Clinical Research Coordinator Position Available In Manatee, Florida

Description:

The Clinical Research Coordinator (CRC) will screen, enroll and follow study subjects while ensuring protocol, regulatory compliance and close monitoring while subjects are in study.

Our Culture:

Inspire hope. Build your legacy. Discover a rewarding, fulfilling, well-balanced career at Florida Research Institute, a division of Florida Digestive Health Specialist, LLP. With providers and locations across Florida, FDHS is one of the largest single-specialty, physician-owned GI practices in the state. FDHS was established in 2011 to provide comprehensive, high-quality gastroenterology services and foster advanced research for digestive health problems. With a growing team of nationally acclaimed care centers, providers, and staff, we continue to expand our reach to communities that need our care.

About Florida Research Institute :

Florida Research Institute (FRI) is committed to providing advanced therapies to individuals in need, with a focus on delivering exceptional patient care. Our primary research facility, situated in Lakewood Ranch, FL, is a global leader in gastroenterology and hepatology research, with a team of more than 20 highly trained clinical research experts.

Essential Duties:

Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials Obtain informed consent Complete visit procedures and ensure proper specimen collection processing and shipment in accordance with protocol Be prepared to complete basic clinical procedures, such as blood draws, vital signs, and ECGs Review laboratory results, ECGs, and other test results (e.g., MRI and Biopsy reports) for completeness and alert values, ensure investigator review in a timely fashion Recognize Adverse Events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator Schedule patients within visit windows Dispense study medication per protocol and or IVRS system Educate subject on proper administration and importance of compliance Monitor subject progress on study medication Travel to Venice and Sarasota to see subjects at other sites

Documentation:

Create source documentation Record data legibly, in real time on source documents Accurately record study medication inventory, medication dispensation, and patient compliance Accurately transcribe data to CRFs. Resolve data management queries and correct source data as needed Record protocol exemptions and deviations as appropriate with sponsor Maintain copies of patient-specific correspondence in source charts Assist regulatory personnel with completion of continuing/final review reports Other duties as assigned. Please note that the duties and responsibilities outlined in this job description are not exhaustive and may be subject to change at any time to meet the evolving needs of the company.

Qualifications:

Required 2 years of clinical research coordinator experience Eligible to take certification exam GCP training and certification Research Professional Certificate – CCRC or exam eligibility preferred. Excellent working knowledge of medical and research terminology Extensive working knowledge of federal regulations, Good Clinical Practices (GCP) Ability to communicate and work effectively with a diverse team of professionals Strong computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS Word and Excel Excellent interpersonal skills, detailed-oriented and meticulous Proficient Computer Skills Ability to work independently in a fast-paced environment with minimal supervision Physical Demands The employee is frequently required to walk; sit; use hands for fine manipulation, handle or feel and reach with hands and arms using a keyboard and video display terminal. The employee is occasionally required to stand and stoop, kneel, crouch or crawl and climb stairs. The employee should be able lift and move up to 25 lbs. The work environment is typically quiet to moderate with standard clinic, laboratory and office room noise levels.

EEO Statement:

It is the policy of Florida Digestive Health Specialists to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. When you join FDHS, you become part of a premier team striving to deliver unparalleled, personalized care while treating patients like family. And at FDHS, our patients are at the heart of everything we do. Join our team at FDHS and make a difference in the lives of our patients and employees alike!