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quality assurance specialist

STARS Behavioral Health Group

<div><h1 class="jobSectionHeader"><b>Partner with us in making a positive change!</b></h1><p></p><p>
Join a team where your work truly matters. We're proud to have been certified as a Great Place to Work for 8 years by our own employees. We invite you to partner with us in our mission to improve mental healthcare.</p><p></p><p><b>
Job Title:</b></p>
Quality Assurance Specialist<p><b>
Division/Program:</b></p>
Los Angeles Crisis Residential Treatment (CS)<p><b>
Starting Compensation:</b></p>
23.00 - 24.00<p><b>
Working Location:</b></p>
Los Angeles CA 90033<p><b>
Working Hours/Shift:</b></p>
Mon - Fri 9 am to 5:30 pm<p></p><p><b>
Why Join Our Team?</b></p><ul><li><p><b>
Competitive Compensation</b>: Offering a salary that matches your skills and experience.</p></li><li><p><b>
Generous Time Off</b>: Enjoy ample vacation and holiday pay.</p></li><li><p><b>
Comprehensive Benefits Package</b>:</p></li><li><ul><li><p>
Employer-paid medical, dental, and vision coverage.</p></li><li><p>
Additional voluntary benefits to support your lifestyle.</p></li></ul></li><li><p><b>
Professional Growth Opportunities</b>:</p></li><li><ul><li><p>
On-the-job training with access to paid CEU opportunities.</p></li><li><p>
Career development programs designed to help you grow.</p></li><li><p>
Supervision for BBS hours for AMFT, ACSW, and APCC professionals (where applicable).</p></li></ul></li></ul><p><b>
Employee Recognition &amp; Rewards</b>: A culture that celebrates and rewards your hard work and dedication</p><p><b>
What you bring to SBHG</b><b> </b>(qualifications)<b>:</b></p><ul><li><p>
Bachelor&rsquo;s degree in Quality Improvement/Quality Assurance, human services, psychology, or related social science field, or LVN license.</p></li><li><p>
Two (2) years of experience in the mental health field or a QA position required, preferably in in-patient setting.</p></li><li><p>
Two (2) years of experience in QA/TQM preferred.</p></li><li><p>
One (1) year experience in LACDMH clinical documentation preferred.</p></li><li><p>
Must possess a valid CA driver's license and maintain a driving record that meets the company driver eligibility policy.</p></li></ul><p></p><div><p><b><br>
How you will make a difference</b>:</p></div><div><p>
The Quality Assurance Specialist is responsible for the aiding the QA Manager in the execution of the quality assurance program policies and procedures for the Crisis Residential Treatment facilities. The position is responsible for auditing documentation to reconcile with billing and oversees documentation of services by staff to assure conformity with Medi-Cal, Los Angeles County DMH, other outside agencies, and internal standards and policies. The Quality Assurance Specialist manages all charts with deficiencies by processing them to the appropriate department for correction. The position is also responsible for ensuring the discharged chart is closed in the correct order and completed. Position aids the QA Manager in the oversight of the Continuous Quality Assurance program, medical records and records all CQI data. Assists in the coordination and development of CQI presentations and information gathering to execute presentations as needed. Activities performed can be time sensitive with expectations of frequent reporting of progress along with thorough oversight for accuracy. Regular interaction with all staff members, physicians, and outside agencies is expected. This position has responsibility for gathering and analyzing agency data and assisting in the agency&rsquo;s quality control, quality assurance, and quality improvement efforts. In addition, the Quality Assurance Specialist&rsquo;s duties will include but are not limited to ensuring that the chart documentation is maintained, data collection into the L.A. County data collection sites is maintained and other quality improvement tasks as assigned.</p><p></p><div><p><b>
Division/Program Overview:</b></p></div><div><ul><li><p>
16-bed facilities</p></li><li><p>
Designed for adults with mental health challenges or a recent crisis who need intensive treatment.</p></li><li><p>
24/7 programs as an alternative to urgent care or hospitalization.</p></li><li><p>
Individuals can live on-site in a homelike setting for a short term while they receive counseling and learn basic living and interpersonal skills.</p></li><li><p>
Able to receive physical and psychological evaluation, mental health, and case management services, in addition to assistance locating permanent housing.</p></li></ul></div></div><p></p><p><b>
Learn more about SBHG at</b>: https://www.starsinc.com/stars-inc/</p><p><b>
For Additional Information:</b></p><p></p>
Stgarcia@starsinc.com</div><p></p>

Quality Assurance Specialist

Pharmalogic Holdings

<div></div><div><div><div><div><div><div>PharmaLogic is the fastest-growing SPECT &amp; PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside.</div><div><div><br>
PharmaLogic offers you an exceptional opportunity to join our dynamic team as an On-Site Quality Assurance Specialist!</div></div><p></p><div><div><div><div><p><b><br>
Hours - </b><b>2am to 4pm, in rotating 8-hour shifts</b></p><p><b>
Role Summary:</b></p><p></p><p><br>
As the Quality Assurance Specialist, you will play a vital role in the PharmaLogic quality program to assure compliance with cGMP and other standards for the manufacture of PET drugs for administration to patients. Responsible for completion of required quality assurance tasks of finished drug product as directed by cGMP SOPs and serves as site expert on PET quality assurance. The position involves a hands-on role in all PET quality assurance duties for the site, including materials acceptance and quarantine, batch release &amp; record review, PET drug quality control, sterility, environmental monitoring, equipment maintenance / qualification/ calibration, investigation (IR,OOS, deviation, etc.) and corrective actions (CAPA), SOP writing, maintenance and review, inspection readiness, data quality and integrity, ANDA documentation and other routine QA functions. The QA Specialist is the responsible person for FDA inspections at the site and is listed on the FDA filing and associated permits as applicable.</p><p></p><p><br>
Ideally, there will be separation of QA functions from production and QC functions. However, depending on the size of the facility, these activities may be performed by the same person if there is the ability to segregate batch release from production through appropriate cross-training for batch release. For smaller facilities, the site QA may assume other duties which may include production activities, operation of the facility's cyclotron and associated chemistry modules and analytical equipment for production and QC of PET radiopharmaceuticals. The position may be required to perform various radiation safety and quality related tasks as directed by management.</p><p></p><p><b><br>
Job Responsibilities and Duties:</b></p><ul><li> Ensure compliance with all regulatory commitments and company policies and SOPs including cGMP and radiation safety.</li><li> Actively promote adherence to SOPs, as well as safety rules and awareness. Report and take initiative to correct safety &amp; environmental hazards.</li><li> Provide immediate notification of quality related issues to site Manager, PET Operations Management and Q&amp;R as necessary.</li><li> Oversee production operations to assure that PET drugs meet requirements for identity, strength, quality and purity.</li><li> May Perform PET radiopharmaceutical Quality Control (QC) in cGMP environment; May perform aseptic processing related tasks.</li><li> Responsible for quality assurance oversight of routine production, packaging and shipping of radioisotopes.</li><li> Examine and approve/reject components, closures, in-process materials, packaging materials, labeling and finished dosage forms to assure that all meet specification; manage onsite inventory quarantine and control process according to SOPs to assure specifications are met. Assure approved vendors used and maintain documents and records, including COA.</li><li> Review batch, laboratory and production records to assure completeness, accuracy and conformance before batch release; authorize or reject batch according to SOPs or oversee batch release by other qualified team members. Perform batch trending analysis.</li><li> Notify facility manager if any recall necessary to assure that recalled materials are not administered to patients. Complaint handling SOP followed.</li><li> Initiate change to SOPs, participate in authoring and review of SOPs, maintain documents under control in QMS. Assure SOPs match processes and procedures in PET manufacturing operation and report concerns to Management.</li><li> Document and Trend deviations, IRs, events and. Initiate investigation and assure documentation of corrective actions and retraining as applicable. Initiate and complete CAPA investigation as deemed necessary and report results and trends.</li><li> Maintain facility compliance with environmental monitoring and aseptic control; Review and trend environmental monitoring results and all testing records.</li><li> Provide training to staff on QA activities and SOPs. Assure staff is qualified for assigned quality tasks with documentation of training and qualification. Maintain records for inspection. Perform annual retraining upkeep of training files.</li><li> Assure aseptic processing of samples and products, as per SOP. Assure aseptic processing area suitably cleaned, maintained, controlled to prevent mix-ups or contamination; assure personnel qualified in aseptic technique and cleaning of the area and that approved cleaning agents and processes used according to SOP. Assure environmental monitoring records are complete and readily available, including annual personnel media fill qualifications.</li><li> Assure equipment is functional, within calibration, suitable for use, maintained and documented per SOP. Assure equipment qualified and operated under specified conditions; maintain vendor IQ/OQ and site PQ documents.</li><li> Assure master production, laboratory controls/analytical tests and other control records are consistent with actual work procedures and any discrepancies reported to PharmaLogic Quality and Regulatory.</li><li> Maintain records to comply with FDA and SOP requirements. Maintain, monitor, and report out on the location QA program to management.</li><li> Site lead for FDA and other agency, vendor and internal quality audits, as directed. Maintain site audit readiness by thorough records, personnel, and facility review.</li><li> Maintain site copy of ANDA and all related filing documentation up to date, available and organized for review. Draft ANDA related documents for submission including annual reports and other updates as required.</li><li> Conduct periodic and annual quality audits, training, SOP review and other activities as directed.</li><li> Other duties, if training and qualification are documented; related duties as assigned.</li></ul><p></p><p><b><br>
Job Requirements Skills Education:</b></p><ul><li> BS/BA degree in a relevant scientific discipline (chemistry, physics, nuclear pharmacy, nuclear medicine, engineering, etc.) and a minimum of 3-5 years Quality experience in the pharmaceutical industry, or an equivalent combination of education and experience preferred. Pharmacy tech certification a plus; experience with aseptic technique preferred.</li><li> Experience working with ionizing radiation and laboratory equipment desirable including troubleshooting and repairs.</li><li> Strong analytical, critical thinking and customer service skills. Experience working on a cross-functional team in fast-paced environment.</li><li> Strong knowledge of cGMP environment and regulations. Knowledge of CFR21 Part 212 preferred.</li><li> Strong attention to detail and experience with managing multiple projects and priorities.</li></ul><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div>
PharmaLogic is an Equal Opportunity Employer.</div></div><div></div><div><div><br>
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.</div><div></div><div><div><br>
Benefits Include:</div></div><div></div><div><ul><li><div><br>
401(k) retirement benefit program</div></li><li><div>
Medical</div></li><li><div>
Dental care</div></li><li><div>
Disability insurance</div></li><li><div>
Employee assistance program</div></li><li><div>
Extended health care</div></li><li><div>
Life insurance</div></li><li><div>
On-site parking</div></li><li><div>
Paid time off</div></li><li><div>
Vision care</div></li></ul></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div><br>
<div></div>
The hours for this position are 10:00 pm to 6:00 am.<br>
40 Hours/Week</div></div></div></div></div></div></div></div></div></div><br>
Hours - 2am to 4pm, in rotating 8-hour shifts<br>
40 HOURS/WEEK</div>

MANTECH

<div><p>MANTECH is seeking a motivated, career and customer-oriented <b>Information Technology Assurance Specialist I </b>to join our team in <b>El Segundo, CA</b>.</p><p></p><p>
The Information Technology Assurance Specialist's primary function is to work within Special Access Programs (SAPs) supporting SSC and AFSPC Operational Units. The position will provide &ldquo;day-to-day&rdquo; support for Collateral, Sensitive Compartmented Information (SCI) and Special Access Program (SAP) activities.</p><p></p><p><b>
Responsibilities include but are not limited to:</b></p><ul><li><p>
Establish complex operational software configuration controls and system interfaces for computer system(s) assigned.</p></li><li><p>
Maintain file servers, Firewalls, network access, Security Monitoring Systems and system documentation as required.</p></li><li><p>
Analyze and troubleshoot system anomalies to ensure optimum equipment performance.</p></li><li><p>
Prepare system for operational use and support operational tests.</p></li><li><p>
Review, prepare, and update AIS accreditation packages, notify customer when changes occur that might affect AIS accreditation/certification, perform AIS self-inspections, identify AIS vulnerabilities and implement countermeasures, and ensure AIS and network nodes are operated, maintained, and disposed of in accordance with security policies and practices.</p></li><li><p>
Provide security coordination and review of all system test plans, guest networks Client Support, Help Desk &amp; troubleshooting, and Personal-Issue Laptop Support.</p></li><li><p>
Perform VTC System Administration, Scheduling, &amp; Configuration, Account Creations, changes, &amp; deletions, Hardware/Software System Configuration, upgrades and modifications, Media Control &amp; Accountability, and COMSEC account/equipment management.</p></li></ul><p></p><p><b>
Minimum Qualifications:</b></p><ul><li><p>
Bachelor&rsquo;s degree in a related field or 4 additional years of equivalent experience will be considered in lieu of degree.</p></li><li><p>
2+ years of total experience working with Information Technology Assurance.</p></li><li><p>
2+ years of experience working in a SCI environment.</p></li><li><p>
Must have CompTIA Sec + certificate as outlined in DoD Directive 8570.01-M for Information Assurance Technician Level 2 within 6 months of the date of hire.</p></li><li><p>
Must complete training on Joint Security Implementation Guidance (JSIG) and Risk Management Framework (RMF) Information Security Continuous Monitoring (ISCM) (if supported organization requires development of AIS accreditation packages).</p></li></ul><p></p><p><b>
Preferred Qualifications:</b></p><ul><li><p>
1+ years of SAP related experience highly desired.</p></li><li><p>
Working knowledge of Local Area Network (LAN) and Wide Area Network (WAN) technologies and data backup technologies to include communication security (COMSEC) integration.</p></li><li><p>
Working knowledge of JAFAN 6/0, DCID/JAFAN 6/3, DCID/JAFAN 6/9, and Joint DODIIS/Cryptologic SCI Information Systems Security Standards, Common Criteria, and System Security Policy as they relate to C&amp;A for Legacy systems.</p></li><li><p>
Working knowledge and current relevant experience with PL1 &amp; PL2 systems; experience with PL3 &amp; PL4 cross domain solutions desired.</p></li><li><p>
Must have the ability to work in a dynamic environment and effectively interact with numerous DOD, military/civilian personnel and industry partners.</p></li><li><p>
Working knowledge of Microsoft Office (Word, PowerPoint, and Excel).</p></li></ul><p></p><p><b>
Clearance Requirements:</b></p><ul><li><p>
Current Top-Secret Clearance with SCI Eligibility.</p></li><li><p>
Eligibility for access to Special Access Program Information.</p></li><li><p>
Willingness to submit to a polygraph.</p></li></ul><p></p><p><b>
Physical Requirements:
</b></p><ul><li><p>Must be able to remain in a stationary position 50%.</p></li><li><p>
Needs to occasionally move about inside the office to access file cabinets, office machinery, etc.</p></li><li><p>
Constantly operates a computer and other office productivity machinery, such as a calculator, machine and computer printer.</p></li><li><p>
Frequently communicates with co-workers, management and customers, which may involve delivering presentations. Must be able to exchange accurate information in these situations.</p></li></ul></div>

Information Technology Assurance Specialist

Clinica Romero

<div><p><b>Position Title: </b>Substance Use Disorder Case Manager / Outreach Specialist<br>
<b>Department: </b>Substance Use Disorder<br>
<b>Reports To:</b><br>
Substance Use Disorder Program Director<br>
<b>Status: </b>Full-Time, Union</p><br>
<p></p>
<p><b>
Position Summary:</b><br>
Clinica Romero&rsquo;s Substance Use Disorder Case Manager will provide Case Management to Court/DCFS/Probation/Self-Referred clients. Will assist clients in meeting program goals and objectives, document all progress and facilitate group sessions as needed. Assist with the outreach efforts and promote Drug and Alcohol Department Services to the community.</p><br>
<p></p>
<p><b>
Responsibilities:</b></p>
<ul>
<li>Provide assessments, interventions, individual sessions, treatment plans, urine analysis screenings, intakes, case management, crisis intervention, level of care changes, justifications, and discharge summaries.<br>
</li>
Ensure all patient charts meet county and state requirements; meet timelines and document all services provided within 48 hours of service date.<br>
<li>
<br>
</li><li><br>
Responsible for recruitment of new clients in both the youth and adult population</li><br>
<li><br>
Responsibilities may include field-based outreach activities, including engagement with unhoused individuals and participation in external community outreach events, as assigned to designated positions based on program service needs.</li>
<li>Case Manage/Counsel both youths and adults that have substance abuse problems</li><br>
<li><br>
Responsible for a substantial case load and providing their clients with quality service<br>
</li>
<li>Transport clients to and from program if needed<br>
</li>
<li>Attend meetings, community events and outreach to insure we are meeting capacity for specialty services<br>
</li>
<li>Responsible for completing a minimum of 20 billable hours per week, which excludes group sessions.
<br>
</li><li>Submits billable hours and calendar on a weekly basis to Program Director/Quality Assurance Counselor to ensure billable outcomes are being met.
</li><li>Other assigned duties.</li></ul><br>
<p></p>
<p><b>
Qualifications</b></p>
<ul>
<li>Must be registered through CCAPP, CAADE, or qualifying certified body<br>
</li>
<li>A minimum of one year&rsquo; experience working in the field of addiction.<br>
</li>
<li>Must have completed formal education in SUD.<br>
</li>
<li>Must be highly motivated and demonstrate good communication skills
<br>
</li>Must be able to deliver strong, high-energy outreach to the community.<br>
<li>
<br>
</li><li><br>
Must have the ability to recruit new clients (adults and youth) to our agency.</li>
</ul><ul><li>Must understand the 12 Core Functions.<br>
</li>
<li>Must have the ability to write individual and group progress notes/treatment plans that meet county standard.<br>
</li>
<li>Must have experience in-group facilitation.<br>
</li>
<li>Must demonstrate an understanding of the recovery process, which includes the twelve-step program(s).
<br>
</li><li>Must have experience in observing drug testing of clients.<br>
</li>
<li>Spanish bilingual is plus<br>
</li>
<li>Proficient in Microsoft Office<br>
</li>
<li>Experience working with Drug Medi-Cal clients (Adult and Youth) a plus.<br>
</li>
<li>Understanding of Drug Medi-Cal requirements/process a plus.</li></ul></div>

SUD Case Manager / Outreach Specialist

JWCH Institute

<div><p><b>Position Purpose:</b></p><p>
The Behavioral Health Quality Assurance Manager is responsible for quality assurance and training for all Department of Mental Health programs. The position upholds the JWCH mission to improve the health status and wellbeing of under-served segments of the population of Los Angeles County through the direct provision or coordination of health care, health education, services, and research. This includes interviewing, treating, coordinating, planning, and linkage to a full-range of resources that meet practical, social, and emotional needs, in collaboration with a multidisciplinary team and community-based programs. As a result, patient outcomes and satisfaction are improved, along with organizational fiscal capacity.</p><p><b>
Principal Responsibilities:</b></p><ul><li>
Increase productivity through quality assurance measures</li><li>
Clear understanding of Department of Mental Health programs</li><li>
Providing oversight and supervision for identified staff</li><li>
Develop &amp; maintain training manual and procedures for new hires and current staff</li><li>
Develop and maintain Policies &amp; Procedures (P&amp;Ps) that are aligned with DMH standards</li><li>
Attend and represent the agency at outside meetings to keep aware of new bulletins and distributing information to Leads/Programs</li><li>
Assist in internal compliance meetings</li><li>
Understand Electronic Health Recording (EHR) system, Welligent and Nextgen</li><li>
Provide and/or arrange ongoing Professional Development for clinicians and other providers</li><li>
Provide continuous improvement on systems for screening, referral, enrollment using LEAN/PDSA process.</li><li>
Design and maintain training and QA program for staff which includes monthly peer reviews and DMH QA plan yearly</li><li>
Review and analyze electronic health recording reports to ensure compliance</li><li>
Create materials need for program documentation including but not limited to worksheets, chart checklists, manuals, and monthly newsletters.</li><li>
Oversee all charting required by DMH, including assessments, progress notes, care plans, and billing documentation.</li><li>
Adhere to all organizational safety policies, procedures, and regulatory requirements to ensure a safe environment for patients, staff, and visitors.</li><li>
Participate in required safety and compliance trainings and apply learned practices in daily work activities.</li><li>
Identify, report, and help mitigate unsafe conditions, incidents, or hazards in the workplace.</li><li>
Use equipment, tools, and supplies safely and responsibly in accordance with organizational and regulatory standards.</li><li>
Maintain awareness of infection control, occupational health, and emergency preparedness procedures appropriate to the role.</li><li>
Complete data collection forms and prepare reports as required by the program.</li><li>
Other duties as assigned</li></ul><p><b>
Requirements:</b></p><ul><li>
Master&rsquo;s degree in social work, social welfare, psychology, marriage, family and child counseling, and or marriage and family therapy from an accredited college or university.</li><li>
MFT / LCSW with current California BBS license for 2 years</li><li>
Administrative experience with coordinating care across multiple programs, for 2 or more years</li><li>
Experience with Electronic Health Recording</li><li>
Experience overseeing Department of Mental Health contracts for 2 or more years.</li><li>
Experience supervising clinical staff and interns for 2 or more years</li><li>
Experience with quality assurance and contract compliance for 2 or more years</li><li>
Experience working with low income and/or homeless individuals</li><li>
Demonstrated understanding of the impact of trauma and substance abuse on behavioral and medical conditions</li><li>
Knowledgeable of evidence-based treatments (DBT, CBT, Seeking Safety, Motivational Interviewing)</li><li>
Bilingual (English/Spanish) ability preferred.</li><li><b>All JWCH, Wesley Health Centers workforce members are recommended to be fully vaccinated against COVID-19.</b></li></ul><p>
Become part of a team where your work matters. Apply today and help us change lives, one patient at a time.</p><p><b>
JWCH Institute, Inc + Wesley Health Centers is an Equal Opportunity and Fair Chance Employer.</b></p></div>

Behavioral Health Quality Manager

University of Southern California

<div><p>The University of Southern California (USC), founded in 1880, is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research university and a member of the &quot;Trojan Family,&quot; which is comprised of the faculty, students and staff that make the university what it is.</p><p></p><p><b>
JOB ACCOUNTABILITIES:</b></p><ul><li><p>
Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms, and other study and clinical research documentation to support principal investigators and quality assurance systems for the Clinical Investigations Support Office. Submits protocols and supportingdocuments to internal and external regulatory bodies (i.e. Institutional Review Board), ensuring trials are consistent with approved proposals to open new studies.</p></li><li><p>
Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for CISO functions and research project goals. Manages and maintains CISO electronic regulatory files, including staff resumes, licenses, training certificates, equipment receipts, investigation logs, etc. Reviews documentation as needed to support regulatory filings, and maintains research files and documentation required by regulations.</p></li><li><p>
Works with senior team members to support and facilitate clinical research. Helps prepare and conduct high-quality compliance reviews, including close-out and reporting. Interacting with research investigators and staff throughout the process, from helping activate study and research trials to escalating problems and issues, as needed. Provides support and clinical-specific training to staff, maintaining and improving quality assurance training and development programs as needed.</p></li><li><p>
Updates all databases, and regulatory binders with information pertinent to studying milestone progress, including but not limited to: clinical trial management systems, IRB databases, internal and external spreadsheets, and study electronic systems.</p></li><li><p>
Ensures compliance with all applicable local, state, and federal regulations, statutes, and laws, and with agencies including the IRB and Federal Drug Administration (FDA). Maintains compliance with Good Clinical Practice (GCP) guidelines, patient confidentiality (HIPAA) and any other applicable laws.</p></li><li><p>
Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies (i.e. IRB), pharmaceutical companies (including monitors), principal investigators and colleagues. Works with clinical trial coordinators, research staff and investigators to further communications, helping remove obstacles impeding trial progress.</p></li><li><p>
Participates in KSOM centralized activities to support and promote research regulatory requirements. Coordinates with and assists other CISO staff and departments with educational efforts, helping ensure highest quality research and protection of human subjects. Identifies compliance training and educational needs, coordinates the reporting of serious adverse events and protocol deviations, and proposes, completes, and submits amendments to protocols and trial forms and documentation, as needed.</p></li><li><p>
Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.</p></li></ul><p></p><p><b>
Position location:</b> On-site</p><p></p><p><b>
Salary range:</b></p><p>
The annual rate for this position is $75,968.95 - $101,364.43. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.</p><p></p><p>
USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying.</p><br>
<p></p>
Minimum Education: Bachelor's degree Minimum Experience: 2 years/Combined education/experience as substitute for minimum experience Minimum Field of Expertise: Experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Experience with submissions to the Institutional Review Board and/or the Federal Drug Administration for Investigational Drugs and Devices (IND/IDE). Knowledgeable of Informational Conference on Harmonization-Good Clinical Practice (ICHGCP), Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP) and FDA regulations and procedures. Ability to evaluate the risks and benefits of different solutions, and proven problem-solving and decision-making skills to uncover causes of problems. Exemplary organization skills and attention to detail. Proven ability to interpret, analyze, and apply pertinent policies, procedures, regulations, and requirements. Deft interpersonal and diplomatic skills for communicating tactfully with all levels of staff and diverse individuals and groups. Demonstrated experience developing communication plans, instructional materials and related content. Experience with office management communication software/tools (e.g. Google suite, Slack, Skype). Preferred Education: Bachelor's degree Preferred Experience: Three years Supervises: No Preferred Field of Expertise: Three years&rsquo; experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials. Advanced knowledge of regulations governing human research. Special Instructions to Applicants: Applicant Attachments (Required): R&eacute;sum&eacute; &amp; Cover Letter Applicant Questions: N/A Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms, and other study and clinical research documentation to support principal investigators and quality assurance systems for the Clinical Investigations Support Office. Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for CISO functions and research project goals. Helps prepare and conduct high-quality compliance reviews, including close-out and reporting. Updates all databases, and regulatory binders with information pertinent to studying milestone progress. Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies, pharmaceutical companies, principal investigators and colleagues.</div>

Clinical Research Regulatory Specialist

Cordoba Corporation

<div><div>Cordoba Corporation is a leading engineering and design firm based in California. We are seeking an Assistant Aviation Project Manager to join our Facilities Sector. The Assistant Project Manager is responsible for assisting the Project Manager with managing the scope, cost, schedule and operational interfaces of all design and construction related activities for the client's Replacement Fire Station 51 project. The Assistant Project Manager will be focusedon schedule certainty, budget delivery and making sure that design and construction work meets the required quality standards while enforcing a strong health, safety, and environmental culture on the project. The Assistant Project Manager will assist the project team with the development and implementation of design, construction, testing, commissioning, turnover plans, impacts to the operations, and support the team&rsquo;s risk management and mitigation activities.</div><br>
<ul><li>
Primary liaison and airport/owner representative responsible for directing and managing the project</li><li>
Responsible for scope development and scope management of the project to meet project goals and objectives</li><li>
Develop the GMP and oversee the trade procurement process</li><li>
Providing direction and management for assigned project and ensuring on-schedule completion within or below budget in accordance with contractual obligations</li><li>
Planning and defining program goals and devising methods to accomplish them, developing in-depth knowledge of owner objectives, contract terms, and airport policies</li><li>
Planning, directing, supervising and controlling the execution of all technical, fiscal, and administrative functions of the assigned project</li><li>
Working with team members and airport management to develop budgets, schedules, and plan for the various elements of a project</li><li>
Oversees owner&rsquo;s staff that manages full project delivery including stakeholder interfaces</li><li>
Managing project scope to meet or exceed project goals and objectives</li><li>
Abilities to identify and study options to complex design, operational or constructability issues</li><li>
Ability to conduct field surveys and investigations to capture detailed and accurate field conditions. This information shall be used to enable strategic design and construction decisions</li><li>
Overseeing the Design Manager who will be managing the design process during design and construction including resolution of technical design issues, issuing design non-compliances, issuing field non-conformances, timely processing of RFI&rsquo;s, coordinating shop drawing reviews, participation in and approval of factory and site acceptance tests, coordinating material approvals, coordinating mock up approvals, providing reports, drawings and specification interpretation, participation in testing and commissioning activities, managing the punch list process and other activities as required to ensure the design process supports the project goals</li><li>
Overseeing the Design Manager who will be managing the Design Review Team (DRT) design review process for assigned project(s) through all phases of design including significant design changes during construction</li><li>
Monitoring and leading efforts related to the permitting process required by the design team and contractor</li><li>
Overseeing the construction process to remove and mitigate obstacles that cause inefficiencies to the construction process</li><li>
Becoming thoroughly familiar with required contractual obligations and technical aspects of all facilities to be erected</li><li>
Ensuring all work is being performed with and inspected to the latest versions of plans and specifications including approved changes, submittals, and RFI&rsquo;s</li><li>
Working with designer, contractor and stakeholders to develop the overall planning of construction activities and identifying critical milestones and priorities</li><li>
Keeping alert to possible problem areas and taking preventative action to ensure critical milestones are met for each phase of the project</li><li>
Ensuring the use of safe and sound constructi on practices<br>
</li><li>
Preparing reports summarizing progress of construction activities for senior management<br>
</li><li>
Reviewing change proposals for contractual compliance and alignment with fair market value<br>
</li><li>
Preparing a monthly risk report for the Program Board<br>
</li><li>
Monitoring adherence to Quality Assurance/Quality Control Plan, and other documents as required and promoting excellence on the project through the application of Quality Assurance processes<br>
</li><li>
Enforcing the program requirements for all areas of the project and monitoring the draft and final deliverables for adherence to these criteria<br>
</li><li>
Reviewing pay applications to ensure proper verification of completed work and compliance with contract requirements<br>
</li><li>
Working with the key project individual to devise and execute action plans to rectify potential cost overruns or delays, or to accommodate significant changes to the scope of work<br>
</li><li>
Assuring that current and timely change orders are documented and administered properly<br>
</li><li>
Participating in all necessary coordination meeting with designer, contractor and stakeholders<br>
</li><li>
Managing the closeout process to ensure all documentation is completed as quickly as possible to efficiently close the project without incurring unnecessary costs<br>
</li><li>
Safety performance well above industry standards</li></ul><br>
<ul><li>
10 years or more experience</li><li>
Bachelor&rsquo;s degree in Architecture, Engineering, Construction Management, Planning or other related technical field required</li><li>
Optional certifications may include AAAE, LEED, PE, PMP, AICP, etc. or any other relevant professional license or certifications.</li><li>
DBIA certification strongly preferred</li><li>
Experience with projects more than $40 million in value.</li><li>
Experience with Design-Build Delivery and specifically Progressive Design-Build</li><li>
Proven ability to perform in a management capacity</li><li>
Excellent written and oral communication skills and a thorough knowledge of industry practices and regulations</li><li>
Proficient in Microsoft Office Suite and Bluebeam</li><li>
Proficient in Project Management / Project Controls software</li></ul><div>
Salary Range: $145,000 to $165,000 yearly</div><div>
Location: Los Angeles, CA</div><div>
Work Environment: Onsite</div></div>

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