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Job Description | Clinical Research Coordinator
Title | Clinical Research Coordinator
Location | Open
Department | Clinical Operations
Reports To | Director of Clinical Operations
Overview
The Clinical Research Coordinator (CRC) is responsible for activities associated with planning, initiating, coordinating, and implementing clinical trials within the SOFIE FAPI program under the direction of the Director of Clinical Operations. The CRC will maintain the Electronic Data Capture (EDC) system and serve as a liaison between SOFIE, clinical trial sites, and vendors. The CRC will also manage and support sites to reconcile study queries, address site issues, and generate reports as needed.
Essential Duties and Responsibilities
▪ Provides study management, support, and coordination for FDA-regulated clinical research trials under the supervision of the Director of Clinical Operations.
▪ Perform data management activities on the EDC system and generate reports as necessary.
▪ Serve as a liaison with vendors, including tissue analysis support, image analysis, data management and laboratory services, and clinical personnel as necessary.
▪ Responds to correspondence, queries, and informational requests in a timely manner.
▪ Demonstrates compliance with Good Clinical Practice (GCP), Study Protocol, and any applicable healthcare and research regulations.
▪ Support sites with patient recruitment, enrollment, scheduling, and consent efforts.
▪ Ensure timely response to adverse events and any deviations per SOFIE guidelines.
▪ Responsible for completion of necessary documents for IRB or FDA in a timely manner.
▪ Work closely with the Regulatory lead to ensure appropriate data and documents are in place in support of regulatory filings.
▪ Perform additional duties and responsibilities as requested by Director of Clinical Operations or Chief Scientific Officer.
▪ The candidate is expected to travel 10% of time.
Qualifications and Requirements
▪ Bachelor’s degree or Master’s degree in Sciences or related field.
▪ Minimum 2 years' experience as Clinical Research Coordinator or relevant research experience.
▪ Certified Clinical Research Coordinator (SOCRA or ACRP) preferred
▪ Attention to detail and strong organization capabilities.
▪ Strong interpersonal communication skills.
▪ Ability to take feedback constructively and function in a team-oriented work environment.
▪ Knowledge of Good Clinical Practices and FDA regulatory guidelines regarding clinical research.
▪ Project management and coordination skills.
▪ Proficient in MS Office applications required.
▪ Ability to work independently with minimal supervision in a remote setting.
About the Company:
SOFIE
SOFIE is motivated by Innovation. Passion. Collective genius. Hard work. We believe in nurturing great ideas and great people. From our Board to our Team, we’re dedicated to bringing a new vision of theranostics and innovative technologies to healthcare.
With our acquisition of Zevacor Pharma, Inc in 2017, we have become SOFIE, a combined company of radiopharmacies, contract manufacturing services, radiosynthesizers, and pre-clinical imaging systems. We are especially excited about the possibilities before us in 2018, as we’ll be offering new products and an expanded network to support our belief in life-changing Theranostics, and continue to lead the way in quality, service, and innovation. Together, we’re on a mission to improve patient lives, from start to clinic. If you want to join us in our mission, visit our careers page and help us change the world
We offer a competitive salary, a comprehensive benefits package, and advancement opportunity. SOFIE is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or other characteristic protected by law.
Company Size:
100 to 499 employees
Industry:
Biotechnology/Pharmaceuticals
Founded:
2017
Website:
https://sofie.com/
Full Time
Scientific Services
$106k-138k (estimate)
02/10/2024
05/04/2024
sofie.com
LOS ANGELES, CA
200 - 500
2008
Private
PATRICK W PHELPS
$200M - $500M
Scientific Services
SOFIE is a provider of theranostic treatment for patients in order to prevent them from life-threatening diseases.
The job skills required for Clinical Research Coordinator include Clinical Research, Clinical Trial, Analysis, Coordination, Planning, Scheduling, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Research Coordinator. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Research Coordinator. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical Research Coordinator positions, which can be used as a reference in future career path planning. As a Clinical Research Coordinator, it can be promoted into senior positions as a Clinical Research Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Research Coordinator. You can explore the career advancement for a Clinical Research Coordinator below and select your interested title to get hiring information.