The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India.
The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases.
We are currently looking for a Senior Clinical Research Associate. This is a freelance role for up to 0.1 FTE. This position is remote and can be based anywhere in Bulgaria.
Core Accountabilities:
The Clinical Research Associate is responsible for site management and monitoring activities associated with clinical studies. This position may be assigned to monitor a specific study or studies, co-monitor with other CRAs, assist in the assessment of Aixial or contract CRAs, or provide other support to Clinical Operations which is appropriate for their level of expertise.
Principal Responsibilities:
Site Management
- Perform site qualification, site initiation, interim monitoring, close-out visits for Phase I - IV studies onsite or remotely in accordance with current ICH GCP guidelines, local regulatory requirements and appropriate SOPs.
- Confirm investigator adherence to ICH GCP, local regulatory requirements and to the protocol procedures.
- Adhere to the project plans, as applicable, for assigned studies.
- Complete and submit timely site visit reports per the monitoring plan/SOPs.
- Verify investigator maintenance of study documentation throughout the life of the study including essential documents, Investigator Site File, source documentation, drug accountability, and safety reporting.
- Serve as primary point of contact for assigned sites establishing and maintaining a good working relationship with site staff.
- Discuss, review, and document patient recruitment strategies with assigned sites.
- Work with Project Leader (PL), and/or Clinical Team Lead (CTL)/Clinical Trial Manager (CTM) to ensure that clinical monitoring activities are conducted on time, in accordance with the monitoring plan.
- Support assigned sites with vendor issues (e.g., Central Laboratory, IXRS, imaging, etc.) as they arise.
- Provide any additional training as identified throughout the study (e.g., protocol amendment, query trends) to site staff as needed.
- Work with site staff on timely data entry and query resolution
Study Management
- Assist in the development of study related trackers and monitoring tools as requested.
- Review, in conjunction with Clinical and/or Data Managers, the quality and integrity of the clinical data through source data review, source data verification, and inhouse review of electronic CRF data.
- Liaise with Data Management during all stages of a study to assist with query resolution as required.
- Assist the PL, and/or CTM/CTL with updating study metrics and compiling status reports.
- Assist with training of CRAs.
- Participate in study team meetings as required.
- May lead CRA meetings, if required.
Other Clinical Operations Activities
- Co-monitor as needed.
- Perform onsite or remote visits to assess CRA performance.
- Provide additional support to Clinical Operations staff as needed.
- Participate in department initiatives to enhance Clinical Operations
Additional
The above job description in no way states or implies these duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.
The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company.
Essential Work Experience, Qualifications and Knowledge:
- Bachelor’s (or equivalent) degree in science, medical health, or related discipline or equivalent relevant experience
- English and Bulgarian are required
- A minimum of five years of clinical monitoring experience in the Pharmaceutical/CRO industry
- Good clinical and therapeutic knowledge with understanding of medical and pharmaceutical industry terminology
- Excellent oral and written communication skills
- Strong knowledge of ICH-GCP guidelines and applicable regulations
Desirable Work Experience, Qualifications and Knowledge:
- Medical professional with experience in clinical research
- Experience in different therapeutical areas
- Proactive problem-solving skills
- Interpersonal and organizational skills with strong attention to detail
Technical
- An understanding of physiology, pharmacology, clinical study objectives and the drug development process
- Excellent computer skills
- Skills in working with Microsoft Office products, particularly Word, Excel, PowerPoint
For more information on Aixial Group recruitment and consideration for other opportunities, please review the recruitment statement on our careers page - https://www.aixialgroup.com/join-us/
Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by Aixial Group CRO Talent Acquisition. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.
