administrative assistant - clinical services Jobs in San Francisco

administrative assistant - clinical services

clinical research coordinator Jobs in San Francisco

clinical research coordinator

clinical research coordinator (supplements) Jobs in San Francisco

clinical research coordinator (supplements)

compliance testing manager Jobs in San Francisco

compliance testing manager

director of behavioral health Jobs in San Francisco

director of behavioral health

director clinical monitoring oversight

Olema Oncology

<div><div>Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you're ready to join us at the edge of something unstoppable, let's make a profound impact together for our patients, for your career, for what's beyond.

You can view our latest corporate deck and other presentations here.</div>
About the Role &gt;&gt;&gt; Director, Clinical Monitoring Oversight

As the Director, Clinical Monitoring Oversight, reporting to the Senior Director, Clinical Operations, you will provide strategic and operational leadership for global clinical site monitoring activities across Olema's clinical programs. You will ensure that clinical monitoring &ndash; whether by internal teams, through Functional Service Providers (FSPs), or outsourced to Clinical Research Organizations (CROs) &ndash; is executed with high standards of quality and consistency while maintaining compliance with GCP regulations. You will oversee Olema's Clinical Monitoring Oversight Leads, regional monitoring teams, and site performance. As the Director, Clinical Monitoring Oversight, you will develop and implement monitoring oversight strategies and standards for Olema's clinical monitoring execution worldwide&mdash;driving operational excellence, data integrity, and inspection readiness across all trials with an emphasis on risk-based, data driven processes.

This role is based out of either our Boston, MA or San Francisco, CA office and will require about travel 15% travel.
Your work will primarily encompass:
<ul>
<li>Provide strategic direction and operational oversight of all global monitoring activities across Olema's clinical programs</li>
<li>Oversee internal clinical monitoring oversight team and FSP vendor responsible for providing Regional Site Monitoring Leads (RSMLs), ensuring alignment, consistency, and accountability across global regions</li>
<li>Establish and maintain effective governance with the FSP partner, including performance management, risk mitigation, and continuous improvement in monitoring quality and efficiency</li>
<li>Define and implement Olema's monitoring strategy, including risk-based and centralized monitoring approaches in alignment with ICH-GCP and regulatory expectations</li>
<li>Ensure global harmonization of clinical monitoring processes, training, and documentation across programs and regions</li>
<li>Develop and monitor key performance indicators (KPIs) and quality metrics to evaluate site performance, FSP delivery, and regional oversight effectiveness</li>
<li>Collaborate with Clinical Operations, Data Management, Clinical Quality, and Clinical Development to ensure monitoring activities are aligned with program objectives and timelines</li>
<li>Contribute to the development and review of key operational documents, including Monitoring Plans, Oversight Plans, Risk Management Plans, and audit/inspection responses</li>
<li>Proactively assess monitoring risks and implement mitigation strategies to maintain inspection readiness</li>
<li>Lead, manage, and mentor internal monitoring oversight staff, fostering collaboration, accountability, and continuous improvement</li>
<li>Serve as the Monitoring Oversight representative on cross-functional and governance teams, presenting program updates, risks, and mitigation strategies to senior management</li>
<li>Drive innovation and process optimization in monitoring oversight practices, including leveraging technology and data analytics to enhance quality and efficiency</li>
</ul>
 Ideal Candidate Profile &gt;&gt;&gt;

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge:
<ul>
<li>Bachelor's or Master's degree in a scientific discipline or a related scientific field is required</li>
<li>Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements related to monitoring and clinical trial conduct</li>
</ul>
 Experience:
<ul>
<li>Minimum 12 years of clinical operations experience in the pharmaceutical or biotech industry</li>
<li>Minimum 5 years direct site monitoring experience (qualification, initiation, interim, and close-out visits) with strong understanding of site operations and clinical trial execution</li>
<li>Minimum 5 years in a role providing global monitoring oversight, including oversight of clinical site monitors, FSP/CRO management and oversight, monitoring quality metrics, KPIs, and governance, and a track record of driving performance improvement and corrective action plans</li>
<li>Experience overseeing regional monitoring functions and ensuring alignment across geographically distributed teams</li>
<li>Oncology experience is required
 </li></ul>Attributes:
<ul>
<li>Demonstrated ability to manage FSP or CRO partnerships, including contract governance, KPI development, and issue escalation</li>
<li>Skilled in risk-based monitoring methodologies and the use of oversight tools and systems</li>
<li>Strategic thinker with excellent communication, leadership, and interpersonal skills, with the ability to influence cross-functionally and externally</li>
<li>Strong analytical and problem-solving abilities; adept at managing competing priorities in a fast-paced environment</li>
</ul>
The base pay range for this position is expected to be $235,000 - $250,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-CK1<div>
Important Information &gt;&gt;&gt;
We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.

Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.

Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema's official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.</div></div>

Director, Clinical Monitoring Oversight

MENTAL HEALTH ASSOCIATION OF SAN FRANCISCO

<div>Overview of Position:
The Bilingual Senior Peer Program Manager works in collaboration with MHASF's Director of Community Programs to provide management of the Marin CAT &amp; MCRT Program daily operations of the crisis-related, follow-up, and crisis aftercare services of the program.
The Program Manager conducts weekly individual supervision meetings and monthly group supervision for the Peer Support Specialists; they will work with Marin Behavioral Health and Recovery Services (BHRS) Unit Supervisors to collaborate and communicate effectively monthly, and they are available during MHASF business hours (Monday - Friday 8 am to 6 pm) to provide on-call consult for HR support, crisis intervention, and debriefing.
The Program Manager additionally will hold a half-time caseload of active clients, be available to respond to mobile crisis calls in-the-field, and they will be required to be a Medi-Cal Certified Peer Support Specialist or achieve that certification within the first 6 months of hire.
Responsibilities:
Top Three Responsibilities:<ul><li>
Serve as a liaison among the various BHRS programs, clinical teams, and MHASF Peer Support Specialists</li><li>
Daily management of program operations including SmartCare E.H.R. documentation review, bi-monthly billing and finance oversight, and monthly check-ins with BHRS contract representatives</li><li>
Manage and provide oversight for program deadlines, data collection, outcome measurement, and reporting</li></ul>
Marin TOT &amp; MCRT Program:<ul><li>
Direct management and weekly 1:1 supervision of Peer Support Specialists and Group Supervision of Peer Support Specialists</li><li>
Serve as a liaison among the various BHRS program sites, clinical teams, peer counselors, and MHASF staff</li><li>
Attend clinical team meetings at BHRS programs; communicate with Unit Supervisors about program opportunities and challenges</li><li>
Oversee the recruitment and retention process in conjunction with HR, Associate Director of Peer Services and BHRS teams for interview panels and final hiring decisions</li><li>
Ensure that Peer Specialists have the necessary resources needed to perform their jobs well</li><li>
Develop and maintain strong working relationships with agency partners, consumer advocates, and other entities supporting the program</li><li>
Support Associate Director of Peer Services in the development of policies and procedures</li><li>
Continuous quality improvement and evaluation of programs and program policies on an ongoing basis</li><li>
Assist in the development of Department goals and objectives</li><li>
Ability to travel to local and regional training sites and meetings</li><li>
Communicate with Associate Director of Peer Services about program challenges and opportunities</li><li>
Ensure quality assurance of program documents, data collection, and materials</li><li>
Offer debriefing meetings and support for staff responding to crisis situations</li><li>
Provide training and QI/QA of case note documentation, adhering to Medi-Cal guidelines, in SmartCare.</li></ul>
HIPAA Compliance and Program Confidentiality:<ul><li>
Exercises reasonable care and caution in protection confidential and sensitive information related to clients and personnel</li><li>
Maintains confidentiality of team, personnel, and client information</li><li>
Works with MHASF program directors to assure quality assurance of program materials as it is related to HIPAA compliance and program confidence</li></ul>
Record-Keeping, Training, &amp; Participation:<ul><li>
Attend supervision, staff meetings, and trainings</li><li>
Utilize MHASF systems of remote communication (Slack, Asana, Outlook, Zoom, SharePoint, OneDrive)</li><li>
Utilize Marin BHRS client record databases (Clinician's Gateway, CSU Log, and MAA Billing)</li><li>
Maintain detailed records of services provided and ensure participant record confidentiality</li><li>
Ensure records contain all data necessary in reporting to the State Department of Mental Health</li><li>
Ensure records conform to Medi-Cal and HIPAA requirements and standards</li></ul>
As job descriptions cannot be exhaustive, the above list of responsibilities is intended to provide a general overview of duties to be assigned and in no way is a comprehensive list of position duties and responsibilities.
Required Qualifications:<ul><li>
Must be or willing to become a Certified Peer Support Specialist or fall under the designation of a Licensed Practitioner of the Healing Arts (LPHA) in California within 6-months of hire</li><li>
Bilingual and able to read, write, and speak Spanish proficiently</li><li>
Personal lived experience of mental health challenges, and/or experience supporting a family member through mental health challenges</li><li>
Proof of COVID-19 vaccination including booster(s)</li><li>
Ability to drive throughout Marin County in one's own personal vehicle for work-related purposes; clean driving record (reimbursement for mileage is provided)</li><li>
Minimum of 2 years of progressive professional working experience in a nonprofit and/or social service with a minimum of 1 year in team management roles</li><li>
Excellent understanding of mental illness diagnoses, symptoms, and impact of stigma on participants</li><li>
Commitment to participant empowerment, culturally competent services, and a nonjudgmental approach</li><li>
Demonstrated success developing and evaluating program models and selecting and successfully operationalizing innovative programs</li><li>
Deep familiarity with mental health recovery resources and programs</li><li>
Strong project management skills managing complex, multifaceted projects resulting in measurable successes and program growth</li><li>
Strength in hiring, recruiting, managing, developing, coaching, and retaining individuals and teams, empowering them to elevate their levels of responsibility, span-of-control and performance</li><li>
Deep understanding of HR, employee performance improvement plans, and corrective action policies</li><li>
Managing complex systems and experience negotiating win-win agreements</li><li>
Highly organized and resourceful, excellent attention to detail, ability to multi-task and manage time well to accomplish all key tasks and deadlines</li><li>
Excellent computer skills including internet, Microsoft Word, Excel, and PowerPoint</li><li>
Collaborative team working style with ability to relate effectively with people from diverse backgrounds</li><li>
Commitment to the mission, vision and values of MHASF</li></ul>
Desirable Qualifications:<ul><li>
Have at least four years of nonprofit management experience</li><li>
Experience with city, county, State, and foundation contract management and reporting</li><li>
Individuals with lived experience of mental illness/psychiatric disabilities, or substance use</li><li>
Experience in Medi-Cal billing</li></ul>
Physical Requirements
The position requires long periods of work at a desk, which may involve sitting or standing and the use of a computer, keyboard, mouse, and desk phone. The office building and between floors of the building, and to travel short distances (under 1 mile) is required. Other physical tasks may involve reaching, pulling, pushing, bending, climbing a stepladder, use of a dolly to move items weighing up to 50 lbs., and lifting and carrying up to 20 lbs.</div>

Bilingual Senior Peer Program Manager

Marin City Health and Wellness Center

<div>Summary:
The Marin City Health &amp; Wellness Center Behavioral Health Director is responsible for administering, maintaining and expanding a program of primary (and in selected instances, secondary care) and Preventive Behavioral/Mental Health care in a community health center setting. The Behavioral Health Director supervises the Behavioral Health staff of the community health center and represents the Behavioral Health staff to the Executive Director. The Behavioral Health Director provides Behavioral Health advice and counsel to the Executive Director and the Board of Directors of the corporation. 

Essential Duties and Responsibilities:
<ul>
<li>Attends scheduled sessions and implements one-to-one behavior intervention services with clients</li>
<li>Records patient-psychologist transactions as they occur in the patient&rsquo;s Behavioral Health record so that the Behavioral Health record accurately and completely reflects the nature of the contact, the condition of the patient and the care or treatment provided. In addition the Behavioral Health Director shall complete referrals, data collections instruments and other records or paper works as shall be required from time to time by the corporation.</li>
<li>Educates individuals in the nature of behavioral health related conditions and in the general promotion of behavioral health related disease prevention.</li>
<li>Serves on the behavioral health staff and other center committees as assigned. Serves as Chair of the Behavioral Health Department&rsquo;s CQI committee and Peer Review Committee.</li>
<li>Prepares and submits monthly written reports on Behavioral Health Department issues, concerns, programs status, initiatives, and progress to the Clinical Director for submission to the Executive Director and the Board of Directors. Prepares specific reports as requested by the community health center&rsquo;s Executive Director.</li>
<li>Assists in the provision of continuing education, on-the-job training, and the orientation of community health center staff as requested.</li>
<li>Designs, develops, and implements appropriate Behavioral Health Department policies, protocols and procedures which are in compliance with the most current accepted professional standards.</li>
<li>Assists in the provision of technical assistance and health education to the community as requested.</li>
<li>Assists in the preparation of an operating budget for the Behavioral Health Department and in conjunction with the Chief Financial Officer and oversees compliance with the Behavioral Health Department&rsquo;s budget. In addition, the Behavioral Health Director shall prepare special grant and project budgets as required to meet the goals of the corporation.</li>
<li>Participates in short and long term program planning for the Behavioral Health Department and the agency, including development of goals and objectives.</li>
<li>Provides consultation to the Executive Director and the Board of Directors regarding behavioral health and behavioral health issues.</li>
<li>Travels when necessary to fulfill the corporation&rsquo;s needs and attends meetings as necessary to represent the corporation and/or the Behavioral Health Department.</li>
<li>Participates in the preparation of grant applications for the corporation and assumes primary responsibility for developing and implementing the corporation&rsquo;s Behavioral Health care plan.</li>
<li>Assists in the coordination and integration of the corporation&rsquo;s Behavioral Health programs and services with other corporate programs and services for the welfare of the corporation&rsquo;s patients.</li>
<li>Performs periodic evaluations of all Behavioral Health Department professional providers as directed by the policy of the corporation.</li>
<li>Supervises, advises, counsels and disciplines all Behavioral Health Department professional providers in conjunction with the Executive Director of the corporation and approves leave status for Behavioral Health Department professional providers and ancillary staff.</li></ul> 

<ul>
<li>Responsible for personal as well as Departmental full compliance with all applicable federal, state, local and center rules, regulations, protocols and procedures governing the practice of dentistry and the clinical provision of Behavioral Health care as well as those relating to, but not limited to, personnel issues, work place safety, public health and confidentiality.</li>
<li>Participates in recruitment/retention activities of the corporation as necessary.</li>
<li>As directed by the Executive Director, performs other related and/or necessary tasks to achieve organizational and programmatic goals and objectives.</li></ul> 


Supervisory Responsibility:
<ul><li>Clinical Psychologist, Licensed Clinical Social Worker, Marriage and Family Therapist Intern, Behavioral Health Coordinator</li></ul> 


Qualification Requirements: 
 
 
Education and/or Experience:
<ul>
<li>Current State of California license in Clinical Psychology required</li>
<li>Psy. D or Ph.D in Clinical Psychology</li>
</ul><ul><li>2 years minimum recent clinical experience</li>
<li>Experience working in an outpatient community healthcare clinic preferred</li></ul> 


Language Skill:
<ul>
<li>Must possess excellent organization, writing, and verbal skills</li>
<li>English proficiency required; Spanish proficiency preferred</li></ul> 


Reasoning ability:
<ul>
<li>Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.</li></ul> 


Equipment/Machinery: Fax machine, copier, personal computer, telephone, calculator, Microsoft Word/Excel, EHR system, and other software as required. 
Physical Demands: The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

<div>
<ul><li>Stand and walk or sit alternatively depending on specific needs of day. Estimate 20% of time is spent on feet and 80% sitting at desk.</li></ul>
<ul><li>Have occasional need to perform the following physical activities: bend/stoop/squat, climb stairs, push or pull, reach above shoulders.</li></ul>
<ul><li>Have occasional need to perform standing and walking activities.</li></ul>
<ul><li>Constant need to perform the following physical activities: writing/typing, grasping/turning, finger dexterity.</li></ul>
<ul><li>Lifting/carrying over 10 pounds occasionally. Lifting/carrying less than 10 pounds frequently.</li></ul>
<ul><li>Vision requirements: constant need to complete forms, read reports, view computer screen. Frequent need to see small detail. Frequent need to see things clearly beyond arm's reach.</li></ul>
<ul><li>Hearing requirements: constant need to communicate over telephone and in person.</li></ul></div> 


Travel Requirements: Occasional need to utilize personal transportation to visit sites, and attend meetings and conferences. 


Work Environment:

The noise level in the work environment is usually moderate.</div>

Director of Behavioral Health

University of California - San Francisco

<div><div><div><div>Coordinator will perform independently or with general direction at the fully operational journey level of the 
series to execute, manage, and coordinate research protocols, as directed by the Clinical Research Supervisor in 
the Department of Surgery as part of the Clinical Research Core. Under the Clinical Research Core, the Clinical Research will be assigned studies across the 7 divisions in the department based on Principal Investigator needs; may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies. 
 
Incumbent&rsquo;s duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and 
manage databases and comprehensive datasets and reports; coordinate staff work schedules, assist the Clinical 
Research Supervisor with study start up activities, and assist Clinical Research Supervisor and/or PI with oversight of 
other research staff; manage Investigator&rsquo;s protocols in the Committee on Human Research online system, as 
well as renewals and modifications of protocol applications and the implementation of new studies; participate in 
the review and writing of protocols to ensure institutional review board approval within University compliance; 
help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and 
maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study 
initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal 
and external audits or reviews of study protocols; and perform other duties as assigned. 
The final salary and offer components are subject to additional approvals based on UC policy.
Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.
The salary range for this position is $34.32 - $55.19 (Hourly Rate).
To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html</div>
</div><div>Department Description
<div>The mission of the UCSF Department of Surgery is threefold: to develop the next generation of leaders in surgery; to provide outstanding quality clinical care that is cost effective, yet compassionate; and to make significant advances in scientific knowledge and clinical practice through basic and clinical research. The Department is comprised of multiple divisions and sections and our surgeons provide care at locations throughout the greater San Francisco Bay Area and beyond. Our Residents and Fellows also play a critical role in Department&rsquo;s success. The Department of Surgery Chair&rsquo;s Office is an extremely high profile, fast paced environment with a very diverse range of contacts and needs which require an immediate and accurate response, handled with confidentiality, and while staying compliant. The Chair's Office is responsible for management, direction and oversight of over 400 faculty (clinical and research), trainees and staff personnel.</div>
</div><div>Required Qualifications
<ul><li>HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.</li><li>Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions and companies; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.</li><li>Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.</li></ul>
</div><div>Preferred Qualifications
<ul><li>Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system.</li><li>Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.</li><li>Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals</li><li>Experience with electronic medical records.</li><li>Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.</li><li>Experience applying the following regulations and guidelines:</li></ul>
Good Clinical Practice Guidelines 
Health Information and Accountability Act (HIPAA) 
The Protection of Human Research Subjects 
CHR regulations for recruitment and consent of research subjects 
Effective Cash Handling Procedures 
Environmental Health and Safety Training 
Fire Safety Training 
<ul><li>BA/BS with biology coursework included</li></ul>
</div><div>About UCSF
<div>The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world&rsquo;s leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.</div>
</div><div>Pride Values
<div>UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence &ndash; also known as our PRIDE values.
 
 
In addition to our PRIDE values, UCSF is committed to equity &ndash; both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu
 
 
Join us to find a rewarding career contributing to improving healthcare worldwide.</div>
</div><div>Equal Employment Opportunity
<div>The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.</div>
</div><div>Organization
<div>Campus</div>
</div><div>Job Code and Payroll Title
<div>009335 CLIN RSCH CRD
</div></div><div>Job Category
<div>Research and Scientific</div>
</div><div>Bargaining Unit
<div>University Professional Technical Employees &ndash; Research Support Professionals Unit (UPTE-RX)
</div></div><div>Employee Class
<div>Career</div>
</div><div>Percentage
<div>100%</div>
</div><div>Location
<div>San Francisco, CA
</div></div><div>Campus
<div>Parnassus Heights (SF)
</div></div><div>Work Style
<div>Fully On-Site</div>
</div><div>Shift
<div>Days</div>
</div><div>Shift Length
<div>8 Hours
</div></div><div>Additional Shift Details
<div>Mon-Fri, 8-5, occasional after work hours</div></div></div></div><div></div>

Clinical Research Coordinator

SF Research Institute Inc.

Clinical Research CoordinatorHave strong coordinator experience at a private site level. Ideally in Personal Care, Skin Care, Dietary Supplements and for industry-sponsored studies.Job Description:1. Study CoordinationCoordinate, monitor, and supervise all aspects of clinical studies from start-up to closeout, to ensure proper execution of assigned clinical research trials in Beauty, Personal Care, and SupplementsLead patient recruitment from various sources, expand recruitment source, recruit, screen, and enroll patients into studiesCommunicate and work with sponsors, research team, including phlebotomists, coordinators, and assistants, and labs to ensure that study protocols are metLearn to use all advanced skin research instruments including maintaining proper functioning and scheduled calibration of all research equipmentObtain vital signs as required per protocol (i.e., blood pressure, temperature, heart rate, waist measurement, weight &amp; height), facilitate blood draws, urine, and stool collection (if necessary), and package, process, and ship specimen to labsFill and track study visits, survey documents, including monitoring reports and study source documentsCertification in Phlebotomy is desirableJob Types: Full-time, Contract, TemporaryPay: $70,000.00 - $90,000.00 per yearWork Location: In person

Clinical Research Coordinator (Supplements)

<div><div>Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you're ready to join us at the edge of something unstoppable, let's make a profound impact together for our patients, for your career, for what's beyond.

You can view our latest corporate deck and other presentations here.</div>
About the Role &gt;&gt;&gt; Senior Director, Biostatistics

As the Senior Director of Biostatistics, reporting to the VP of Biostatistics, you will play an instrumental role in leading the statistical strategy and execution of a pivotal Phase 3 clinical trial and all associated NDA activities. You will leverage your technical expertise to apply and share knowledge of appropriate statistical methods for clinical trial design and data analysis. Additionally, you will collaborate cross-functionally to support the planning, execution, and analysis of the trial.
This role is based in either our San Francisco, CA or Cambridge, MA office and will require minimal travel (about 10%).

Your work will primarily encompass:
<ul>
<li>Lead the biostatistics strategy and execution for a pivotal Phase 3 trial and ISS/ISE, ensuring scientific rigor and global regulatory alignment.</li>
</ul><ul><li>Apply innovative statistical methods to optimize study design, analysis strategies, and data interpretation.</li>
</ul><ul><li>Develop and author key statistical documents.</li>
</ul><ul><li>Lead statistical activities for regulatory submissions and prepare briefing materials for health authority interactions.</li>
</ul><ul><li>Provide statistical input for CSRs, IBs, DSURs, and other study-level and submission documents.</li>
</ul><ul><li>Oversee development of SDTM, ADaM, and TLF deliverables to ensure accuracy and compliance with regulatory and CDISC standards.</li>
</ul><ul><li>Manage CRO statistical activities, including DMC deliverables, to ensure high-quality execution.</li>
</ul><ul><li>Manage and mentor junior statisticians as applicable.</li>
</ul><ul><li>Provide statistical leadership across multiple projects with overlapping timelines, as needed.</li></ul> 


Ideal Candidate Profile &gt;&gt;&gt;

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge:
<ul>
<li>Strong understanding of regulatory requirements, industry standards, and guidance documents.</li>
</ul><ul><li>Broad and thorough knowledge of statistical principles and clinical trial methodology, with the ability to apply best practices in oncology study design and analysis.</li>
</ul><ul><li>Comprehensive understanding of RECIST 1.1 guidelines.</li>
</ul><ul><li>Expertise in CDISC standards, including SDTM and ADaM.</li>
</ul><ul><li>Proficiency in SAS and/or R programming.</li>
</ul><ul><li>Demonstrated ability to lead and successfully complete major programs and projects.</li>
</ul><ul><li>Strong analytical, problem-solving, and communication skills.</li>
<li>Experience interacting with regulatory agencies, including the FDA and international health authorities.</li>
</ul>
Experience:
<ul>
<li>10+ years of experience in the biotech or pharmaceutical industry, with a PhD in Statistics or Biostatistics.</li>
</ul><ul><li>Minimum of 3 years direct leadership experience.</li>
</ul><ul><li>Extensive experience in late-stage oncology drug development, including the design and execution of registrational Phase 3 studies.</li>
</ul><ul><li>Proven experience in regulatory interactions, with a strong track record of NDA or sNDA submissions.</li>
</ul><ul><li>Experience building a biostatistics strategy and execution of a global NDA submission (Phase 3, ISS, ISE)</li>
</ul><ul><li>Demonstrated ability to manage CROs in the conduct and analysis of clinical trials.</li>
</ul><ul><li>Proven ability to represent Biostatistics effectively in multidisciplinary meetings.</li>
</ul><ul><li>Strong history of effective collaboration across cross-functional teams.</li></ul> 


Attributes:
<ul>
<li>Strong leadership skills, including proactive strategic thinking, prioritization, adaptability, conflict resolution, and partnership-building.</li>
</ul><ul><li>Deep statistical expertise and experience overseeing the statistical components of clinical trials.</li>
</ul><ul><li>Ability to develop innovative and creative statistical and technical solutions to complex problems.</li>
</ul><ul><li>Excellent verbal and written communication skills.</li>
</ul><ul><li>Commitment to excellence and consistently delivering high-quality work.</li>
</ul><ul><li>Self-motivated and enthusiastic, with the ability to quickly learn, identify core project challenges, and adapt to evolving requirements in a fast-paced environment.</li>
</ul><ul><li>Possesses impeccable professional ethics, integrity, and judgment.</li>
</ul>
The base pay range for this position is expected to be $292,000 - $308,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MK1<div>
Important Information &gt;&gt;&gt;
We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.

Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.

Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema's official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.</div></div>

Senior Director, Biostatistics

Golden Gate Regional Center

<div>Administrative Assistant - Clinical Services
Starting Salary Range: $47,618 - $57,141
GGRC is looking to hire a Administrative Assistant to provide support to the Manager, Clinical Services, compile required documents for appeals, and general and medical administrative direction for the department as a whole.
Responsibilities:
<ul><li>Department Support</li>
<li><ul><li>Provide administrative support within the department by taking initiative, anticipating needs and carrying out projects in a timely manner within delegated scope of authority.</li>
<li>Establish, maintain, and update files, databases, records and/or other documents develops, maintains and performs routine analyses and calculations of data for internal reports.</li>
<li>Compose and prepare highly specialized correspondence
</li><li>Serve as a liaison with other departments in the resolution of day-to-day administrative and operational problems.</li>
<li>Respond to internal and external inquiries by phone, email, and in person and redirect as necessary</li>
<li>Compile and prepare documents for appeals, state level fair hearing for eligibility, discussion with attorneys and judges, other legal issues such a subpoena for records and court ordered evaluations</li>
<li>Assists manager and staff in problem solving, project planning, and development and execution of stated goals and objectives.</li>
<li>Attend meetings as assigned; may prepare, edit, and distribute agendas and/or minutes of meetings.</li>
<li>Schedule and coordinates meetings, events, appointments, and/or other similar activities for supervisor.</li>
<li>Maintain files and confidential material for the Director, Clinical Services</li>
<li>Coordinate clinical service unit activities and staff schedules</li>
</ul></li><li>Clinical Administration</li>
<li><ul><li>Perform assigned functions in processing documents for final approval
</li><li>Collect information for data, compile reports in support of assigned projects and research activities</li>
<li>Gather background material to establish the need for further diagnostic genetic studies, check with Manager, Clinical Services for unusual requests and have direct discussions with families and persons at risk (status 3)</li>
<li>Coordinate authorization and payments for amniocentesis (medical procedure used in prenatal diagnosis of chromosomal abnormalities and fetal infections, and also used for sex determination)
</li><li>Review and process requests for medical consent</li>
<li>Track completion of eligibility reports from clinical staff</li>
<li>Prepare and finalize specialized assessment medical and psychological reports when necessary</li>
<li>Prepare and maintain files for personnel supported Mortality Review Committee</li>
<li>Maintain and coordinate registration conferences for continuing education for staff, and make necessary travel arrangements</li>
<li>Assist other members of the Management Advisory Committee (MAC) as requested</li>
<li>Act as a backup support to Executive Administrative Assistant and Administrative Assistant-Regional Center Services as needed</li>
</ul></li><li>Participate in special projects, and assist with additional duties or tasks, as assigned</li>
<li>Maintain all client information as confidential in compliance with the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the California Lanterman Act</li>
</ul>
Requirements
Education/Experience
<ul><li>College education or equivalent
</li><li>Relevant work experience in healthcare field preferred</li>
</ul>
Competencies
<ul><li>Creative Problem Solving
</li><li>Customer service orientation</li>
<li>Organizational skills</li>
<li>Time management</li>
<li>Attention to detail</li>
<li>Adaptability
</li><li>Collaboration/teamwork</li>
<li>Self direction</li>
<li>Initiative
</li></ul>General Skills<ul>
<li>
Written communication: ability to develop standard business communications, using proper grammar, spelling and punctuation</li>
<li>Oral communication: ability to convey complex information and ideas in a clear, concise and professional manner</li>
<li>Ability to operate basic office equipment, including scanners, copiers, faxes, phones</li>
<li>Intermediate knowledge of MS Word&reg; (e.g. tables, mail merges, form creation), MS Excel&reg; (e.g. Pivot tables, Lookup graphing), MS PowerPoint&reg;, MS Outlook&reg; (e.g. group list management, multi-calendar management)</li>
<li>Ability to use internal records system
</li><li>Ability to type 60 wpm</li>
<li>Use of discretion and ability to maintain confidentiality</li>
</ul>
Desired Qualifications
<ul><li>Experience in multi-cultural settings and/or multi-lingual capacity</li></ul>
Benefits
What are the benefits to working with GGRC?
We offer a comprehensive benefits package including Medical and Dental benefits with a generous employer contribution and additional employer paid Life, Disability and Vision coverage
10% employer contribution to a 403(b) retirement account to help you save for the future!
GENEROUS TIME OFF BENEFITS!!!
No really, we mean generous:
13 vacation days, 15 sick days, 11 paid holidays, 6 personal holidays, and up to 5 paid days for continuing education
What makes GGRC so special?
GGRC values diversity, we believe in creating an environment where people of all backgrounds can collaborate to find solutions to complex problems. We are community minded and passionate.
GGRC values each person as a full, robust, and unique individual and interacts with each person in a manner that is respectful and responsive. We endeavor to place each person at the center of his, her or their own life. We approach each person as an expert on his, her or their own life and identity with a clear and attentive inquiry into what is important to, as well as important for, that one person (whether coworker or person-served, family member or other stakeholder).
How to apply:
GGRC values diversity; people of all backgrounds are encouraged to apply. Please complete the application and submit your most recent resume. If you feel that the questions do not accurately capture what you have to offer Golden Gate Regional Center, you are also welcome to attach a cover letter. Applications are being reviewed on a rolling basis so we encourage you to submit yours soon. We look forward to reading your application.
Golden Gate Regional Center is an Equal Opportunity Employer.</div>

Administrative Assistant - Clinical Services

Explore 61+ Director clinical monitoring oversight in San Francisco this December. Find roles across top companies and apply now to boost your career.