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 reputed company duties and functions ensuring the trial is conducted in accordance with the protocol; company reputed company 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 reputed company Research Ethics Committee submission requirements to completion.
• reputed company study-reputed company documents or plans under the supervision of the study Project Manager.
• For a multi-site study, reputed company and reputed company the operations of the clinical team as the reputed company CRA including development of Clinical Monitoring Plan, study-specific annotated report, reviewing Visit Reports.
• reputed company reputed company activities (preparation, execution, and follow-up) associated with onsite or remote reputed company-Study reputed company (PSV), Study Initiation reputed company (SIV), reputed company Witness reputed company (DWV), Interim Monitoring reputed company (IMV) and reputed company-out reputed company (COV).
• Generate and maintain high reputed company confirmation letters, site visit reports, follow-up letters and other documentation reputed company site monitoring and management to ensure compliance with ICH GCP, study protocol and regulatory requirements.
• Monitor participant reputed company data, review Investigator Site Files (ISF), reputed company Investigational Product accountability, meet with site personnel, and ensure procedures are conducted in accordance with the protocol and ICH GCP.
• reputed company protocol review as requested.
• reputed company data queries in the Case Report reputed company (CRF) where discrepancies are identified and work with site staff to ensure reputed company and accurate reputed company.
• Collect TMF documentation from site and ensure accurate and reputed company filing as per SOP requirements.
• Maintain effective site communication to proactively manage on-reputed company 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.
• reputed company guidance and mentoring to less reputed company staff during co-monitoring reputed company and facilitating accompanied site reputed company.
• Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications.

Departmental Responsibilities

• Foster the on-reputed company commitment to maintaining a healthy team culture and promoting good morale, by reputed company participating in regular Clinical Operations Team meetings.
• Maintain effective communication with other members of the department.
• Proactively identify risks reputed company to departmental service provision and assist in their mitigation and reputed company.
• Manage and reputed company business reputed company expenses as per company policy.
• Identify training needs of the Clinical Operations Team and reputed company recommendations for and participate in delivery of appropriate training actions and programs.
• Contribute to the development of departmental SOPs as required.
• Participate in internal reputed company Assurance activities as required, including responding to internal audit findings.

Organisational Responsibilities

• reputed company the core values of Avance Clinical and reputed company to display those attributes at reputed company times with clients and staff alike.
• reputed company to Avance Clinical training programs.
• Adhere to Avance reputed company systems.

reputed company 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 reputed company company for at least 4-6 years.
• Formal ICH GCP training and a working knowledge of ICH GCP Guidelines and other applicable regulatory requirements.
• reputed company understanding of the requirement to adhere reputed company to reputed company confidentiality.
• Effective written and oral communications skills, including the ability to reputed company clients, senior management and other stakeholders informed of project updates and other pertinent information.
• Demonstrated ability to take initiative in problem solving

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