What are the responsibilities and job description for the Manager, CRA Quality Assurance & Training position at Therapeutics Inc.?
Who Are We?
Founded in 1997 and built upon 27 years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego’s Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients.
Who Are You?
You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important so you take pride in delivering great work. You believe anything worth doing, is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently.
If this sounds like you, we are currently seeking an Manager, CRA Quality Assurance & Training to add to our team!
Your Main Responsibilities and Duties Include:
- Conducting training and quality assessments of CRAs (TI employees and contractors).
- Developing CRA training objectives and establishing individualized training plans for each CRA for onboarding and as needed.
- Assisting with the development and implementation of quality management plans for CRAs.
- Providing CRA feedback to Clinical Operations Management in order to contribute to CRA performance evaluations.
- Participating in employee and contractor hiring as needed.
- Reviewing monitoring reports for quality and training purposes.
- Assisting with the development and implementation of CRA clinical project management related work instructions, processes, and tools under the direction of Sr. Director, Clinical Operations to ensure consistency in the management of clinical studies.
- Developing training curricula to facilitate site monitoring skills development.
- Training, mentoring and evaluating clinical research associates’ performance, including attending monitoring visit(s) with new CRAs to confirm proficiency with TI procedures and standards.
- Working with internal and external training resources, as required, to ensure that all CRAs reach and maintain their training objectives.
- Assisting Clinical Operations Management with developing, executing and documenting monthly CRA Meetings.
- Conducting on-site audits of CRAs to verify compliance with internal and external standards.
- Performing and / or assisting CRAs with clinical study site visits to ensure subject safety and protocol compliance, and to provide site corrective actions as needed.
- Performing and / or assisting CRAs with clinical study site visits to ensure subject safety and protocol compliance, and to provide site corrective actions as needed.
- Assisting Clinical Operations Management as needed.
- Willing to travel 60-80%, as company needs demand.
To Succeed in this Position:
- You will have a Bachelor’s degree and a minimum combination of five (5) years of clinical research field monitoring experience as a Sr. Clinical Research Associate and
- You will at least four (4) years’ experience in a clinical quality assurance role. Additional experience in a training role is highly preferred.
- You should possess a thorough understanding of GCPs, FDA and ICH guidelines.
- You should have excellent written and oral communication skills with the ability to manage multiple priorities.
- High attention to detail is critical for this role.
The most likely starting base pay range for this position is $135,000 - $145,000 per year. Experience will determine an individual’s exact level of compensation. Consideration will be given to experience that exceeds the listed requirements.
We at Therapeutics, Inc. are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Salary : $135,000 - $145,000
