PXL FSP has an exciting opportunity for a Senior CRA !

The Senior Clinical Research Associate is responsible for the following: 

Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of 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 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 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.

Team Development and Support

• 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.

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

• Contributes to initiatives and projects adding value to the business

• Performs co-monitoring as appropriate

Compliance with Parexel Standards 

• Comply with required training curriculum

• Complete timesheets accurately as required

• Submit expense reports as required

• Update CV as required

• Maintain 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

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

• Hands on knowledge of Good Documentation Practices

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

• Demonstrated ability to mentor/lead

• Proven skills in Site Management including independent 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

• 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

• 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

• 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

• Ability to travel domestically and internationally approximately 65%-75% of working time • Expected travelling ~2-3 days/week

• Current driver’s license required

Knowledge and Experience:

• Minimum 4 years of direct site management (monitoring) experience in bio/pharma/CRO Note: Specific monitoring or therapeutic 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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