Clinical Research Coordinator jobs in Gaithersburg, MD

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/