Clinical Research Coord I

Clinical Research Coordinator I

The Department of Medicine, Division of Infectious Diseases and Global Medicine is seeking a Clinical Research Coordinator I. This position will coordinate ongoing clinical research trials within the Division of Infectious Diseases and Global Medicine under the direction of Senior Clinical Research Coordinators and the Clinical Research Manager.  As part of an interdisciplinary health team, the incumbent will collaborate with other Clinical Research Coordinators, physicians, nurses, and other key personnel in the department and clinic to ensure compliance with protocol requirements and satisfactory care for enrolled patients. The incumbent will also assist in the execution of protocol procedures and data collection.

Essential Functions;

Executes various components of the research study to ensure the outlined benchmarks are met. Reviews and comprehends the research study aims, benchmarks and timeline. Participates in communication related to study.

Completes logistics management, study data collection, storage, retrieval, and interpretation. Coordination of relevant care and protocol required testing for subjects enrolled on an assigned portfolio of human clinical trials. This will include a variety of patient focused tasks such as screening, enrolling, and coordinating related care and other relevant tasks, all of which require regular, timely communication with clinic staff, physicians, investigators, other CRO staff, and the subjects themselves, as well as minute attention to detail throughout the conduct of the trial; Daily screening of the EMR for qualifying participants; Educate subjects and family on protocol, study intervention, study drug, etc. Monitors patients’ labs to ensure on-going eligibility to receive study drugs; Conducting daily data entry, maintenance and query reports; Plan and schedule timelines and milestones using appropriate tools. Track project milestones and deliverables; Schedule subject visits and procedures; Interpretation and collection of medical and clinical data of potential and existing subjects on assigned clinical trials.  Maintaining compliance with all internal and external regulatory and institutional requirements related to your trials. You will also attend all relevant trainings and meetings including in-service education related to assigned protocols to ensure study compliance; Coordination of all sample collection, processing in a BSL-2 lab, analysis, and shipping for assigned trials. Mentoring of new staff on the above-named duties; Comply with Institutional policies, standard operating procedures (SOPs) and guidelines;
Must comply with federal, state, and sponsor policies; Understands good clinical practice (GCP) and regulatory compliance; Participates in promoting Human Subjects Protections within Clinical Research area

Assists with regulatory document preparation and review. Study specific source documentation and other materials. Study guides and worksheets.

Assists in preparing for monitor and oversight visits. Scheduling oversight committee and monitoring visits/meetings. Making sure all source documents are available.

Attends study related meetings and other specified tasks.

$40,000 - $51,510 Annually 

Associate’s degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.

Good Clinical Practice (GCP) and IATA certified
Experience using OnCore and Epic
Experience working in a clinical setting
Experience working in REDCap
Experience working in Electronic Data Capture (EDC) systems
Excellent interpersonal skills and the ability to prioritize and effectively communicate verbally and in writing.
Coordinates multiple tasks and work independently and productively in a fast paced, deadline-oriented environment.
Able to work collaboratively, forward ideas as appropriate and problem solve when needed.
Multi-media capabilities strongly preferred; proficiency with Microsoft Office such as Word, PowerPoint and Excel

In order to be considered, you must upload your resume.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.