高级临床研究助理（CRA）

Job Description
Sr CRA- Responsibilities

• 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: o Data generated at site are complete, accurate and unbiased. o 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 internally 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 strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.

• Supports and/or leads audit/inspection activities as needed.

• Following the country strategy defined by CRD and CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

• Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.

• Could perform Quality control visits if delegated by other roles and trained appropriately.

CORE Competency Expectations:

• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.

• Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

• Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

• Demonstrated ability to mentor/lead.

• Hands on knowledge of Good Documentation Practices.

• Proven Skills in Site Management including independent 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, also in a virtual environment.

• Experience with conducting site motivational visit designed to boost site enrollment.

• Capable of managing complex issues, works in a solution-oriented manner.

• Performs root cause analysis and implements preventative and corrective action.

• Capable of mentoring junior CRAs on process/study requirements and is able to perform co- monitoring visits where appropriate.

Behavioral Competency Expectations:

• Demonstrates commitment to Customer focus.

• Works with high quality and compliance mind-set.

• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.

• Able to work highly independently across multiple protocols, sites and therapy areas.

• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.

• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

• Positive mindset, growth mindset, capable of working independently and being self-driven.

• Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

Experience and Educational Requirements:

• Bachelor’s degree (or above) with at least 4 years of direct site management (monitoring) experience in a bio / pharma / CRO.

• 7 years of relevant experience in the healthcare field, including at least 4 years of direct site management (monitoring) experience in bio / pharma / CRO.

Required Skills:
Adaptability, Adaptability, Clinical Site Management, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, Competency Management, Conflict Management, Cross-Cultural Awareness, Cultural Awareness, Customer Centricity, Decision Making, Document Management, Growth Mindset, ICH GCP Guidelines, Matrix Management, Multitasking, Patient Recruitment, Product Information, Regulatory Compliance, Relationship Building {+ 6 more}Preferred Skills:
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Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
75%Flexible Work Arrangements:
RemoteShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
naJob Posting End Date:
09/25/2026
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Originally posted on Himalayas