- Northern California, CA
- Las Vegas, NV
- Phoenix, AZ
- Bachelor's degree in a related field (life sciences, nursing, etc.).
- Previous experience as a Clinical Research Associate, preferably in ophthalmology or a related therapeutic area.
- Knowledge of ophthalmic diseases, treatments, and related medical terminology, including ophthalmic devices.
- Strong understanding of clinical research regulations and Good Clinical Practice (GCP) guidelines.
- Excellent communication and interpersonal skills.
- Attention to detail and the ability to work independently and as part of a team.
- Willingness to travel as needed for on-site monitoring visits.
- Certification as a Certified Clinical Research Associate / Professional (CCRA / CCRP) or similar credential is a plus.
- Clinical Research Associate required.
- Required 2 years of minimum Ophthalmology experience.
- 3 years of clinical monitoring experience.
- Site coordination.
- Negotiation.
- Good Communication.
- Medical device/Pharma/Biotech would be considered.
- Assist in the selection of investigative sites for clinical trials.
- Conduct site initiation visits to verify that site staff is properly trained and delegated to perform protocol assessments, are familiar with regulatory requirements and understand proper handling and storage of ophthalmic drugs/devices.
- Ensure recruitment strategies are in place to meet enrollment targets.
- Confirm that the site meets the requirements to begin screening subjects.
- Conduct on-site and remote monitoring visits according to the protocol monitoring plan to ensure data quality and regulatory compliance.
- Review source documents, case report forms, and patient records.
- Verify the informed consent process is properly executed and adherence to the study protocol.
- Ensure that instruments/equipment used in the clinical trials are correctly calibrated, maintained, and utilized according to the study protocol and regulatory standards.
- Collaborate with the Clinical Operations Lead and Clinical Trial Team (CTT) to identify and resolve site quality or study execution issues.
- Ensure that the clinical trial sites are compliant with applicable regulatory requirements (e.g., FDA, ICH, GCP, ISO) regarding ophthalmic drugs/devices.
- Ensure that the study sponsor and Investigator Site File are maintained and audit-ready.
- Assists sites and CTT with internal and external audit / inspection-related activities including preparation, defining CAPAs, and ensuring CAPA targets are met.
- Verify subject qualification and correct IP was dispensed/implanted.
- Ensure masking has been maintained, if applicable.
- Confirm full reconciliation of IP at the site level.
- Monitor drug / device-related safety and performance concerns and report them to the study sponsor.
- Ensure proper handling, storage, and accountability of investigational drugs and/or devices.
- Ensures appropriate clinical supplies are available, within the expiry date, and adequate for clinical trial.
- Verify data accuracy and completeness, including instrument/equipment generated data. Ensure data is securely stored.
- Collaborate with the data management team to resolve data-related issues.
- Ensure all safety issues are communicated and managed by the Principal Investigator according to regulatory and protocol requirements.
- Conduct close-out visits to ensure study documentation is complete, finalize data collection, and ensure all study-related activities are completed by the study protocol and regulatory requirements.
- Review Investigator obligations.
- Complete comprehensive and accurate monitoring reports, including site follow-up letters.
- Ensure CTMS and eTMF are up-to-date and audit ready.
-
Research Associate
1 week ago
Belcan Emeryville, United StatesResearch Associate · Job Number: · Category: Research Scientist · Description: Job Title: Research Associate · Pay Rate: Starting at $48 / hr depending on experience · Location: Emeryville, CA · Area Code: 510 · ZIP Code: 94608 · Start Date: Right Away · Shift: 1st shift ...
-
Research Associate
2 weeks ago
Berkeley Lab San Francisco Bay Area, United States Full timeBerkeley Lab's () Biological Systems and Engineering () Division has an opening for a Research Associate to provide technical and research support for microbial culturing, molecular cloning, and genetic transformations. The responsibilities of this position include completing ass ...
-
Research Associate
3 weeks ago
Gladstone Institutes San Francisco, United States Full timeDescription · : The laboratory of Christina Theodoris, MD, PhD, is seeking a talented and motivated research associate (I, II, III or Sr.) with background in experimental genomics to join her research program in the Gladstone Institute of Cardiovascular Disease and Gladstone Ins ...
-
Research Associate
2 weeks ago
Keywords Studios San Francisco, United States ContractWork Location: USA Remote (California, Idaho, Nevada, Oregon, or Washington) · Work Hours: M - F, 9:00 am - 5:30 pm · Pay Rate: $22 - $27/hr DOE and location · The Research Associate is a non-traditional role in which you will work on our data collection team. You have a backg ...
-
Research Associate
2 weeks ago
Gladstone Institutes San Francisco, United States Full timeDescription · : Your will focus on mapping protein interactions and perturbations in signaling networks upon virus infection. This role is an excellent opportunity to learn a number of valuable, cutting-edge techniques in cell biology and proteomics while working with a dynamic ...
-
Research Associate
2 weeks ago
R&D Partners San Francisco, United StatesR&D Partners is seeking to hire a Research Associate I in South San Francisco, CA. Your main responsibilities as a Research Associate I: Recording scientific observations during gross examinations Excising, weighing, and fixating tissues during necro Research Associate, Associate ...
-
Research Associate
3 weeks ago
Heluna Health San Francisco, United StatesHeluna Health invites applications for a Research Associate position in the Center for Public Health Research (CPHR) at the San Francisco Department of Public Health. CPHR is a research unit that engages in a wide range of public health research including studies of populations a ...
-
Research Associate
2 weeks ago
BioSpace San Francisco, United StatesJob Details · Category:Science · Lab/Area:Theodoris Lab · Description: · The laboratory of Christina Theodoris, MD, PhD, is seeking a talented and motivated research associate (I, II, III or Sr.) with background in experimental genomics to join her research program in the Gladsto ...
-
Research Associate
1 day ago
Gladstone Institutes San Francisco, United States Full timeCategory:Science · Lab/Area:Bruneau LabDescription: · Research Associate – Bruneau Lab · Who we are: · The Gladstone Institutes is an independent, not-for-profit research institution. Its mission is to improve the health and well-being of all people through medical research and e ...
-
Research Associate
2 weeks ago
BioSpace San Francisco, United StatesJob Details · Category:Science · Lab/Area:Bruneau Lab · Description: · Research Associate - Bruneau Lab · Who we are: · The Gladstone Institutes is an independent, not-for-profit research institution. Its mission is to improve the health and well-being of all people through medic ...
-
Research Associate
2 weeks ago
The Chan Zuckerberg Biohub, Inc. San Francisco, United StatesThe Opportunity · The · Balla · group is building an interdisciplinary team of researchers with experience in molecular biology, microscopy, virology, and immunology, to study virus infection using zebrafish as a model system. As part of this effort, we are looking for an ener ...
-
Research Associate
3 weeks ago
Heluna Health San Francisco, United StatesHeluna Health invites applications for the full-time position of Research Associate in the Center on Substance Use and Health (CSUH) at the San Francisco Department of Public Health. · CSUH conducts pharmacologic and behavioral interventions, observational studies, and related ac ...
-
Research Associate
2 weeks ago
Federal Reserve System San Francisco, United States**Company** · Federal Reserve Bank of San Francisco · We are the Federal Reserve Bank of San Francisco-public servants with a mission to advance the nation's monetary, financial, and payment systems to build a stronger economy for all Americans. We are a community-engaged bank, a ...
-
Research Associate
2 weeks ago
Heluna Health San Francisco, United StatesHeluna Health invites applications for a Research Associate position in the Center for Public Health Research (CPHR) at the San Francisco Department of Public Health. CPHR is a research unit that engages in a wide range of public health research including studies of populations a ...
-
Research Associate
2 weeks ago
BioSpace San Francisco, United StatesJob Details · Category:Science · Lab/Area:Pelka Lab · Description: · We are recruiting a Research Associate (RA) to assist with our efforts to systematically dissect multicellular interaction networks in human tumors to improve immunotherapy. Our lab is part of the joint Gladston ...
-
Research Associate
4 weeks ago
Gladstone Institutes San Francisco, United States Full timeCategory: · Science · Lab/Area: · Pelka Lab · Description: · We are recruiting a Research Associate (RA) to assist with our efforts to systematically dissect multicellular interaction networks in human tumors to improve immunotherapy. Our lab is part of the joint Gladstone-UCSF I ...
-
Research Associate
3 weeks ago
BioSpace San Francisco, United StatesJob Details · Category:Science · Lab/Area:Marson Lab · Description: · Who we are: · The Gladstone Institutes is an independent, not-for-profit research institution. Its mission is to improve the health and well-being of all people through medical research and education in neurosc ...
-
Research Associate
1 week ago
Gladstone Institutes San Francisco, United States Full timeCategory: · Science · Lab/Area: · Theodoris Lab · Description: · The laboratory of Christina Theodoris, MD, PhD, is seeking a talented and motivated research associate (I, II, III or Sr.) with background in experimental genomics to join her research program in the Gladstone Insti ...
-
Research Associate
2 days ago
Planet Pharma San Francisco, United States11-month initial contract/extendableOnsite in SSF, CA- Must already be local · Description:Reporting to the Head, Analytical Development, the RA will be responsible for developing assays for the GMP release of drug substances and drug products, ddPCR, cell-based assay, gel runni ...
-
Research Associate
2 weeks ago
Vilya San Francisco, United StatesVilya is a computational biotechnology company creating a novel class of medicines to precisely target disease biology. We believe computational approaches are an integral, if not foundational, component of drug discovery and development. Our platform is built on ground-breaking ...
Clinical Research Associate - San Francisco, United States - TalentBurst
Description
Position: Clinical Research Associate with Ophthalmology ExperienceLocations: (3 days a week onsite at the site. You may have to travel to other states as well besides your own.)
Job Description:
As a Contract CRA in ophthalmology, you will be responsible for monitoring and managing clinical trials, at the sites under your responsibility, related to eye diseases, ophthalmic treatments, and ophthalmic devices. You will ensure that these trials are conducted in compliance with international guidelines, local regulations, industry standards, and study protocols. This position is regionally based and involves working with multiple clinical trial sites across multiple protocols.
Education and Experience:
1. Site Selection and Initiation: