Senior Clinical Research Associate

Simbec-Orion

14h

About The Position

We are looking for a Senior Clinical Research Associate to join our Clinical Operations team where you will be responsible for the setup, monitoring, close out of sites, budget negotiations, and liaising with relevant authorities to ensure approvals are in place. Will be involved with more complex studies and challenging sites to monitor the progress of clinical trials onsite or remotely, to ensure the trials are conducted, documented and reported in accordance with the protocol, standard operating procedures (SOPs), all applicable regulatory requirements and ICH-GCP. Will work closely with Clinical Trial Managers (CTMs), sponsors, project managers and other members of the study team to ensure study deliverables are met within the project timelines.

Requirements

Bachelor’s degree in Nursing, Life Sciences or Medical Sciences or equivalent work experience required
Previous experience as a Clinical Research Associate with strong demonstration of Clinical Research fundamentals
Good experience in CTMS, eTMF IXRS and EDC systems
Previous CRO experience
Excellent communication skills
Strong presentation skills
Proficiency in written and spoken English; fluent in host country language
Good knowledge of regional clinical research regulations and ICH-GCP
Multiple therapeutic experience and proven ability to gain in-depth protocol knowledge
Ability to establish/maintain good relationships with sites/colleagues/clients
Ability to make decisions independently / Strong problem-solving skills
Highly developed mentoring and motivational skills

Nice To Haves

Advanced degree (Masters, MD, PhD)
Competent in clinical trial planning and metrics management

Responsibilities

Contribute to site identification and feasibility activities.
Responsible for all aspects of study site management. (e.g. Training site staff, ensure supply of study material, IMP and trial documents, recruitment updates, etc...).
Responsible for collection and assessment of essential documents and perform reconciliation of Investigator Site File.
Conduct pre-study visits, site initiation visits site monitoring visits and site closeout visits per SOPs/WPDs.
Assesses IP accountability, dispensation, and compliance at the investigative sites.
Prepare accurate and timely visit reports in accordance with the monitoring plan and/or SOPs.
Collaborates with project functional leads as needed.
Attends internal and external project calls as requested and per budget to proactively provide required site updates.
Demonstrates working knowledge of applications and Systems (e.g. CTMS, eTMF, IVRS/IWRS and EDC).
Facilitates site audits and audit finding resolutions.
May supervise work of, or mentor, less experienced CRAs, based on Mentoring program.
Serve as an observational visit leader.
Provide feedback to management and cross-functional study team on any current or potential risks or problems affecting the conduct of the clinical trial.
Feedback on any areas requiring improvement within the department and involvement in initiatives such as updating SOPs, Work instructions and Processes.
Can be involved in other tasks as assigned by Management, CTMs and PMs.
Escalate in timely manner any issue related to Quality or Data integrity.