Clinical Research Associate III
Avance Clinical · United States
- Hybrid
- Full-time
- $90,000 / year
- United States
Job highlights
- Monitor clinical trials for compliance.
- Perform site evaluation, initiation, monitoring, close-out.
- Ensure adherence to GCP and regulations.
- Mentor junior staff and manage site communication.
- Requires 2+ years CRA experience.
About the role
About Avance Clinical
Avance Clinical is a Contract Research Organisation (CRO) providing specialized services to support drug development within the pharmaceutical and biotechnology industries. With founding roots dating back to the 1980s, we are recognized experts in our field.
Why Join Avance Clinical?
We believe our people are our most important asset. We foster a fun, friendly work environment with a culture that values honesty and respect. We have a strong sense of team, genuinely appreciating individuals while celebrating collective success. We are committed to creating a flexible work environment that supports work-life balance.
Job Summary: Clinical Research Associate III
The Clinical Research Associate III (CRA III) is responsible for various aspects of clinical trials, including evaluation, initiation, monitoring, and close-out. This role ensures trials are conducted in compliance with the protocol, company SOPs, ICH GCP guidelines, and other regulatory requirements.
Core Responsibilities
- Conduct site and investigator feasibility assessments.
- Develop study-related documents and plans under Project Manager supervision.
- For multi-site studies, lead clinical team operations as the Lead CRA, including developing the Clinical Monitoring Plan and reviewing Visit Reports.
- Perform all visit activities (preparation, execution, follow-up) for Pre-Study Visits (PSV), Study Initiation Visits (SIV), Dose Witness Visits (DWV), Interim Monitoring Visits (IMV), and Close-out Visits (COV), whether onsite or remote.
- Generate and maintain high-quality confirmation letters, site visit reports, follow-up letters, and other site monitoring documentation, ensuring compliance with ICH GCP, study protocol, and regulatory requirements.
- Monitor participant source data, review Investigator Site Files (ISF), perform Investigational Product accountability, and meet with site personnel to ensure adherence to protocol and ICH GCP.
- Perform protocol reviews as requested.
- Raise data queries in the Case Report Form (CRF) and collaborate with site staff for timely and accurate resolution.
- Collect and ensure timely filing of TMF documentation from sites per SOP requirements.
- Maintain effective site communication to proactively manage study expectations and issues.
- Participate in sponsor or regulatory agency audits and respond to audit observations.
- Ensure timely reporting of Serious Adverse Events (SAEs) as per protocol requirements.
- 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
- Contribute to a positive team culture and high morale by participating in Clinical Operations Team meetings.
- Maintain effective communication within the department.
- Proactively identify and assist in mitigating risks related to departmental service provision.
- Manage and track business-related expenses according to company policy.
- Assist in the development of departmental SOPs as required.
- Participate in internal Quality Assurance activities and respond to audit findings.
Qualifications, Skills, and Experience
- Bachelor's degree in life sciences, pharmacy, nursing, or equivalent.
- Minimum of 2 years of experience as a CRA in a CRO or Pharma Company.
- Formal ICH GCP training and a working knowledge of ICH GCP Guidelines and applicable regulatory requirements.
- Clear understanding of client confidentiality requirements.
- Effective written and oral communication skills.
- Demonstrated ability to take initiative, problem-solve, and exercise good judgment.
- Awareness of Privacy Legislation relevant to clinical trials.
- Ability to work under pressure in a multi-disciplinary team environment.
- Willingness to support a positive and dynamic team culture.
- Ability to travel, with moderate interstate travel (up to 50%) required.
What We Offer
- Stimulating work with project diversity.
- Intellectual challenge.
- An agile and flexible workplace.
- Opportunity for career progression.
- Stability and a strong sense of community.
- A collaborative leadership team.
- Flexible work options.
- Access to great tools and technology.
Key skills/competency
- Clinical Research Associate
- Drug Development
- ICH GCP Guidelines
- Clinical Trials
- Site Monitoring
- Protocol Compliance
- Investigator Site Files
- Serious Adverse Events
- CRO Operations
- Regulatory Requirements
Skills & topics
- Clinical Research Associate
- CRA
- Contract Research Organisation
- CRO
- Drug Development
- Pharmaceutical Industry
- Biotechnology Industry
- ICH GCP
- Clinical Trials
- Site Monitoring
- Life Sciences
- Pharmacy
- Nursing
- Regulatory Affairs
- Data Management
- SOPs
- TMF
- SAE Reporting
- Remote Monitoring
- On-site Monitoring
- Investigator Support
- Protocol Review
- Quality Assurance
- Team Collaboration
- Problem Solving
- Client Confidentiality
How to get hired
- Tailor your resume: Highlight your 2+ years of CRA experience and ICH GCP knowledge.
- Showcase your skills: Emphasize problem-solving, communication, and ability to work under pressure.
- Demonstrate industry knowledge: Mention your understanding of drug development and regulatory requirements.
- Prepare for interviews: Be ready to discuss your experience with site monitoring and compliance.
- Express your fit: Convey your enthusiasm for Avance Clinical's team culture and flexible environment.
Technical preparation
Master ICH GCP guidelines and regulatory requirements.,Familiarize yourself with CRF and data query processes.,Understand TMF documentation requirements.,Practice site monitoring visit procedures.
Behavioral questions
Describe a time you managed a difficult site.,How do you handle pressure and deadlines?,Give an example of problem-solving initiative.,How do you ensure client confidentiality?
Frequently asked questions
- What is the required experience for a Clinical Research Associate III at Avance Clinical?
- The Clinical Research Associate III role at Avance Clinical requires a minimum of 2 years of experience as a CRA within a CRO or pharmaceutical company. This ensures candidates have a solid foundation in clinical trial monitoring and management.
- Does Avance Clinical offer flexible work arrangements for their CRAs?
- Yes, Avance Clinical is committed to creating a flexible work environment for its employees, supporting them in balancing their work commitments and personal needs. This includes offering flexible work options.
- What are the key responsibilities of a CRA III at Avance Clinical?
- Key responsibilities include site feasibility, conducting monitoring visits (PSV, SIV, IMV, COV), ensuring protocol and GCP compliance, reviewing site files, managing data queries, and mentoring junior staff. They also play a role in departmental responsibilities and quality assurance.
- What qualifications are necessary to become a Clinical Research Associate III at Avance Clinical?
- A Bachelor's level degree in life sciences, pharmacy, nursing, or an equivalent field is required. Additionally, formal ICH GCP training and a strong working knowledge of ICH GCP Guidelines and other applicable regulatory requirements are essential.
- Is there travel involved for the Clinical Research Associate III position?
- Yes, the Clinical Research Associate III role involves travel. A moderate level of interstate travel, potentially up to 50%, may be required for this position.
- What kind of team environment can I expect at Avance Clinical?
- Avance Clinical offers a fun, friendly work environment with a strong sense of team. They value honesty, respect, and collective success, fostering a positive and dynamic culture where individuals are genuinely appreciated.
- What does Avance Clinical specialize in?
- Avance Clinical is a Contract Research Organisation (CRO) specializing in providing services that support drug development for the pharmaceutical and biotechnology industries.
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