Clinical Research Associate III/Senior Clinical Research Associate I
Avance Clinical · United States
- Hybrid
- Full-time
- $100,000 / year
- United States
Job highlights
- Conduct clinical trial operations per protocol and GCP.
- Manage site activities and documentation for drug development.
- Ensure regulatory compliance and data accuracy.
- Collaborate with teams and mentor junior staff.
- Travel up to 50% for site monitoring.
About the role
About Avance Clinical
Avance Clinical is a Contract Research Organisation offering specialized services to support drug development for the pharmaceutical and biotechnology industries. With founding roots dating back to the 1980s, we are experts in our field.
Why Join Avance Clinical?
We believe our people are our most important asset. We offer a fun, friendly work environment with a culture that values honesty and respect. We foster a strong sense of team, genuinely appreciating individuals while recognizing collective success. We are committed to creating a flexible work environment that supports work-life balance.
Job Summary
The Senior Clinical Research Associate (SCRA I) performs assigned trial-related duties to ensure trials are conducted in accordance with the protocol, company Standard Operating Procedures (SOPs), ICH GCP guidelines, and other applicable regulatory requirements. Responsibilities include service provision, support for departmental systems and procedures, reporting, and potentially mentoring junior team members.
Core Responsibilities
- Conduct site and investigator feasibility activities.
- Coordinate Human Research Ethics Committee submission requirements.
- Develop study-related documents or plans under supervision.
- Oversee and lead clinical team operations as Lead CRA for multi-site studies, including developing Clinical Monitoring Plans and reviewing Visit Reports.
- Perform all activities for 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, and follow-up letters.
- Monitor participant source data, review Investigator Site Files (ISF), perform Investigational Product accountability, and ensure adherence to protocol and ICH GCP.
- Raise data queries and work with site staff for timely resolution.
- Collect and ensure accurate filing of TMF documentation.
- Maintain effective site communication to manage study expectations and issues.
- Participate in audits and respond to observations.
- Ensure Serious Adverse Events are reported per protocol requirements.
- Provide guidance and mentoring to less experienced staff.
- Perform other duties as directed by Line Management.
Departmental Responsibilities
- Foster a healthy team culture and promote good morale.
- Maintain effective communication with other department members.
- Proactively identify and assist in mitigating departmental risks.
- Manage and track business-related expenses.
- Identify training needs and recommend actions.
- Contribute to the development of departmental SOPs.
- Participate in internal Quality Assurance activities.
Organisational Responsibilities
- Embrace Avance Clinical's core values.
- Commit to Avance Clinical training programs.
- Adhere to Avance quality systems.
- Take reasonable care for personal health and safety and that of others.
Note: Accountabilities may be altered according to changing position requirements.
Qualifications, Skills, And Experience
- Bachelor's degree in life sciences, pharmacy, nursing, or equivalent field.
- 3-4 years of previous CRA experience in a CRO or Pharma company.
- Formal ICH GCP training and working knowledge of ICH GCP Guidelines and regulatory requirements.
- Clear understanding of client confidentiality.
- Effective written and oral communication skills.
- Demonstrated ability to take initiative in problem-solving and exercise good judgment.
- Awareness of Privacy Legislation in the Clinical Trial environment.
- Ability to work under pressure in a multi-disciplinary team environment.
- Willingness to work in and support a positive and dynamic team culture.
- Ability to travel, with moderate interstate travel (up to 50%) required.
What We Offer
- Stimulating work
- Project diversity
- An intellectual challenge
- An agile & flexible workplace
- Opportunity to progress
- Stability
- Sense of community
- A leadership team committed to a common goal
- Flexible work options
- Great tools / tech to do your job
Key skills/competency
- Clinical Research Associate
- ICH GCP
- Protocol Compliance
- Site Monitoring
- Data Management
- Regulatory Requirements
- Clinical Trials
- Drug Development
- CRO Operations
- Pharmaceutical Industry
Skills & topics
- Clinical Research Associate
- Senior Clinical Research Associate
- CRA
- ICH GCP
- Clinical Trials
- Drug Development
- CRO
- Biotechnology
- Pharmaceutical
- GCP
- Site Monitoring
- Regulatory Compliance
- Life Sciences
- Protocol Management
- Data Management
- Healthcare
- Biopharma
- Clinical Operations
- Research
- Study Management
How to get hired
- Tailor your resume: Highlight your 3-4 years of CRA experience, ICH GCP training, and success in monitoring and regulatory compliance.
- Showcase your skills: Emphasize your communication, problem-solving, and ability to work under pressure in a team environment.
- Demonstrate flexibility: Mention your willingness to travel up to 50% and adapt to a dynamic team culture.
- Prepare for interviews: Be ready to discuss your experience with site feasibility, ethics committee submissions, and data query resolution.
Technical preparation
Review ICH GCP guidelines thoroughly.,Understand protocol development and review.,Practice raising and resolving data queries.,Familiarize with TMF filing requirements.
Behavioral questions
Describe a time you managed a challenging site.,How do you ensure client confidentiality?,Discuss your problem-solving approach.,How do you mentor junior team members?
Frequently asked questions
- What qualifications are essential for a Senior Clinical Research Associate at Avance Clinical?
- To be considered for the Senior Clinical Research Associate role at Avance Clinical, you'll need a Bachelor's degree in a life science field, at least 3-4 years of experience as a CRA in a CRO or Pharma company, and formal ICH GCP training. Strong communication, problem-solving skills, and the ability to travel are also crucial.
- What is the typical travel expectation for a Senior Clinical Research Associate at Avance Clinical?
- The Senior Clinical Research Associate role involves moderate interstate travel, potentially up to 50%. This travel is essential for performing site monitoring visits, including Pre-Study Visits, Study Initiation Visits, Interim Monitoring Visits, and Close-out Visits.
- Does Avance Clinical offer opportunities for professional growth for Senior Clinical Research Associates?
- Yes, Avance Clinical emphasizes career progression and offers an opportunity to progress within the company. You'll also benefit from stimulating work and project diversity, providing continuous learning and development.
- What kind of work environment can I expect as a Senior Clinical Research Associate at Avance Clinical?
- You can expect a fun, friendly, and dynamic team environment that values honesty and respect. Avance Clinical is committed to a flexible workplace, supporting a good work-life balance and fostering a strong sense of community.
- What are the key responsibilities of a Senior Clinical Research Associate I at Avance Clinical?
- Key responsibilities include conducting site feasibility, managing ethics committee submissions, developing study documents, overseeing clinical operations as Lead CRA (for multi-site studies), performing site monitoring visits (remote and onsite), ensuring regulatory compliance, managing data queries, and mentoring junior staff.
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