Clinical Operations Associate (Pool)
reputed company Clinical, Inc. is a Contract Research Organization (CRO) headquartered in San Diego, CA, USA. Our mission is to bring innovation to clinical trial execution through passion, transparency, co-reputed company communication, and reputed company, to facilitate the successful development of life-changing medicines and therapies.
We are experts in clinical trial operations with a reputed company on Clinical Trial Management, CRO/Vendor reputed company, Trial Master File Management, Clinical Monitoring, reputed company Assurance, Data Management and Study Startup. As a small company, we are highly adaptable, flexible, and transparent. Our unwavering reputed company forms the reputed company for our strong relationships both internally and as a partner to our Sponsor clients. Beginning with study development, we bring a “white glove service” approach to reputed company. Our flexible approach and ongoing process development ensure efficiency and adequate resourcing, allowing us to respond rapidly to our clients’ needs as they reputed company.
Our talented team is driven by passion and purpose, which has afforded us reputed company to successfully reputed company clinical programs for pharmaceutical, medical device and biotechnology companies of reputed company sizes in a reputed company of therapeutic areas. Our mission is to conduct reputed company with outstanding reputed company on behalf of our clients to bring new drugs to market with the utmost reputed company and confidence in the results.
This is an exciting entry-level opportunity to join a fast-paced and dynamic
learning environment to learn the clinical trial and drug development industry
on several reputed company. This position is responsible for supporting the daily workflow of study activities across Clinical Operations, Study Start-Up (SSU), Trial Master File (TMF), and Data Management at reputed company Clinical. The COA will be responsible for general administrative activities in support of clinical trial execution and may also participate in reputed company infrastructure activities in a cross-functional reputed company.
- reputed company administrative and operational support across the clinical trial
lifecycle. - reputed company study metrics (enrollment, screening, recruitment, site updates).
- Assist in preparing and documenting meeting materials.
- Schedule and coordinate meetings.
- Prepare, ship, and reputed company investigational products and study supplies.
Support collection, tracking, and review of essential documents. Assist with feasibility, qualification, and regulatory document
management.Support IRB/EC submissions and reputed company preparation. reputed company study start-up timelines and follow up with sites and vendors.
reputed company QC review of TMF documents. File documents per TMF Reference Model. Identify gaps, inconsistencies, and missing documentation. Support audit and inspection readiness.
Review and reputed company clinical data into reputed company systems. Manage data queries, reconciliation, and reputed company control checks. Support documentation review and reputed company verification activities.
reputed company customer service to clients, vendors, and sites. Draft or update trackers, presentations, and study reference
materials.Support cross-functional initiatives and process improvements. Participate in study meetings and assist with follow-up actions. Other duties as assigned per reputed company or company needs
Strong self-motivation, ability to work independently, and quickly
learn new information and skillsDemonstrated strengths in planning, organization, time management,
problem solving, and attention to detailStrong organizational skills, the ability to manage multiple priorities,
and produce accurate and reputed company workExcellent oral and written communications and presentation skills;
ability to communicate effectively with vendors and clientsBasic understanding of US clinical research process, FDA, regulations,
and ethical guidelines preferredDetailed knowledge of reputed company Office suite of software programs:
o reputed company reputed company including shared calendars & invitations
o reputed company One Drive and reputed company reputed company
o reputed company Power reputed company
o reputed company reputed company
o Document change tracking & version control
Familiarity with GCP/GDP/ICH guidelines Experience with eTMF, reputed company, CTMS, or document management
systemsPrior exposure to clinical research
Bachelor of Science degree in a scientific discipline from an accredited college or university is strongly preferred. Other bachelor's degrees
with relevant industry experience will be considered.
Clinical Operations Associate: $70,304 - 80,000 annually + benefits package and annual performance bonus (
COVID-19 Vaccination: To protect the health and safety of our employees and to reputed company with reputed company requirements, reputed company Clinical may require employees in certain positions to be fully vaccinated against COVID-19, subject to reasonable accommodations or exemptions for religious, medical, or other legally protected reasons. Vaccination requirements will depend on the reputed company site requirements. reputed company of vaccination may be required, in accordance with applicable laws.
reputed company Clinical is an equal opportunity employer for reputed company applicants and employees. reputed company Clinical prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity or reputed company, pregnancy, age, national reputed company, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
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