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