Job Description

Job Description

Job Description

Salary:

Who Are We?

Founded in 1997 and built upon 25+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diegos 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.

What is the Primary Objective of the Sr. Clinical Research Associate (Sr. CRA)?

You will manage clinical study sites to ensure subject safety and compliance with the study protocol, timeline and budget, in support of on time and within budget regulatory submissions.

Your Main Responsibilities and Duties Include:

• You will assess of the suitability of clinical sites to conduct specific studies.
• You will initiate selected clinical study sites by providing training related to the protocol and management of the study.
• You will perform routine monitoring of clinical study sites to ensure subject safety and protocol compliance.
• You are responsible for the verification of data entered on the CRFs is consistent with clinical notes and other source documents.
• You will collect completed CRFs and queries from clinical sites.
• You will write monitoring visit reports and ensure the accountability of all test articles.
• You will close-out of clinical sites upon completion of the study.
• You will assist with study file audits and site audit preparation.
• You will develop and maintain routine contact with clinical study investigators and staff.
• You will assist with protocol, case report form and source document template development.
• You will ensure compliance with appropriate regulatory (GCP, FDA, ICH, HBP, etc.) and internal guidelines.
• You will assist with final report preparation.
• You will assist with internal SOP/guideline development.
• You will coordinate supplies forecasting and distribution and communicate across departments and conduct project team meetings concerning status of the study and specific sites.
• You will assist in the occasional mentoring and training of more junior level Clinical Research Associates on monitoring procedures and TI SOPs.

To Succeed in this Position:

• You will be based close to major metropolitan area and airport hub.
• Ideally, you will have a Bachelors degree in a scientific discipline, RN or BSN degree, 4-year Life Science degree or equivalent and at least 3-5 years experience in clinical trial monitoring.
• You must possess a knowledge/understanding of the principles of clinical research and drug development.
• You must have excellent written and oral communication skills, with the ability to manage multiple priorities.
• You must be able to follow directions. Attention to detail is critical for this role.
• You must be able to work efficiently to meet timelines.
• You must be comfortable using the Microsoft Office Suite, Zoom/GoToMeeting/Teams, or other similar technology.
• You must be willing to travel 60-80%
  
• You should have at least 85% availability, but we would prefer 100% availability for this contract position.

THIS IS A CONTRACT POSITION

Therapeutics, Inc. reasonably anticipates the pay for this contract to be between $70/hr. to $100/hr. DOE.

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. If you are smart and good at what you do, we welcome you to apply!

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