Senior CRA II (ICU Experience/Kidney or Renal)
Avance Clinical · United States
- Hybrid
- Full-time
- $95,000 / year
- United States
Job highlights
- Conduct clinical trials following protocols and GCP guidelines.
- Perform site visits and data monitoring.
- Ensure regulatory compliance and documentation.
- Mentor junior research staff.
- Travel up to 50% for site monitoring.
About the role
Senior Clinical Research Associate II (SCRA II) - ICU Experience/Kidney or Renal
Avance Clinical is a Contract Research Organisation providing specialised drug development services to the pharmaceutical and biotechnology industry.
Broad Purpose
The Senior Clinical Research Associate II (SCRA II) performs assigned trial duties, ensuring adherence to the protocol, company SOPs, ICH GCP guidelines, and other regulatory requirements. Responsibilities include service provision, departmental systems support, reporting, and potentially mentoring junior team members.
Core Responsibilities
- Conduct site and investigator feasibility activities.
- Coordinate Human Research Ethics Committee submissions.
- Develop study-related documents under Project Manager supervision.
- For multi-site studies, lead clinical team operations as Lead CRA, including developing the Clinical Monitoring Plan and reviewing Visit Reports.
- Perform and manage Pre-Study Visits (PSV), Study Initiation Visits (SIV), Dose Witness Visits (DWV), Interim Monitoring Visits (IMV), and Close-out Visits (COV) (preparation, execution, follow-up).
- Generate high-quality confirmation letters, site visit reports, follow-up letters, and other monitoring documentation in compliance with ICH GCP, study protocol, and regulatory requirements.
- Monitor participant source data, review Investigator Site Files (ISF), perform Investigational Product accountability, and ensure adherence to protocol and ICH GCP.
- Perform protocol reviews as requested.
- Raise and resolve data queries in the Case Report Form (CRF) with site staff.
- Collect and file TMF documentation accurately and timely per SOPs.
- Maintain effective site communication to manage expectations and issues proactively.
- Participate in sponsor or regulatory agency audits and respond to findings.
- Ensure Serious Adverse Events are reported per protocol.
- Provide guidance and mentoring to less experienced staff during co-monitoring and accompanied site visits.
- Perform other duties as directed by Line Management.
Departmental Responsibilities
- Foster a positive team culture and morale by participating in Clinical Operations Team meetings.
- Maintain effective communication with other department members.
- Proactively identify and assist in mitigating departmental service risks.
- Manage and track business-related expenses per company policy.
- Identify training needs and contribute to training programs for the Clinical Operations Team.
- Contribute to the development of departmental SOPs.
- Participate in internal Quality Assurance activities and respond to audit findings.
Organisational Responsibilities
- Embrace and display Avance Clinical core values at all times.
- Commit to Avance Clinical training programs.
- Adhere to Avance quality systems.
- Take reasonable care for personal health and safety and that of others.
Accountabilities may be altered based on changing requirements.
Qualifications, Skills, And Experience
- Bachelor's degree in life sciences, pharmacy, nursing, or equivalent.
- 4-6 years of CRA experience in a CRO or Pharma company.
- Formal ICH GCP training and working knowledge of ICH GCP Guidelines and regulatory requirements.
- Understanding of client confidentiality.
- Effective written and oral communication skills for client and stakeholder updates.
- Demonstrated initiative in problem-solving and good judgment.
- Awareness of Privacy Legislation in the Clinical Trial environment.
- Ability to work under pressure in a multi-disciplinary team.
- Willingness to support a positive and dynamic team culture.
- Ability to travel, with moderate interstate travel (up to 50%).
Relevant Working Conditions And Physical Demands
Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 50 lbs /23 kg. May involve prolonged periods in a stationary position. Mild exposure to outdoors may be necessary.
Key skills/competency
- Clinical Research Associate
- ICH GCP
- Clinical Monitoring
- CRF
- TMF
- Protocol Review
- Serious Adverse Events
- Investigator Site Files
- Site Feasibility
- Drug Development
Skills & topics
- Clinical Research Associate
- CRA
- ICH GCP
- Clinical Trials
- Drug Development
- Monitoring
- CRO
- Biotechnology
- Pharmaceutical
- Healthcare
How to get hired
- Tailor your resume: Highlight your 4-6 years of CRA experience and specific ICU/kidney/renal trial expertise. Emphasize your ICH GCP knowledge and problem-solving skills.
- Craft a compelling cover letter: Showcase your understanding of Avance Clinical's values and your ability to work in a dynamic team environment. Mention your willingness to travel.
- Prepare for interviews: Be ready to discuss your experience with site monitoring, data queries, regulatory compliance, and mentoring junior staff. Highlight your ability to work under pressure.
- Demonstrate relevant experience: Emphasize any experience with Human Research Ethics Committee submissions, TMF management, and Serious Adverse Event reporting.
Technical preparation
Review ICH GCP guidelines thoroughly.,Practice CRF data query resolution.,Familiarize with TMF and ISF requirements.,Study protocol review techniques.
Behavioral questions
Describe a challenging site relationship.,How do you handle protocol deviations?,Share an example of mentoring success.,How do you manage competing priorities?
Frequently asked questions
- What specific therapeutic areas does Avance Clinical focus on for Senior CRA II roles?
- While this role specifically mentions ICU experience and kidney or renal focus, Avance Clinical works across various therapeutic areas. Your transferable skills in clinical trial management and GCP compliance will be highly valued.
- What is the expected travel percentage for the Senior Clinical Research Associate II position at Avance Clinical?
- The role requires moderate interstate travel, potentially up to 50%. Candidates should be prepared for regular site visits and monitoring activities across different locations.
- What qualifications are essential for this Senior CRA II role?
- A Bachelor's degree in life sciences or a related field is required, along with 4-6 years of CRA experience. A strong understanding of ICH GCP guidelines and formal GCP training are also crucial.
- How important is mentoring experience for the Senior CRA II position?
- The job description indicates that mentoring junior team members is a potential responsibility. Demonstrating your ability to guide and support less experienced staff can be advantageous.
- What are the core responsibilities of a Senior Clinical Research Associate II at Avance Clinical?
- Core responsibilities include conducting site feasibility, managing ethics committee submissions, performing monitoring visits (remote and on-site), ensuring data accuracy, managing documentation, and ensuring compliance with protocols and GCP.
- What does Avance Clinical look for in terms of team culture fit for this role?
- Avance Clinical values a commitment to maintaining a healthy team culture, promoting good morale, and actively participating in team meetings. A positive and dynamic team culture is highly regarded.
- How does Avance Clinical handle Serious Adverse Event (SAE) reporting for Senior CRA IIs?
- Senior CRA IIs are responsible for ensuring Serious Adverse Events are reported (initial and follow-up) as per protocol requirements, a critical aspect of regulatory compliance.
- Can I apply for this Senior CRA II role if I don't have direct ICU or kidney/renal experience, but have strong CRA skills?
- While specific experience is preferred, a strong background as a CRA with excellent GCP knowledge and transferable skills in clinical trial management may still make you a competitive candidate. Highlighting your adaptability and quick learning ability would be beneficial.
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