Clinical Research Associate at Jobot
San Diego, CA 92121
About the Job
Huge opportunity to join a leading clinical stage biotech company! Strong benefits + pay!
This Jobot Job is hosted by: Luke Hoyt
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $100,000 - $120,000 per year
A bit about us:
A clinical stage biotech company focused on innovative discovery research and clinical development in oncology. The company received three IND clearances from the FDA recently: PT199 for solid tumors, PT886 for pancreatic, GEJ and gastric cancers, and PT217 for small cell lung cancer (SCLC). In addition, both PT886 and PT217 have received orphan drug and Fast Track designations from the FDA. We are looking for motivated and passionate people to join us to help discover and develop new medicines and improve healthcare. We believe that innovative thinking, seamless execution, teamwork, and integrity are key values for building success. Our mission is to become a major source of innovation in the biotech and pharma industry.
Why join us?
Competitive compensation package including bonus opportunities and stock options opportunities
Exceptional career growth opportunities
Excellent medical, dental and vision plans
Generous vacation and sick leave plans
16 paid company holidays per year plus flexible floating holidays
An opportunity to do truly meaningful work to make a lasting impact
On-site gym, ample parking including complimentary EV charging stations, company-sponsored events, etc.
Flexible spending accounts (FSAs) for eligible out-of-pocket health care and dependent day care expenses
Health savings accounts (HSAs) a trust or custodial account to pay or reimburse certain medical expenses
Life and AD&D insurance, short and long term disability plans
Employee assistance program (EAP) provides employee counseling programs and various online resources
Additional voluntary benefits including pet insurance, auto and home insurance, commuter benefits, legal plans, and more
Job Details
Key Responsibilities:
Conducts pre-study (site qualification), initiation, routine monitoring and closeout visits and ensures these visits are completed according to the Clinical Monitoring Plan(s) and SOPs.
Trains the study investigators and staff during the SIV and to trial-specific updates, all to industry standards
Prepares site visit reports and sends confirmation/follow-up letters to sites per the Clinical Monitoring Plan(s)
Conducts and documents periodic telephone contact with sites in accordance with the Monitoring Plan
Verifies data entered into the case report forms (CRFs) is consistent with subject clinical records, electronic medical records and source data to ensure accuracy
Ensures data collection timelines and deliverables are met at assigned clinical sites in accordance with study plans
Works with Data Management to ensure the query resolution process is followed and completed
Identifies and reports protocol deviations in accordance with the Protocol Deviation Plans and monitors site submission to the IRB/EC per reporting policies
Ensures site compliance to SAE reporting policy per protocol and with the Safety Management Plans
Ensures site adherence to study protocols and compliance with ICH/GCP/local regulations at assigned clinical sites. Immediately reports non-compliance to the CTM and/or head of clinical operations
Assists the CTM and/or head of clinical operations in the development and implementation of corrected actions for the addressing non-compliance issues at individual sites and across study, including timely follow-up to routine and for-cause Quality Assurance audits
Work with investigators on their subject recruitment and screening strategies
Tracks and reports progress of assigned sites, including study start up, subject screening/enrollment, data collection, adverse event documentation and Frequently Asked Questions document updates
Partners with the in-house CTAs and/or CRAs in the collection, review, and tracking of essential documents to ensure completeness of both site files and eTMF
Upload documents into the eTMF and completes coding and QCs as required
Assists with planning, preparing, distributing and presenting materials for Investigator Meetings and for study-related trainings
Provides ongoing study-related training (i.e., EDC) and support to site staff as necessary
Works with Clinical Team in the management of Investigational Product (IP) at clinical sites
Manages inventory of clinical supplies at assigned sites and monitors the documentation of returns/destruction as appropriate
May collaborate with the head of clinical operations and/or in-house CTM/CTA/CRAs on the development of certain study-specific plans and/or processes
Ensure proper collection, storage and shipment of laboratory specimens
Participates in Clinical Trial Team Meetings
Other duties as assigned by the Head of Clinical Operations.
Qualifications:
Bachelor’s Degree (BA/BS) in life sciences or nursing degree
Minimum of five (5) or more years of relevant experience in clinical research or healthcare related industry, including a minimum of 2 years direct field monitoring experience, or equivalent combination of education and experience
Independent site monitoring experience in all phases of clinical trials (phase 1, 2, and 3)
Experience in oncology is highly preferred
Experience/training in the following areas: GCP Regulations, ICH Guidelines, Good Quality Practices, 21CFR, HIPAA, Drug Development and Approval Process
Proficiency with MS Office
Excellent oral and written communication skills including presentation skills
Ability and willingness to travel to investigational sites for on-site monitoring visits, up to 70% of the time.
Ability to perform virtual monitoring remotely as needed
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
This Jobot Job is hosted by: Luke Hoyt
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $100,000 - $120,000 per year
A bit about us:
A clinical stage biotech company focused on innovative discovery research and clinical development in oncology. The company received three IND clearances from the FDA recently: PT199 for solid tumors, PT886 for pancreatic, GEJ and gastric cancers, and PT217 for small cell lung cancer (SCLC). In addition, both PT886 and PT217 have received orphan drug and Fast Track designations from the FDA. We are looking for motivated and passionate people to join us to help discover and develop new medicines and improve healthcare. We believe that innovative thinking, seamless execution, teamwork, and integrity are key values for building success. Our mission is to become a major source of innovation in the biotech and pharma industry.
Why join us?
Competitive compensation package including bonus opportunities and stock options opportunities
Exceptional career growth opportunities
Excellent medical, dental and vision plans
Generous vacation and sick leave plans
16 paid company holidays per year plus flexible floating holidays
An opportunity to do truly meaningful work to make a lasting impact
On-site gym, ample parking including complimentary EV charging stations, company-sponsored events, etc.
Flexible spending accounts (FSAs) for eligible out-of-pocket health care and dependent day care expenses
Health savings accounts (HSAs) a trust or custodial account to pay or reimburse certain medical expenses
Life and AD&D insurance, short and long term disability plans
Employee assistance program (EAP) provides employee counseling programs and various online resources
Additional voluntary benefits including pet insurance, auto and home insurance, commuter benefits, legal plans, and more
Job Details
Key Responsibilities:
Conducts pre-study (site qualification), initiation, routine monitoring and closeout visits and ensures these visits are completed according to the Clinical Monitoring Plan(s) and SOPs.
Trains the study investigators and staff during the SIV and to trial-specific updates, all to industry standards
Prepares site visit reports and sends confirmation/follow-up letters to sites per the Clinical Monitoring Plan(s)
Conducts and documents periodic telephone contact with sites in accordance with the Monitoring Plan
Verifies data entered into the case report forms (CRFs) is consistent with subject clinical records, electronic medical records and source data to ensure accuracy
Ensures data collection timelines and deliverables are met at assigned clinical sites in accordance with study plans
Works with Data Management to ensure the query resolution process is followed and completed
Identifies and reports protocol deviations in accordance with the Protocol Deviation Plans and monitors site submission to the IRB/EC per reporting policies
Ensures site compliance to SAE reporting policy per protocol and with the Safety Management Plans
Ensures site adherence to study protocols and compliance with ICH/GCP/local regulations at assigned clinical sites. Immediately reports non-compliance to the CTM and/or head of clinical operations
Assists the CTM and/or head of clinical operations in the development and implementation of corrected actions for the addressing non-compliance issues at individual sites and across study, including timely follow-up to routine and for-cause Quality Assurance audits
Work with investigators on their subject recruitment and screening strategies
Tracks and reports progress of assigned sites, including study start up, subject screening/enrollment, data collection, adverse event documentation and Frequently Asked Questions document updates
Partners with the in-house CTAs and/or CRAs in the collection, review, and tracking of essential documents to ensure completeness of both site files and eTMF
Upload documents into the eTMF and completes coding and QCs as required
Assists with planning, preparing, distributing and presenting materials for Investigator Meetings and for study-related trainings
Provides ongoing study-related training (i.e., EDC) and support to site staff as necessary
Works with Clinical Team in the management of Investigational Product (IP) at clinical sites
Manages inventory of clinical supplies at assigned sites and monitors the documentation of returns/destruction as appropriate
May collaborate with the head of clinical operations and/or in-house CTM/CTA/CRAs on the development of certain study-specific plans and/or processes
Ensure proper collection, storage and shipment of laboratory specimens
Participates in Clinical Trial Team Meetings
Other duties as assigned by the Head of Clinical Operations.
Qualifications:
Bachelor’s Degree (BA/BS) in life sciences or nursing degree
Minimum of five (5) or more years of relevant experience in clinical research or healthcare related industry, including a minimum of 2 years direct field monitoring experience, or equivalent combination of education and experience
Independent site monitoring experience in all phases of clinical trials (phase 1, 2, and 3)
Experience in oncology is highly preferred
Experience/training in the following areas: GCP Regulations, ICH Guidelines, Good Quality Practices, 21CFR, HIPAA, Drug Development and Approval Process
Proficiency with MS Office
Excellent oral and written communication skills including presentation skills
Ability and willingness to travel to investigational sites for on-site monitoring visits, up to 70% of the time.
Ability to perform virtual monitoring remotely as needed
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
Salary
100,000 - 120,000 /year