Clinical Trial Associate
Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.
Position Summary:
The Clinical Trial Associate (“CTA”) is a highly skilled specialist contributing to the development of relevant concepts, techniques and processes by assisting and helping lead the study team across all investigator sites. Based on experience, the CTA assumes responsibility for more complex tasks and applies creative and effective solutions where needed. Typically working on assignments requiring judgement and initiatives with an understanding of the implications of the work being performed, the CTA independently identifies tasks/issues that need to be addressed while being highly organized with the ability to multitask and adjust direction based on changing project/corporate priorities. The CTA may act as a Clinical Research Associate with limited monitoring responsibilities.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
Execute study activities according to study protocol, regulatory guidelines and operational plan
Review Investigational Drug Brochure (IDB), protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for a thorough understanding of study drug and procedures
Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards
Participate in study start-up, conduct, and closeout activities
Perform project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines
Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes
Collect and review site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.)
Assemble and distribute regulatory binders to clinical sites
Draft and/or assist with preparation of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)
Support project management activities including taking meeting minutes, providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study-status trackers
Assist with preparation and distribution of investigator site contracts and budgets
Schedule, set up, and minute study team and vendor meetings, as applicable
Maintain metrics on results of study documentation reviews
Support the review of invoices from vendors/consultants as needed
Support the review of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT
Support the planning of Investigator Meetings and/or Site and CRA trainings
Manage the oversight of sample collection (i.e., tissue samples, lab samples, scans, PK samples)
Maintain the Trial Master File for all clinical projects
Perform periodic reviews and QC of the Trial Master File
Travel as required to carry out responsibilities
Other duties as assigned
Education and Experience:
Bachelor’s degree biological sciences or related discipline (an equivalent combination of experience and education may be considered)
Excellent written and verbal communication skills
Strong PC skills (MS Word, MS Excel, MS Project)
Sound analytical and problem-solving skills
Act with consistent sense of urgency with acute attention to detail.
Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred.
Exceptional organizational and time management skills
Physical Demands and Work Environment:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
Travel:
You may be required to travel for up to 5% of your time.
Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Salary Range
The salary range for this position is: $70,000 - $87,000.In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
Apply To This Job
Position Summary:
The Clinical Trial Associate (“CTA”) is a highly skilled specialist contributing to the development of relevant concepts, techniques and processes by assisting and helping lead the study team across all investigator sites. Based on experience, the CTA assumes responsibility for more complex tasks and applies creative and effective solutions where needed. Typically working on assignments requiring judgement and initiatives with an understanding of the implications of the work being performed, the CTA independently identifies tasks/issues that need to be addressed while being highly organized with the ability to multitask and adjust direction based on changing project/corporate priorities. The CTA may act as a Clinical Research Associate with limited monitoring responsibilities.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
Execute study activities according to study protocol, regulatory guidelines and operational plan
Review Investigational Drug Brochure (IDB), protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for a thorough understanding of study drug and procedures
Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards
Participate in study start-up, conduct, and closeout activities
Perform project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines
Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes
Collect and review site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.)
Assemble and distribute regulatory binders to clinical sites
Draft and/or assist with preparation of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)
Support project management activities including taking meeting minutes, providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study-status trackers
Assist with preparation and distribution of investigator site contracts and budgets
Schedule, set up, and minute study team and vendor meetings, as applicable
Maintain metrics on results of study documentation reviews
Support the review of invoices from vendors/consultants as needed
Support the review of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT
Support the planning of Investigator Meetings and/or Site and CRA trainings
Manage the oversight of sample collection (i.e., tissue samples, lab samples, scans, PK samples)
Maintain the Trial Master File for all clinical projects
Perform periodic reviews and QC of the Trial Master File
Travel as required to carry out responsibilities
Other duties as assigned
Education and Experience:
Bachelor’s degree biological sciences or related discipline (an equivalent combination of experience and education may be considered)
Excellent written and verbal communication skills
Strong PC skills (MS Word, MS Excel, MS Project)
Sound analytical and problem-solving skills
Act with consistent sense of urgency with acute attention to detail.
Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred.
Exceptional organizational and time management skills
Physical Demands and Work Environment:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
Travel:
You may be required to travel for up to 5% of your time.
Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Salary Range
The salary range for this position is: $70,000 - $87,000.In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
Apply To This Job