(Senior) Clinical Research Associate
- Experience Level
- Experienced (non-manager)
International, rapidly growing CRO is seeking a talented (Senior) Clinical Research Associate. The new incumbent will be accountable for study site management including site selection, initiation, routine monitoring, close-out and maintenance of study files. CRA also ensures the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.
Our Clients are a full service globally based Contract Research Organisation with in-depth experience of the most challenging therapeutic areas. They are seeking an experienced Clinical Research Associate, to come on board to assist with the monitoring of their growing portfolio of projects.
We are currently hiring for CRA / SCRA who will be dedicated to one Sponsor who is in Top 10 Pharmaceutical Companies. Interesting studies, possibilities to adjust to your expectations as per clinical career development.
Providing your application will give you access to recent job openings.
Duties associated with the role include:
- Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated 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 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 input 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 CRM, CRA‐M/PLM.
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.
• 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
• Is able to support and/or lead audit/inspection activities as needed
• Contribute to initiatives and projects adding value to the business
Performs co‐monitoring as appropriate
- B.A./B.S. preferred with strong emphasis in science and/or biology
- 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 & country clinical research law & guidelines.
- Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Demonstrated ability to mentor/lead
- Hands on knowledge of Good Documentation Practices
- Proven Skills in Site Management including independent management of site performance and patient recruitment
- Demonstrated high level of monitoring skill with independent professional judgment.
- 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
- Able to be a Lead study CRA to support CRM/COM
- Capable of managing complex issues, working solution-oriented.
- Performs root cause analysis and implements preventative and corrective action.
- Is able to mentor junior CRAs on process/study requirements and perform co‐monitoring visits where appropriate