Broad Purpose
Avance Clinical is a Contract Research Organisation which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry.
The Clinical Research Associate II (CRA II) perform activities associated with the evaluation, initiation, monitoring and close out of clinical trials to ensure the trial is conducted in accordance with the protocol; company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements.
Core Responsibilities
* Conduct site and investigator feasibility activities.
* Perform all activities (preparation, execution, and follow-up) associated with onsite or remote Pre- Study Visits (PSV), Study Initiation Visits (SIV), Dose Witness Visits (DWV), Interim Monitoring Visits (IMV) and Close-out Visits (COV).
* Generate and maintain high quality confirmation letters, site visit reports, follow-up letters and other documentation related site monitoring and management to ensure compliance with ICH GCP, study protocol and regulatory requirements.
* Monitor participant source data, review Investigator Site Files (ISF), perform Investigational Product accountability, meet with site personnel, and ensure procedures are conducted in accordance with the protocol and ICH GCP.
* Raise data queries in the Case Report Form (CRF) where discrepancies are identified and work with site staff to ensure timely and accurate resolution.
* Collect TMF documentation from site and ensure accurate and timely filing as per SOP requirements.
* Maintain effective site communication to proactively manage on-going study expectations and issues.
* Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.
* Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.
* Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications.
Departmental Responsibilities
* Foster the on-going commitment to maintaining a healthy team culture and promoting good morale, by actively participating in regular Clinical Operations Team meetings.
* Maintain effective communication with other members of the department.
* Proactively identify risks related to departmental service provision and assist in their mitigation and resolution.
* Manage and track business related expenses as per company policy.
* Participate in internal Quality Assurance activities as required, including responding to internal audit findings.
Qualifications, Skills, and Experience
* Bachelor's level degree in life sciences, pharmacy, nursing, or equivalent field.
* Previous experience as a CRA in a CRO or Pharma company for at least 1 year.
* Formal ICH GCP training (desirable) and a well-developed knowledge of ICH GCP Guidelines and other applicable regulatory requirements.
* Clear understanding of the requirement to adhere strictly to client confidentiality.
* Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.
* Demonstrated ability to take initiative in problem solving and in exercising good judgment.
* Awareness of Privacy Legislation as it applies to the Clinical Trial environment (desirable).
* Ability to work under pressure in a multi-disciplinary team environment.
* Willingness to work in, and be supportive of, a positive and dynamic team culture.
* Ability to travel. Moderate level of interstate travel may be required (up to 50%).