Clinical Research Associate (CRA) - FSP

Parexel International Corporation

Multiple Locations

Job Title: Clinical Research Associate (CRA)

Position Purpose :

The Clinical Research Associate (CRA) will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Organizational Relationships :

Reports to E xecuPharm (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 and IRB/IECs and Regulatory Authorities in support of assigned sites

I nteract with internal and external stakeholders (study sites, vendors, committees, etc.) in support o f clinical study objectives.

Primary Duties:

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 C linical R esearch Associate-Manager (CRAM)/Clinical Research Manager (CRM) , P artner Line Manager (PLM)

Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines

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

Supports and/or leads audits/inspection activities as needed

Performs co-monitoring visits where appropriate

Experience or ability to support and/or lead audit/inspection activities as needed

Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training

Adheres to EP and Client SOPs and processes

Skills and Education :

B.A./ B.S. preferred with a strong emphasis in science and /or biology

Minimum 2 years of direct site management (monitoring) experience in bio/pharma/CRO required

Note: No compromise on minimum monitoring experience however specific monitoring and therapeutic area experience requirements may vary depending on the Country or study needs

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 skil ls in Site Management including management of site performance and patient

recruitment

Demonstrated high level of monitoring skill with independent professional judgement

Good IT skill s (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

Performs root cause analysis and implements preventative and corrective action

Effective time management , organizational and interpers onal skills, conflict management, problem solving skills

Demonstrated high level of monitoring skill with independent professional judgement

Able to wo rk highly independently across multiple protocols, sites, and therapy areas

High sense of accountability / urgency

Ability to set priorities and handle multiple tasks simultaneo usly 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 s elf-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


2022-08-16 00:05:19


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