CROs, vendors, and clinical sites to ensure high‑quality execution, regulatory compliance, and on‑time delivery of clinical studies.This position reports to the Clinical Trial Manager, Clinical Operations, and may provide mentorship and training to entry‑level CRAs and Clinical Trial Assistants (CTAs).

Study Execution & Oversight

• Serve as a core member of the Clinical Operations study team, ensuring compliance with ICH GCP, PharmaIN SOPs, protocols, and regulations
• Support study execution across all phases: start‑up, enrollment, conduct, and closeout
• Oversee assigned aspects of site, vendor, and CRO management to ensure accurate and timely data collection
• Proactively identify and escalate risks related to timelines, milestones, resources, or study execution

Planning, Documentation & Processes

• Provide operational input into protocols, study designs, patient assessments, and site implementation strategies
• Contribute to development and review of study documentation (protocols, ICFs, CRFs, safety documents, monitoring tools, templates)
• Develop and adjust study workflows, operational plans, and resource strategies based on study progress and risk
• Partner with Clinical Quality to support audit and inspection readiness

CRO, Ventor & Site Management

• Support CRO and vendor selection (RFP reviews, bid defenses, proposal evaluations)
• Assist with study timelines, budgets, and financial tracking
• Participate in oversight of internal and CRO‑maintained Trial Master Files (TMFs)
• Support site identification, investigator selection, site contract and study budget negotiation, setup of site payment system and invoice review and approval
• Provide scientific regulatory support for new product introductions
• Perform site feasibility assessments
• Review and ensure all essential startup documents are complete prior to site activation
• May conduct site qualification and initiation visits and provide co-monitoring support for training or quality purposes
• Conduct sponsor oversight visits
• Train site staff on study protocol and procedures

Monitoring, Data & Supplies

• Support monitoring plan development and perform oversight activities
• Review Field CRA monitoring visit reports
• Collaborate with Data Management to support study‑specific data quality tools and metrics
• Coordinate with CMC and supply teams to support investigational product forecasting, accountability, and availability
• Assist with study drug, lab supply, and biological sample logistics

Regulatory, Safety & Collaboration

• Support IRB, regulatory submissions and IND amendments
• Participate in safety reviews, CSR evaluations, and Safety Review Committee or IDMC activities as needed
• Maintain complete regulatory and site communication files
• Mentor CRAs and CTAs; support onboarding and hiring efforts
• Contribute to departmental initiatives, process improvements, SOPs, and templates.

Education & Experience

• Bachelor’s degree in a relevant field, nursing degree, or equivalent experience
• 4+ years of experience as a CRA, including field monitoring experience, within the pharmaceutical, biotech or CRO environments
• 2+ years of sponsor‑side experience preferred
• Experience in site‑level trial management
• Experience supporting Phase 1–3 clinical trials; multinational experience a plus

Technical & Regulatory Expertise

• Strong knowledge of ICH, GCP, CFR, and GDPR/data privacy
• Experience in oncology, immuno‑oncology, hematology, or liver disease preferred
• Exposure to complex or innovative trial designs (e.g., basket or adaptive trials)
• Familiarity with CTMS, eTMF, IRT, eCOA, central labs, imaging vendors, and data management systems

Skills & Competencies

• Strong analytical, organizational, and problem‑solving skills
• Ability to analyze metrics and drive continuous improvement
• Excellent written and verbal communication skills
• Collaborative mindset with experience working in cross‑functional, global teams
• High attention to detail and strong time‑management skills
• Comfortable working in a hybrid, fast‑paced environment
• Proficiency with MS Office; Smartsheet or MS Project experience a plus.