Simbec-orion is a responsive and agile full-service cro, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseasesPerfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers headed up by a centralised leadership team.
With a focus on tailormade and scalable solutions, well adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectivesBecause our goal is the same as theirs; to improve patients lives.
Summary of the position:
We are looking for a clinical research associate iii to join our clinical operations departmentYou will be based remotely in the us.
Experienced clinical research professional who is responsible for the setup of sites, budget proposals, and liaising with relevant authorities to ensure approvals are in placeWill 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-gcpWill work closely with sponsors, project managers and other members of the study team (ctls) to ensure study deliverables are met within the project timelines.
Key accountabilities:
Contribute to site identification and feasibility activities
Responsible for all aspects of study site management(egTraining 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.
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.
Demonstrates working knowledge of applications and systems (e.gCtms, etmf, ivrs/iwrs and edc).
Facilitates site audits and audit finding resolutions.
May supervise work of, or mentor, less experienced cras.
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, ctls and pms.
Minimum requirements:
Essential:
Bachelors degree in nursing, life sciences or medical sciences or equivalent work experience required
Experienced clinical research associate
Excellent communication skills
Proficiency in written and spoken english; fluent in host country language
Good knowledge of european 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
Desirable:
Previous cro experience
Good experience in ctms, etmf ixrs and edc systems
Advanced degree (masters, md, phd)
Experience as a senior clinical research associate
Strong presentation skills
Competent in clinical trial planning and metrics management
Job profile - clinical research associate iii.pdf
Simbec-orion is an equal opportunity employerSimbec-orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
