Join the MDMRI Team!
Become a part of a world-class clinical research center of excellence!
OPEN POSITIONS INCLUDE:
Clinical Research Data Entry Coordinator/Regulatory-QI/QA Support
Miami Dade Medical Research Institute is a multi-specialty research dedicated facility. This position is responsible for the accurate entry of clinical trial data found on paper based source documents into sponsor Electronic Data Capture (EDC) system. This position requires exceptional attention to detail and the ability to follow study specific procedures and adherence to data management compliance. The position works closely with the research coordinators in support of all ongoing clinical studies. The clinical research data entry coordinator will also be responsible for resolving all data queries. This position will also require the ability to work independently on multiple research projects and requires daily interaction with research team members, physicians and other health care professionals as well as sponsors and other individuals that are integral to the completion of a research project. Duties may also include peer-to-peer quality review to ensure data integrity and contributions to process improvements. EDUCATION AND EXPERIENCE: •University Bachelor’s degree in a health-related field. •Minimum of 3 years of data management experience in lieu of degree •Clinical research experience, health related field or QI/QA •Fluent in English and Spanish required KNOWLEDGE AND SKILLS: •Working knowledge of clinical research Electronic Data Capture (EDC) systems. •Excellent interpersonal skills to deal effectively with research personnel. •Knowledge of medical terminology. •Knowledge of ICH GCP, FDA, OHRP, OSHA and HIPAA guidelines pertaining to clinical research. •Computer proficiency and proficient in MS Office •Accuracy in typing / data loading. •Excellent organizational skills to independently manage work flow. •Ability to prioritize quickly and appropriately with minimal guidance. •Ability to multi-task. •Ability to work independently and function as part of a team. •Ability to react calmly in emergent situations. •Clear and concise verbal and written communications. PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS: •Oversees and manages the data entry from the source document to the electronic case report form. •Works with the clinical research coordinators to design and or revise the data collection forms and standard communication documents as needed. •Works with the clinical research coordinators to help identify and document areas for clarification and improvement. •Works with clinical research coordinators to clarify inconsistencies with the data to ensure integrity and quality of research data. •Assists clinical research coordinators in preparation of scheduled monitoring visits. •Assists clinical research coordinators with research database audits. •Adherence to timely data entry as required per clinical study. •Accuracy in data entry. •Verifies and corrects data as needed. •Timely resolution of data queries. •Ability to maintain a positive attitude with the research team. •Maintain professional demeanor with sponsors, monitors and auditors. •Remains current with all required trainings. •Complies with all applicable regulations, guidelines and procedures pertaining to clinical research data management •Other related duties as needed. REPORTS TO:Chief Executive Officer
Clinical Research Laboratory Coordinator
Miami Dade Medical Research Institute is a multi-specialty research dedicated facility. Under the direction and supervision of the site’s medical staff, this position is responsible for performing phlebotomy procedures in the conduct of clinical trials with emphasis on the safety and welfare of study participants. Perform the practical activities of clinical studies according to protocol, regulatory requirements, and site operating procedures. The position works closely with the PI and research coordinators in support of all ongoing clinical studies. EDUCATION AND EXPERIENCE: Medical Assistant certificate required •Phlebotomy certificate required •Three to five years of experience performing phlebotomy KNOWLEDGE AND SKILLS: •Phlebotomy skills. English and Spanish required •Excellent interpersonal skills to deal effectively with clinicians, subjects and administrators. •Knowledge of medical terminology. •Knowledge of ICH GCP, FDA, OHRP, OSHA and HIPAA, IATA guidelines pertaining to clinical research. •Excellent organizational skills to independently manage work flow. •Ability to prioritize quickly and appropriately with minimal guidance. •Ability to multi-task. •Ability to work independently and function as part of a team. •Ability to react calmly in emergent situations. •Clear and concise verbal and written communications. PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS: •Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. •Verifies positive patient identification to ensure subject safety. •Assesses subject reactions to specimen procurement. •Performs venipuncture, capillary, and/or IV specimens from study subjects according to established protocol, maintaining aseptic technique. •Obtains additional assistance when deemed necessary. •Obtains specimens according to priority and scheduled draw times. •Ensuring completion of specimen collection functions according to protocol. •Ensures that specimens are properly labeled and suitable for testing. •Ensures collection and appropriate chain of custody for all samples obtained. •Provides necessary instructions to research participants. •Remains current with all required trainings. •Complies with all applicable regulations, guidelines and procedures pertaining to phlebotomy and clinical research.
Principal and Sub-Investigators
Miami Dade Medical Research Institute seeks US Licensed doctors in medicine (MD), or Osteopathic Medicine (DO) to join our network of Principal and Sub investigators for our clinical research program. • Experience in clinical research not required. • Contract/part-time. • Flexibility in scheduling. All applicants MUST be licensed to practice medicine in the State of Florida. No substitute licenses will be considered. Specialties in Neurology, internal medicine, psychiatry, gastro, pulmonology, dermatology, urology, primary care, are welcomed. Please send your CV to Dr. Onelia Fajardo-Garcia, CEO at firstname.lastname@example.org
“We continue to expand our participation in clinical trials. We attribute our growth and success to our continuing commitment to excellence. We are committed to providing outstanding clinical research services and treating every research volunteer with dignity and respect.”
– Onelia Fajardo-Garcia, Dr. B.A., M.H.P., CRA,
Chief Executive Officer & Founder