Senior Clinical Research Associate (Home Based)
Location: Los Angeles, California US
Job Id: 1901
Position Title: Senior Clinical Research Associate
Precision for Medicine, Oncology & Rare Disease is a precision medicine CRO. Our uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.
Are you passionate about the challenges facing the research and development of novel compounds in rare and orphan diseases? Do you take a consultative approach to site management, proving to be a valuable partner to investigational sites?
You will be responsible for monitoring and running the progress of clinical studies at investigative sites; and ensuring that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable standards.
Are you based outside of the Los Angeles area? Not to worry, this opportunity is available for anyone based on the West Coast.
Who are we?
We are a team of clinical trial experts who dedicated to the success of our clients, so that ultimately patients can receive much-needed treatments. We believe the success of a company is much more about what it does every single day and how it does it, than about its revenues. We foster a culture where patients’ needs and the needs of our valued clients come first, where the quality of our work is the best, and where our employees can thrive, while still having fun and giving back to the patient community. We are very proud of the team at Agility and what it has achieved thus far.
- You are calm, thoughtful, and responsive when things don’t go as planned.
- You are well-prepared, whether it be for an investigator meeting, site visit or project team update, always staying two steps ahead of the game.
- You find quick and clever ways of overcoming difficulties.
- You have developed toolkits, keeping projects in order so that the information is readily available and accessible.
- You have an impeccable eye for detail.
- You identify potential study risks and know when to raise pathways.
- You are adept at handling conflict by using known resolution strategies.
What you can expect day to day:
- Independent and proactive coordination of all necessary activities required to set up and monitor a study (i.e., identify investigators; help prepare regulatory submissions, conduct pre-study and initiation visits, etc.).
- Maintain ongoing contact with assigned study sites.
- Identify, select, initiate and close out appropriate investigational sites for clinical studies. Monitor sites in order to ensure that studies are carried out according to the study protocol, Agility SOPs, applicable regulations, and the principles of ICH-GCP.
- Completes monitoring visit reports and follow up letters to document tasks completed during monitoring visits and any action items that may require additional follow-up.
- Review Informed Consent Forms (ICFs) and/or data protection authorizations to ensure all required elements have been included.
- Coordinating with the site to ensure all paper and/or electronic study related documents are appropriately completed by site personnel, and study subjects when required.
- May contribute to the development and revision of clinical documents such as protocols, Informed Consent Forms, Study Manuals, Case Report Form Completion Guidelines, Monitoring Plans, SOPs, etc.
- May review and provide input into the development of draft Case Report Forms.
- May mentor and train Clinical Research Assistants and Clinical Research Associates in clinical study monitoring, relevant federal regulations, and ICH/GCP Guidelines.
- Approximately 50-70% travel overall expected, national and regional travel.
- Perform all duties in accordance with Agility Clinical SOPs, government regulations, and GCP/GDP.
- Bachelor’s degree in a clinical, scientific, or related discipline, or equivalent work experience required (RN or LPN with at least 4 years of recent field monitoring experience)
- 5 years of experience independently monitoring clinical trials for drug studies
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.
- Experience monitoring EDC trials.
- Ability to travel overnight, primarily in the U.S., 3 days per week on average.
- Excellent communication, interpersonal and organizational skills to effectively collaborate with others.
Preferred: Experience monitoring in rare and complex therapeutic areas
Division: Precision For Medicine
Business Unit: Oncology & Rare Disease
Office Based: Remote
Employment Type: Exempt
Employment Status: Regular Full-time
Work From Home Available: Yes
City: Los Angeles
Country: United States
Community / Marketing Title: Senior Clinical Research Associate (Home Based)
Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
EEO Employer Verbiage:
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2018 Precision Medicine Group, LLC
Location_formattedLocationLong: Los Angeles, California US