HOW LONG HAVE THE DUTIES & DISTRIBUTION OF TIME BEEN SUBSTANTIALLY AS BELOW? |
ATTACH A COPY OF MOST RECENT ORGANIZATION CHART | |
AMOUNT OF TIME |
DUTIES AND TASKS |
|
70% | Administration/Clinical Research |
Coordinate research studies, identify participants according the IRB approved recruitment plan and assist the PI with determining patient eligibility. | |
Facilitate the informed consent process, communicate protocol requirements to the participant, provide participant education related to protocol requirements and the significance of protocol compliance. | |
Complete, organize and maintains all documentation required by the Food and Drug Administration (FDA) Code of Federal Regulations (CFR), Good Clinical Practice (GCP) Guidelines, or the funding source. | |
Manages patient registration, data, and treatment assignment. | |
Participates in quality control and quality assurance activities related to study workflows and documentation. | |
Procure and distribute required study supplies to the appropriate sites for study start-up and ongoing study needs. Including Coordination of specimen collection, processing, & shipping biospecimens. | |
Facilitate the safe and accurate completion of protocol required procedures in accordance with FDA CFR, GCP, and institutional best practice. | |
Collect information for adverse event (AE) or serious adverse event (SAE) reporting to review with the Investigator and facilitates reporting requirements to applicable stakeholders (DSMB, IRB, funding source). | |
5% | Data & Regulatory Management |
Assist in developing the study informed consent form(s) and amending the informed consent form(s) as applicable. | |
Prepare and submit site or study-specific regulatory documents. | |
Track and maintain required case histories/ essential documents as defined by FDA CFR and GCP to ensure regulatory compliance. Assist with routine and audits performed by internal review committees and/or external stakeholders. | |
Ensure timely regulatory reporting and thorough documentation. | |
Develops and implements adequate Corrective and Preventative Action (CAPA) plans as needed. | |
10% | Training and Development |
Completes role-based training and occupational training as applicable, e.g. blood borne pathogens, infection control, hand hygiene, donning and doffing PPE. | |
Attend study initiation meetings, and participate in team and general staff training events (i.e., teleconferences, webcasts, and/or meetings). | |
Completes protocol required training as needed. | |
5% | Service Excellence |
Maintain a service centered approach for both internal and external, ensuring a high level of quality, communication, and support. | |
Provide ongoing communication to all stakeholders to ensure pertinent information is disseminated. | |
Timely response to and resolution of inquiries, both written and verbal, with the appropriate level of information for the request. | |
Manage and resolve sensitive customer service related issues (internal/external stakeholders and patients). | |
10% | Department Specific Responsibilities |
Manage all patient data within the EDC system (entry, queues, maintenance, and etc.). | |
Perform pulmonary function testing in collaboration with pulmonary function research lab technicians. | |
Work with the fund manager and purchaser on patient visit reimbursements and sponsor invoicing. | |
Maintain regulatory and patient binders (on paper and electronically). | |
Review electronic medical records to identify potential research participants. | |
Other projects as assigned by supervisor and investigator. | |
SKILLS, KNOWLEDGE AND ABILITIES | TASK REFERENCE | IMPORTANCE |
Bachelors Degree or 1-3 years of previous study coordination or clinical research coordination experience | All | Preferred |
Strong verbal and written communication skills along with strong interpersonal skills to effectively establish rapport, and build collaborative relationships. | All | Essential |
Strong organizational capabilities to organize multiple projects and competing deadlines for efficiency and cost-effectiveness. | All | Essential |
Analytical skills sufficient to work and solve address problems and identify solutions with reasoned judgment. | All | Required |
Ability to adapt to changing job demands and priorities; work flexible hours to accommodate research deadlines. | All | Required |
Ability to respond to situations in an appropriate and professional manner. | All | Required |
Ability to concentrate and focus in a work environment that contains distracting stimuli and competing deadlines. | All | Required |
Ability to be flexible in handling work delegated by more than one individual. | All | Required |
Typing and computer skill/ability including word-processing, use of spreadsheets, email, data entry. Ability to navigate numerous software programs and applications. | All | Required |
Ability to handle confidential material information with judgement and discretion. | All | Required |
Working knowledge of the clinical research regulatory framework and institutional requirements. | All | Preferred |
Mathematical skills Sufficient to prepare clinical research budgets, knowledge of math ability and knowledge of clinical trials research budgeting process to assist with the preparation of clinical trial budgets. | All | Preferred |
Working knowledge of FDA Code of Federal Regulations (CFR) and ICH Good Clinical Practice (GC) for clinical research. | All | Preferred |
Be available to work in more than one environment, travel to meetings, off-site visits, conferences, etc. | All | Preferred |
Fluent in writing and speaking Spanish. | All | Preferred |
Demonstrated skills in using PC computer, MS Word, MS Excel, PowerPoint, Internet and Windows applications. | All | Preferred |