Clinical Research Associate
il y a 1 semaine
As part of a dynamic and passionate team, the Clinical Research Associate is the laboratory's ambassador to the centers, and the defender of the entire product portfolio.
He/she plays a key role in all phases of a study, and assumes overall responsibility for the conduct of clinical studies at assigned sites.
Responsibilities include, but are not limited to:
- 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 indepth 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 onsite monitoring & oversight activities using various tools to ensure: o Data generated at site are complete, accurate and unbiased.
- Subjects' right, safety and wellbeing 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 & nonvisit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study startup, study maintenance and study closeout.
- 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.
- 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 audit/inspection activities as needed.
- Performs comonitoring visits where appropriate.
- Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
CORE Competency Expectations:
- 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 judgment.
- Ability to understand and analyse data/metrics and act appropriately.
- Capable of managing complex issues, works in a solutionoriented manner.
- Performs root cause analysis and implements preventative and corrective action.
Behavioural Competency Expectations:
- Demonstrated high level of monitoring skill with independent professional judgement.
- Able to work highly independently across multiple protocols, sites and therapy areas.
- Positive mindset, growth mindset, capable of working independently and being selfdriven.
Experience Requirements:
- Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.
Educational Requirements:
Preferred: B.A./B.S. with strong emphasis in science and/or biology
Our offer:
- Full training and support for employees
- Career opportunities within the laboratory
- Very attractive package with target bonus, profitsharing, vacation vouchers
- Flexible working conditions
Search Firm Representatives Please Read Carefully
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:
R289487
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