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).

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.

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.

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).

Department Specific Responsibilities

Manage all patient data within the EDC system (entry, queues, maintenance, and etc.)

Work with the fund manager and purchaser on patient visit reimbursements and sponsor invoicing.

Maintain regulatory and patient binders (on paper and electronically)

Obtain medical and treatment records from outside sources as necessary.

Other projects as assigned by supervisor and investigator.

SKILLS, KNOWLEDGE AND ABILITIES

Bachelors Degree or 1-3 years of previous study coordination or clinical research coordination experience

Strong verbal and written communication skills along with strong interpersonal skills to effectively establish rapport, and build collaborative relationships.

Strong organizational capabilities to organize multiple projects and competing deadlines for efficiency and cost-effectiveness.

Analytical skills sufficient to work and solve address problems and identify solutions with reasoned judgment.

Ability to adapt to changing job demands and priorities; work flexible hours to accommodate research deadlines.

Ability to respond to situations in an appropriate and professional manner.

Ability to concentrate and focus in a work environment that contains distracting stimuli and competing deadlines.

Ability to be flexible in handling work delegated by more than one individual.

Typing and computer skill/ability including word-processing, use of spreadsheets, email, data entry. Ability to navigate numerous software programs and applications.

Ability to handle confidential material information with judgement and discretion.

Working knowledge of the clinical research regulatory framework and institutional requirements.

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.

Working knowledge of FDA Code of Federal Regulations (CFR) and ICH Good Clinical Practice (GC) for clinical research.

Be available to work in more than one environment, travel to meetings, off-site visits, conferences, etc.

Fluent in writing and speaking Spanish.

Demonstrated skills in using PC computer, MS Word, MS Excel, PowerPoint, Internet and Windows applications