Lead Clinical Research Coordinator

The primary responsibility of the research coordinator is to manage all logistical aspects of conducting clinical trials. The research coordinator is required to have an in-depth knowledge of protocol requirements and good clinical practice set forth by federal regulations. Qualifications/Skills The following, or equivalents, are the minimum requirements to perform the essential functions of this position. Associate's Degree preferred or equivalent education and experience Minimum of 2 - 3 years of experience in clinical trials is required Professional level experience in planning, organizing and process management is desired Possesses functional knowledge of GCP and ICH Guidelines Knowledge of medical and clinical research terminology Maintains knowledge of and adherence to HIPAA regulations appropriate to position Effective time management and analytical skills Excellent communication skills

MAJOR TASKS, DUTIES AND RESPONSIBILITIES

Provides protocol specific information and necessary training for physicians, primary care nurses and patients for each protocol Creates protocol specific source documents Develops the Protocol Operations Manual (POM)for each protocol Identifies, screens and enrolls subjects into clinical trials Participates in informed consent process and documents appropriately Assures patient eligibility is satisfied prior to enrollment and/or protocol therapy Coordinates protocol treatment plan and required follow-up with patient, medical staff, nursing staff, and ancillary staff personnel Schedules research related tests and appointments per protocol Performs study specific procedures within scope, as needed Processes and ships study labs to central labs, as needed Obtains pre-certifications, as required Monitors study patients to assure treatment and follow-up are conducted according to protocol and sponsor guidelines Assesses patients for response to protocol therapy including toxicity assessment and disease status Reviews laboratory data and provides to Principal Investigator/Sub-Investigator for review and signature Assesses and documents subject compliance with medications and visits Provides patient care and oversight for subjects in the active treatment and short-term follow-up phases of a study, and transitions patient care to data manager effectively for long-term follow-up to occur (including conducting phone calls, visits, or communications) Obtains investigational product assignments and distributes assignment, as needed Assures timely and accurate study drug distribution Maintains copies of all prescriptions written for study drug supplies, as appropriate Records all adverse events as outlined in protocol and provides to study physician to assess causality Reports all serious adverse events to the principal investigator, sponsor, primary care physician and IRB as outlined in the protocol Reviews safety reports and collects the study physician's signature as required by sponsor or IRB Coordinates/conducts activities with the collection, preparation and shipment of protocol related samples within specified parameters Completes time and effort analysis for budgeting purposes Obtains appropriate signatures on study documents, as needed Schedules and organizes monitoring visits Completes follow-up tasks required after monitoring visits are completed, as needed Collects, compiles and records data on case report forms according to protocol requirements for the active treatment and short-term follow-up phases of a clinical trial Addresses data queries in a timely manner, according to protocol requirements Responsible for real-time maintenance of up-to-date patient information, including treatment/follow-up status and patient event certification which drives the billing process Ensures quality data, responsible for the overall accuracy and timeliness of data submitted into sponsor's EDC system Participates as needed in ongoing quality assurance and control processes, and preparation of records for internally or externally sponsored audits and FDA audits Collaborates in the review of new/proposed protocols to substantiate the feasibility of studies and non-competing nature of new studies under consideration Participates in the operational review of a proposed clinical trial to ensure operational and technical feasibility

Job Types:

Part-time, Contract Job Types:

Part-time, Contract Pay:

From $25.00 per hour

Work Location:

In person