- Trial Master Files: Primary point of contact: set up, manage, and oversee Trial Master Files. This includes, but not limited to creation of EDLs, filing of clinical documentation and reports reconciliation and quality review to ensure accuracy, inspection readiness and regulatory compliance. This involves working with multiple functional groups.
- Provide general administrative support to the Clinical Operations Department and Study Manager(s) as needed.
- Contact clinical sites or CROs for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc.)
- Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation; coordinates updates to distribution lists for sites, CROs, vendors
- Create and maintain study trackers (e.g. Patient trackers, Form FDA 1572 tracker);
- Manage study team meetings which includes but is not limited to scheduling, preparing meeting agendas and minutes, and archiving. Coordinate logistics and materials of formal meetings as needed (e.g. data review meetings and centralized investigator meetings);
- Coordinate and manage study communications including newsletters and study updates.
- Manage Docu-sign for the team (includes formatting and QC of the documents);
- Manage and maintain listings.
- Oversee Team training: roll out, maintenance, follow up.
- Provide assistance on conference prep, materials, advertisement support, site polls, etc.
- Support study start-up activities, including site number assignment; regulatory packer review.
- Manage system access for CROs, vendors and team members.
- Maintain systems to track study metrics and general study information.
- Attend study, project and departmental meetings as required.
- Bachelor's degree with at least 2 years related experience in the industry.
- Working knowledge of GCPs, Trial Master Files, ICH guidelines, experience working in a regulated environment preferred.
- Professional demeanor and ability to work as a team member.
- Experience with MS Office Suite (Outlook, Word, PowerPoint, Excel, Project);
- Ability to coordinate and prioritize multiple tasks.
- Good problem-solving skills.
- Attention to detail, and documentation.
- Good written and verbal skills in English.
- Ability to travel (less than 10%)
- Biotechnology
- Full-time
-
clinical trial associate
1 week ago
Cargo Therapeutics San Carlos, CA, United States· Reporting to the VP, Clinical Operations, CARGO is seeking a Clinical Trial Associate to play a crucial part in the Study Management Team. The successful candidate will coordinate various administrative aspects of the sponsor's project management and oversight activities. The ...
-
Clinical Trial Associate
1 week ago
Cargo Therapeutics San Carlos, United StatesJob Description · Job DescriptionReporting to the VP, Clinical Operations, CARGO is seeking a Clinical Trial Associate to play a crucial part in the Study Management Team. The successful candidate will coordinate various administrative aspects of the sponsor's project management ...
-
Sr. Clinical Trials Associate
5 days ago
Longevitylist Redwood City, United StatesThe Senior Clinical Trials Associate (CTA) is an integral member of the Clinical Development Operations team, leading the planning, implementation and management of early and late phase clinical research studies. The CTA of Clinical Operations is responsible for creating and mana ...
-
Clinical Trial Management Associate
2 weeks ago
Revolution Medicines, Inc. Redwood City, CA, United StatesRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS p ...
-
Clinical Trial Associate
1 week ago
Glooko Palo Alto, CA, United StatesReport: This position reports to the Director, Clinical Research and Evidence Generation. · Job Summary: · The Clinical Trial Associate (CTA) plays a key role in supporting Glooko's Clinical Research projects. This role will be a good fit for candidates who desire to learn and ...
-
BioSpace Menlo Park, United StatesJob Details · Who We Are: · ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode's proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables ...
-
Clinical Trial Associate
2 weeks ago
Kelly Services, Inc. Santa Clara, United StatesKelly Science & Clinical is seeking a Clinical Trial Associate for a part time, contract position with a Medical Device start-up in Santa Clara, CA. If youre passionate about bringing the latest scientific discoveries to life and are ready to take Clinical, Associate, Clinical Re ...
-
Clinical Trial Associate
1 week ago
Calsoft Labs Natick, United States6 week assignment · bill rate 40$ · 1 day a week onsite in Natick MA · Responsibilities : · Trial Preparation and Coordination : Assist in the preparation and maintenance of essential trial documents. Coordinate/schedule meetings related to clinical trial act ...
-
Associate Trial Attorney
1 week ago
Farmers Insurance Group Oakland, United StatesWe are Farmers · We are... more than just your favorite commercials. At Farmers, we strive to deliver peace of mind to our customers by providing protection and comprehensive advice and delivering in the moments of truth. That means having people who can help us meet changing cus ...
-
ReCode Therapeutics Menlo Park, United States FreelanceWho We Are: · ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode's proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise ...
-
Clinical Trial Associate II
1 week ago
Bayside Solutions, Inc. South San Francisco, United StatesBayside Solutions is seeking a Clinical Trial Associate II to be part of our client' s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 Clinical, Associate, Support, ...
-
Sr. Clinical Trial Associate
1 week ago
Structure Therapeutics Inc South San Francisco, United StatesStructure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data i ...
-
Sr. Clinical Trial Associate
1 week ago
Structure Therapeutics Inc South San Francisco, United StatesStructure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data i ...
-
Clinical Trial Management Associate
1 week ago
Arsenal Bio South San Francisco, United StatesWHO WE ARE · Arsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented and experienced Clinical Trial Management Associate to work hybrid or remotely based in our South San ...
-
Clinical Trial Management Associate
2 weeks ago
Arsenal Biosciences South San Francisco, United StatesWHO WE AREArsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented and experienced Clinical Trial Management Associate to work hybrid or remotely based in our South San Fra ...
-
Clinical Trial Management Associate
1 week ago
Akero Therapeutics San Francisco, United StatesCOMPANY BACKGROUND · Akero Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efrux ...
-
Clinical Trial Management Associate
5 days ago
Arsenal Biosciences South San Francisco, United StatesWHO WE AREArsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented and experienced Clinical Trial Management Associate to work hybrid or remotely based in our South San Fra ...
-
Sr. Clinical Trial Associate
1 week ago
4D Molecular Therapeutics Inc. Emeryville, United StatesGENERAL SUMMARY: · 4DMT seeks a motivated and experienced Senior Clinical Trial Associate to support the Company's clinical trial activities. This position reports to the CTM/Sr. CTM, Clinical Operations and will be responsible for supporting the day-to-day operations of one or m ...
-
Sr. Clinical Trial Associate
1 week ago
Structure Therapeutics Inc South San Francisco, United StatesStructure Therapeutics develops life?changing medicines for patients using advanced structure?based and computational drug discovery technology. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data i ...
-
Clinical Trial Manager Associate
1 week ago
Vera Therapeutics Inc. Brisbane, United StatesTitle: Clinical Trial Manager Associate · Location: Brisbane, CA · About Us: · Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the sour ...
Clinical Trial Associate - Redwood City, United States - Biomea Fusion Inc.
Description
Position Summary:
The Clinical Trial Associate/Sr.
Clinical Trial Associate role will provide administrative and operational support for Biomea sponsored clinical trials which includes but is not limited to managing Trial Master Files, providing support to clinical trial start up, maintenance and close out activities, tracking of all study documentation, providing coordination of other functional activities that relate to the conduct of clinical trials.
This is an onsite role in Redwood City, CA.Responsibilities:
Education and Experience Requirements:
Industry:
Employment Type:
Equal Employment Opportunity:
At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients.
As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
The anticipated salary range for qualified candidates for this role is $80,000 to $105,000.An individual's position within the range is influenced by multiple factors, including education, relevant work experience, tenure, and market dynamics.
These factors will determine the actual salary offered.In addition to the competitive base salary, we all offer a performance-based discretionary bonus program, equity awards and comprehensive benefits program.
