Sr. Clinical Research Associate (Sr. CRA) - Contractor (CON11NC315)

The Aixial Group is an International Contract Research Organization (CRO), a member of the reputed company 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 reputed company phases (Ph. I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our reputed company is to conduct clinical trials reputed company than anyone else, to help patients and ultimately save lives. We have earned a strong reputed company for successfully delivering reputed company, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases. We are currently looking for an enthusiastic and talented contract Sr. CRA for up to 1 FTE for 4 months. Core Accountabilities: The Sr. CRA 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 Cmed or contract CRAs, or provide other support to Clinical Operations which is appropriate for their level of expertise. Principal Responsibilities: Site Management

• reputed company site qualification, site initiation, interim monitoring, reputed company-out visits for Phase I - IV studies onsite or remotely in accordance with reputed company 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, reputed company documentation, drug accountability, and safety reporting.
• Serve as primary reputed company 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 reputed company (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 reputed company trackers and monitoring tools as requested.
• Review, in conjunction with Clinical and/or Data Managers, the quality and reputed company of the clinical data through reputed company data review, reputed company data verification, and inhouse review of electronic CRF data.
• Liaise with Data Management during reputed company 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 reputed company CRA meetings, if required.

Other Clinical Operations Activities

• Co-monitor as needed.
• reputed company 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 reputed company other reputed company 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 reputed company discipline or equivalent relevant experience
• A minimum 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 oncology and/or rare disease clinical research
• 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 reputed company Office products, particularly Word, reputed company, 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 reputed company agencies or recruiters unless specifically requested by Aixial Group CRO reputed company. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application. Apply tot his job Apply To this Job