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

Aixial Group•Greensboro, NC

21h

About The Position

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India. The CRO occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials in complex disease areas including oncology, immuno-oncology, and cell therapy, but also as a developer of its own technologies for managing clinical data. This is a very exciting time to join as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data. 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.

Requirements

Bachelor’s (or equivalent) degree in science, medical health, or related 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

Nice To Haves

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
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

Responsibilities

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
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.
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