The Clinical Research Associate is assigned to trial sites and is responsible for ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), as well as applicable regulations and guidelines from start-up through database lock. Responsibilities include working closely with Clinical Trial Manager and/or Site Managers to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement, training and mentoring of site staff and/or other CRAs. This is an in-house based position.

Required Qualifications

RN or BA/BS degree in clinical, science or health related field

Minimum of 3 years clinical trial monitoring experience

Alternatively, you should have an equivalent combination of education, training, and experience

Rheumatology/Immunology experience is preferred

Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.

Willingness to travel up to 60% of the time.

Good written and oral communication skills.

Primary Responsibilities

Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team. May evaluate the capability of site to successfully manage and conduct the clinical study.

Attends/participates in investigator meetings as needed.

Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/Wis and policies.

Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.

Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve study objectives.

Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.

Arranges for the appropriate destruction of clinical supplies

Conducts Source Document Review of appropriate site source documents and medical records

Ensures site staff completes the data entry and resolve queries within expected timelines.

Ensures accuracy, validity and completeness of data collected at trial sites

Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.

Maintains complete, accurate and timely data and essential documents in systems utilized for trial management

Fully documents trial related activities via confirmation letters, follow-up letters, visit reports, communication logs, and other required project documents as per SOPs. Writes visit reports and sends within 5 working days for review and approval. Complete follow-up letter to communicate relevant information and required corrective action to the investigator and their team. Promptly communicates relevant status information and issues to appropriate stakeholders.

Follows the corresponding Clinical Monitoring Plan for each assigned trial.

Education:

Bachelor's (Preferred)

Experience:

Clinical Trial Monitoring: 3 years (Preferred)

Work Location:

Hybrid (XBiotech office based).

XBiotech USA, Inc.

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Clinical Research Associate