The Clinical Research Associate acts as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for the allocated sites.

Key Accountabilities:

Site Management 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 International Conference on Harmonization / Good Clinical Practices, 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 and manages various tasks in collaboration with other sponsor roles to achieve Site Ready

Participates and 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, closeout 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 Clinical Research Manager and Partner Line Manager

Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines

Team Development and Support

Contributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required

Supports and/or leads audits/inspection activities as needed

Performs co-monitoring visits where appropriate

Compliance with Parexel Standards

Complies with required training curriculum

Completes timesheets accurately as required

Submits expense reports as required

Updates CV as required

Maintains a working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements

Skills:

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 judgement

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, working solution-oriented manner

Performs root cause analysis and implements preventative and corrective action

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

Demonstrated high level of monitoring skill with independent professional judgement

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.

Demonstrates commitment to Customer focus

Works with high quality and compliance mindset

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

Knowledge and Experience:

Minimum 2 years of direct site monitoring experience in bio/pharma/CRO

Note: Specific monitoring and therapeutic area experience requirements may vary depending on the Country or study needs.

Education:

Bachelor’s degree preferred with a strong emphasis in science and /or biology

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