Job Description
With support of Sr.CRA/CRA and/or CRA-Manager, acts as primary site contact and site manager
throughout all phases of a clinical research study, taking responsibility of allocated sites.
• 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 atsite 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 forstudy 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.
• Supports audit/inspection activities as needed.
• Performs co-monitoring where appropriate.
Competency Expectations:
• Fluent in Local Languages and English (verbal and written) and excellent
communication skills, including the ability to understand technical information.
Developing ability to present technical information with support.
• 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 CRA Guidelines and ability to work
within these guidelines.
• Hands on knowledge of Good Documentation Practices
• Developing skills in Site Management including management ofsite performance
and patient recruitment
• Developing level of monitoring skill and independent professional judgment.
• Good IT skills (Use of MS office, use of some clinical IT applications on computer,
tablet and mobile devices) and ability to adapt to new IT applications on various
devices.
• Works with high quality and compliance mindset.
• Capable of managing complex issues, solution-oriented approach.
• Ability to perform root cause analysis and implement preventative and corrective
action.
Behavioral Competency Expectations:
• Effective time management, organizational and interpersonal skills, conflict
management
• Able to work with other experienced research professions to develop skills 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, with support from Line Manager.
• Works effectively in a matrix multicultural environment. Ability to establish and
maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus.
• Positive mindset, growth mindset, capable of working independently and being selfdriven.
• Demonstrates and projects professional demeanor and communication consistent
with organizational policies and practices.
Experience and Educational Requirements:
- Associate’s degree, certificate or equivalent in a scientific / healthcare discipline together
with at least 3 years of relevant experience in the healthcare field.
Or
- Bachelor’s degree (or above) in a scientific / healthcare discipline together with at least 6
months of relevant experience in the healthcare field.
or
- Bachelor’s degree (or above) in a non-scientific/healthcare discipline together with at least
2 years of relevant experience in the healthcare field
**Required Skills: **
Accountability, Adverse Event Report, Clinical Evaluation Reports, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Good Clinical Data Management Practice (GCDMP), Investigations Training, Key Stakeholder Relationships, Protocol Adherence, Regulatory Compliance, Root Cause Analysis (RCA)
**Preferred Skills: **
Current Employees apply HERE
Current Contingent Workers apply HERE
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**Employee Status: **
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/11/2026
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