Current jobs related to Clinical Records Associate, TMF Operations - Emeryville, California - 4D Molecular Therapeutics
-
Chief Quality Officer for Healthcare Facility
3 weeks ago
Emeryville, California, United States Clinical Management Consultants Full timePosition OverviewWe are seeking a Chief Quality Officer to lead our quality management initiatives within a distinguished healthcare organization. This role is ideal for an experienced professional who is passionate about enhancing patient care and operational excellence.Key ResponsibilitiesOversee the development and implementation of quality improvement...
-
Clinical Budget Development Specialist
3 weeks ago
Emeryville, California, United States BeiGene Full timeAbout the RoleWe are seeking a highly skilled Clinical Budget Development Specialist to join our team at BeiGene. As an Associate Site Budget Development and Investigator Payment Management Expert, you will play a critical role in supporting the creation of site budget templates leveraging Fair Market Value (FMV) analysis.Key ResponsibilitiesDevelop Global...
-
Clinical Budget Development Specialist
3 weeks ago
Emeryville, California, United States BeiGene Full timeAbout the RoleWe are seeking a highly skilled Clinical Budget Development Specialist to join our team at BeiGene. As an Associate Site Budget Development and Investigator Payment Management Expert, you will play a critical role in supporting the creation of site budget templates leveraging Fair Market Value (FMV) analysis.Key ResponsibilitiesDevelop Global...
-
Lead Clinical Research Specialist
3 weeks ago
Emeryville, California, United States BeiGene Full timeOverview: The Lead Clinical Research Specialist (LCRS) plays a pivotal role in overseeing and managing clinical study sites, ensuring the integrity of data and the safety of participants in alignment with ICH-GCP standards, local regulations, and relevant SOPs.The LCRS works closely with Clinical Study Teams (CSTs) to facilitate daily clinical study...
-
Clinical Nurse Specialist
2 weeks ago
Emeryville, California, United States MFS Talent Full timeJob SummaryMFS Talent is seeking a highly skilled Clinical Nurse to join our team. As a Clinical Nurse, you will be responsible for providing high-quality patient care and working collaboratively with our healthcare professionals to ensure the best possible outcomes.Key ResponsibilitiesAssessment and Prioritization: Assess and prioritize patient conditions,...
-
Retail Sales Associate
2 weeks ago
Emeryville, California, United States Goodwill of San Francisco Bay Full timeAbout the RoleWe are seeking a highly motivated and customer-focused Retail Sales Associate to join our team at Goodwill of San Francisco Bay. As a Retail Sales Associate, you will play a critical role in providing excellent customer service, maintaining a clean and organized retail environment, and implementing our company's mission and goals.Key...
-
Pharmacist - Clinical Services
2 weeks ago
Emeryville, California, United States Stanford Health Care Full timeJob SummaryStanford Health Care is seeking a highly skilled Clinical Pharmacist to join our team. As a Clinical Pharmacist, you will be responsible for providing a range of pharmaceutical services, including clinical, consultative, research, and administrative support.Key ResponsibilitiesProvide clinical pharmacy services, including medication therapy...
-
Clinical Leader, Women's Health Service Line
2 weeks ago
Emeryville, California, United States Sutter Health Full timeJob SummarySutter Health is seeking an experienced and visionary leader to serve as the Executive Director of our Women's Health Service Line. This is a unique opportunity to lead a team of healthcare professionals in delivering high-quality patient care and advancing the field of women's health.Key ResponsibilitiesDevelop and implement strategic plans to...
-
Retail Sales Associate
2 weeks ago
Emeryville, California, United States Goodwill of San Francisco Bay Full timeAbout the RoleWe are seeking a highly motivated and customer-focused Retail Sales Associate to join our team at Goodwill of San Francisco Bay. As a Retail Sales Associate, you will play a critical role in providing excellent customer service, maintaining a clean and organized retail environment, and implementing our company's mission and goals.Key...
-
Delivery Associate
1 week ago
Emeryville, California, United States Ohana Cannabis Co. Full timeAbout Ohana Cannabis Co.We are a leading cannabis company dedicated to providing exceptional customer service and a unique shopping experience. Our team is passionate about helping customers find the perfect products to enhance their well-being.Job SummaryWe are seeking a skilled Delivery Associate to join our team. As a Delivery Associate, you will be...
-
Clinical Psychologist
2 weeks ago
Emeryville, California, United States Kaiser Full timeJob Summary:As a Clinical Psychologist at Kaiser Permanente, you will play a vital role in providing mental health assessment, diagnosis, and treatment services to adult and child members. You will collaborate with a multidisciplinary team to develop and implement individualized treatment plans, ensuring the best possible outcomes for our patients.Key...
-
Protein Science Research Associate
3 weeks ago
Emeryville, California, United States IMS People Full timeJob OverviewPosition: Research Associate - Protein ScienceLocation: Emeryville, CAContract Duration: 03 Months W2Position Summary:IMS People is in search of a Research Associate dedicated to the production and purification of antibodies and therapeutic proteins. This role is situated within a collaborative team environment, focusing on advancing our...
-
Front Desk Associate
1 week ago
Emeryville, California, United States Sonesta International Hotels Full timeJob SummaryThe Front Desk Associate is responsible for delivering exceptional guest experiences and ensuring seamless operations at the hotel. This role requires a high level of customer service skills, attention to detail, and ability to work in a fast-paced environment.Key ResponsibilitiesGuest Services: Provide warm and welcoming service to guests,...
-
Clinical Psychologist
2 weeks ago
Emeryville, California, United States Kaiser Full timeJob SummaryAs a Clinical Psychologist at Kaiser Permanente, you will play a vital role in providing mental health assessment, diagnosis, and treatment services to adult and child members. You will collaborate with a multidisciplinary team to develop and implement individualized treatment plans, ensuring the best possible outcomes for our patients.Key...
-
Sales Associate
1 week ago
Emeryville, California, United States OneBBX Full time{"title": "Sales Associate", "description": "At OneBBX, we're on a mission to create an environment that fosters happiness and humor. As a Sales Associate, you'll be part of a dynamic team that's passionate about delivering exceptional customer experiences.**Key Responsibilities:*** Display enthusiasm and promote a cohesive team environment* Represent the...
-
Senior Medical Director
1 week ago
Emeryville, California, United States Kyverna Therapeutics, Inc. Full timeAbout Kyverna Therapeutics, Inc.Kyverna Therapeutics, Inc. is a pioneering biopharmaceutical company dedicated to revolutionizing the treatment of autoimmune diseases through cutting-edge cell therapies.Job SummaryWe are seeking a highly skilled Senior Medical Director - Clinical Development to join our Clinical-IIT organization. As a key member of our team,...
-
Retail Sales Associate
7 days ago
Emeryville, California, United States Ross Stores, Inc. Full time{"title": "Retail Sales Associate", "description": "Job SummaryWe are seeking a highly motivated and customer-focused Retail Sales Associate to join our team at Ross Stores, Inc. As a Retail Sales Associate, you will be responsible for providing exceptional customer service, maintaining a clean and organized store environment, and supporting the sales floor...
-
Litigation Associate
3 weeks ago
Emeryville, California, United States Pop-Up Talent Full timeJob OverviewPosition: Litigation AssociateLocation: Emeryville, CASalary Range: $95,000 - $125,000 annuallyCOMPENSATION PACKAGE:Comprehensive medical and dental coverage fully funded by the employer (PPO or HMO options available)Generous paid time off including vacation, holidays, and sick leave401(k) retirement plan along with a cash pension schemeParking...
-
Sales Associate
2 weeks ago
Emeryville, California, United States OneBBX Full timeAbout the RoleWe are seeking a highly motivated and enthusiastic Sales Associate to join our team at IT'SUGAR. As a Sales Associate, you will be responsible for providing an exceptional customer experience, promoting brand awareness, and driving sales.Key Responsibilities:Display enthusiasm and promote a cohesive group working environmentRepresent the brand...
-
Restaurant Operations Manager
2 weeks ago
Emeryville, California, United States PRP Full timeAbout the RoleThe IHOP Restaurant General Manager is a key member of the PRP team, responsible for overseeing the daily operations of our restaurant. This role requires a strong leader who can manage a team, drive sales growth, and maintain high standards of quality and service.Key ResponsibilitiesOperations Management: Manage all aspects of restaurant...
Clinical Records Associate, TMF Operations
4 months ago
Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.
4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.
We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.
To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.
In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.
Company Differentiators:
• Fully integrated clinical-phase company with internal manufacturing
• Demonstrated ability to move rapidly from idea to IND
• Five candidate products in the clinic and two declared pre-clinical programs
• Robust technology and IP foundation, including our TVE and manufacturing platforms
• Initial product safety and efficacy data substantiates the value of our platforms
• Opportunities to expand to other indications and modalities within genetic medicine
GENERAL SUMMARY:
We are seeking a Clinical Records Associate for our TMF Operations Department Reporting to the Associate Director of TMF Operations. This position is responsible for collecting, reviewing, maintaining, and archiving essential documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and 4DMT's Standard Operating Procedures (SOPs) as appropriate.
RESPONSIBILITIES:
Manage TMF performance objectives for end-to-end processes ensuring quality, timeliness, and completeness throughout the lifecycle of the study by overseeing and/or ensuring ongoing reviews to confirm documents are collected and maintained per ICH guidelines and global regulatory requirements.
Perform the role of the Clinical Records Associate for all Clinical Trials at 4DMT throughout the TMF lifecycle, from study start-up and document collection to oversight and archiving.
Participate in Quality Assurance audits and/or regulatory authority inspections.
Support Study Teams to proactively maintain current Expected Documents List (EDL) counts and to file essential documents promptly according to TMF Plans and Indexes, including adjustments due to unanticipated events during trial conduct.
Identify study-specific TMF compliance gaps (missing or low-quality documents) and track resolutions to closure quickly.
Manage the performance of external vendors responsible for TMF-related deliverables.
Escalate issues and/or process improvement suggestions and collaborate cross-functionally to define and implement solutions, Veeva Vault system changes, or corrective and preventative actions.
Contribute to the development and improvement of department-level and cross-functional Standard Operating Procedures (SOPs), processes, systems, tools.
Other duties as assigned, nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
QUALIFICATIONS:
Education:
Experience:
2 years relevant experience including extensive experience with Veeva Vault TMF.
2+ years of TMF QC Review and knowledge of clinical documentation content required.
Development and maintenance of TMF Plans.
Demonstrated understanding of the DIA Reference Model filing structure and contents.
Knowledge of and ability to apply applicable regulations and guidelines (e.g., ICH/GCP/Good Documentation Practice).
Experience working with cross-functional teams to improve TMF compliance (quality, completeness, and timeliness).
Required Skills:
Expert knowledge of cross-functional TMF content requirements throughout the trial.
Proficiency in Microsoft Office Suite for collaboration with team members.
Especially proficient in Excel for tracking, sorting, filtering, and managing large sets of metadata.
Excellent communication skills (written and verbal).
Interpersonal skills, including conflict resolution in a fast-paced, deadline-driven environment.
Strong attention to detail and organizational skills.
Ability and drive to follow through on detailed tasks to closure.
Analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
Preferred Skills:
Managing CROs performing TMF activities.
Creating and using enterprise system reports to calculate metrics and troubleshoot issues.
All aspects of clinical trial conduct (startup through close-out and TMF Archiving).
Experience with additional Veeva products such as CTMS or Vault RIM.
Experience using collaborative tools like SharePoint and Microsoft Teams and Channels.
Base salary compensation range:
$85,000/yr - $107,000/yr
Bay Area Range:
$95,000/yr - $124,000/yr
Please note that compensation varies on a variety of factors including location, experience, etc.
4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
