Senior CRA II (ICU Experience/Kidney or Renal)

Broad Purpose Avance Clinical is a Contract Research Organisation which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry. The Senior Clinical Research Associate II (SCRA II) performs assigned trial related duties and functions ensuring the trial is conducted in accordance with the protocol; company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements. Responsibilities include service provision, departmental systems and procedures support and reporting and may include mentoring of junior team members. Core Responsibilities

• Conduct site and investigator feasibility activities.
• Coordinate Human Research Ethics Committee submission requirements to completion.
• Develop study-related documents or plans under the supervision of the study Project Manager.
• For a multi-site study, oversee and lead the operations of the clinical team as the Lead CRA including development of Clinical Monitoring Plan, study-specific annotated report, reviewing Visit Reports.
• 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.
• Perform protocol review as requested.
• 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.
• Provide guidance and mentoring to less experienced staff during co-monitoring visits and facilitating accompanied site visits.
• 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.
• Identify training needs of the Clinical Operations Team and provide recommendations for and participate in delivery of appropriate training actions and programs.
• Contribute to the development of departmental SOPs as required.
• Participate in internal Quality Assurance activities as required, including responding to internal audit findings.

Organisational Responsibilities

• Embrace the core values of Avance Clinical and endeavor to display those attributes at all times with clients and staff alike.
• Commit to Avance Clinical training programs.
• Adhere to Avance quality systems.

All staff are required to take reasonable care for their own health and safety and that of other personnel who may be affected by their conduct. The accountabilities as specified above may be altered in accordance with the changing requirements of the position. 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 4-6 years.
• Formal ICH GCP training and a working 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