PXL FSP has an exciting opportunity for a Sr. CRA!
Job Title: Senior Clinical Research Associate (SCRA)
The Senior Clinical Research Associate (SCRA) 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.
Reports to ExecuPharm (EP) assigned Line Management with day-to-day direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure.
Works in partnership internally with Global Clinical Trial Operations (GCTO) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, Headquarter (HQ) functional areas and externally with vendors, Institutional Review Boards, Institutional Ethics Committees and Regulatory Authorities in support of assigned 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 Good Clinical Practice
(GCP) / International Council for Harmonization (ICH), 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 Clinical Research Manager(CRM) and Partner Line Manager (PLM),
Manages and maintains information and documentation in Clinical Trial Management System (CTMS),Electronic Trial Master File (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.
Mentors / buddies junior CRAs on process/study requirements.
Contributes to initiatives and projects adding value to the business.
Performs co-monitoring as appropriate.
Completes training assigned by Client and/or ExecuPharm (EP), as necessary, including general
training requirements, SOPs, and system and process related training.
Adheres to EP and Client SOPs and processes.
Education and Certification:
B.A./B.S. preferred with a strong emphasis in science and /or biology.
Skills and Experience:
Minimum 4 years of direct site management (monitoring) experience in bio/pharma/CRO.
Note: No compromise on minimum monitoring experience however specific monitoring or therapeutic experience/requirements may vary depending on the Country or study needs.
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
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.
Fluent in local languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
Ability to travel domestically and internationally approximately 65%-75% of working time.
Expected travelling ~2-3 days/week.
Current driver's license required.