Clinical Research Coordinator - Full Time

 

About the job

 

Who Are We?

Founded in 2003, Therapeutics Clinical Research (TCR) is a leading dermatology research center in San Diego committed to excellence in study conduct and patient care. We conduct Phase I - IV clinical research trials in indications such as skin cancer, psoriasis, acne, hyperhidrosis, rosacea and eczema for pediatric and adult populations. As a company, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics Clinical Research, you are not just a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team, our patients, and our clients.

 

Who Are You?

You are an individual who is passionate about your work and you would love to make a real difference in patient lives. You lead with humility and know that your individual contribution is important to the team 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.

 

As a Clinical Research Coordinator Your Main Responsibilities and Duties Will Include:

• Assisting in preparation, organization and management of clinical essential document files to ensure accuracy and currency of all essential regulatory records

• Maintaining study documents in compliance with all applicable regulations

• Providing protocol specific training to ancillary research site staff, when applicable

• Attending weekly staff meetings and review protocol specific training, when applicable

• Creating, printing and distributing study specific documents for multiple clinical trials

• Creating Source documents and transcribing to case report forms

• Maintaining multidisciplinary project knowledge

• Collaborating with the Regulatory Liaison to ensure all regulatory and IRB documentation is in adherence to FDA Regulations and ICH/GCP Guidelines

• Performing Informed Consent process with subjects and review executed Informed Consent Documents for completeness

• Becoming a subject matter expert on specific clinical and therapeutic knowledge related to studies and related protocols

• Meeting with the Sponsor representatives to discuss the conduct of the study and review study data at various types of visits (site qualification, initiation, interim monitoring visits, etc.)

• Attending Qualification, Initiation, Interim and Closeout monitoring visits

• Scheduling and leading kick-off and launch meetings for assigned studies

• Performing drug accountability and reconciliation. Also, acting as pharmacist when applicable per protocol

• Conducting the clinical study according to FDA regulations and guidelines

• Designing tools that assist in accurately recording study activities and ensuring these activities are in compliance with GCP and study protocols

• Ensuring the safety and welfare of the study participants

• Recruiting and screening potential study participants if needed

• Assisting with reporting serious adverse experiences to the appropriate Institutional Review Boards

• Providing assistance in completing paper and/or electronic case report forms and for the selected studies

• Attending investigator meetings (as required) to learn study requirements, meet sponsor personnel, represent the site and convey all information to the site study team upon return

• Serving as back up to front desk staff, laboratory staff and regulatory when requested

• Assisting fellow coordinators with study-related tasks, as needed

 

To Succeed in this Position:

• You should have at least 1+ years' experience as a Clinical Research Coordinator at a clinical research site, or government or academic research institution.

• You should have excellent written and verbal communication skills, friendly disposition, and ability to form and nurture interpersonal relationships to provide best-in-class patient care.

• You have high-level problem-solving, planning and organization skills

• You should take pride in your work and possess impeccable attention to detail.

• If you have experience with source creation, phlebotomy, and lab processing it is highly preferred.

• You should have the willingness to travel up to 10% to attend Investigator Meetings for assigned studies.

• You should be legally authorized to work in the United States.

 

Due to the nature of our work within a healthcare facility, all employees are required to receive COVID-19 vaccinations as a condition of employment unless a reasonable accommodation is approved.

 

We at Therapeutics Clinical Research 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!