Clinical Research Coordinator

Job Details

Euless, TX DALLAS, TX; Ft Worth, TX Full Time

Description

Summary

Responsibilities

A competent Clinical Research Coordinator should be able to perform various duties and responsibilities. Proper fulfillment of a Clinical Research Coordinator’s duties and responsibilities brings success to Epic Medical Research. Clinical Research Coordinators should assist in organizing and monitoring the different stages of clinical trial activity at study performance sites of Epic Medical Research, LLC. The following are other duties and responsibilities a Clinical Research Coordinator should be able to execute:

Responsibilities for Clinical Research Coordinator

• Coordinate all clinical research activities with minimal supervision
• Expected to perform all CRC Core responsibilities (as applicable):
• Ongoing review and adherence to all pertinent IRB approved protocols
• Participate in the informed consent process of research participants
• Support the safety of clinical research participants
• Coordinate protocol related research procedures, study visits, and follow-up care
• Recruit, screen and enroll research participants
• Maintain accurate study source documents
• Report adverse events as per protocol guidelines
• Report serious adverse events as per protocol, ICG/GCP guidelines
• Follow Study Manual instructions for internal SAE reporting for EPIC MEDICAL RESEARCH
• Understand and adhere to good clinical practice (GCP) and regulatory compliance
• Responsible for completing and maintaining Delegation of Authority Log
• Responsible for ensuring that all Essential Documents and pertinent study correspondence is sent to Regulatory for filing
• Educate subjects and their family on protocol, study intervention, study drug, etc.
• Comply with Institutional policies, standard operating procedures (SOPs) and guidelines, and applicable clinical practice (Epic Medical Research Sites) guidelines
• Must comply with federal, state, and sponsor policies
  
  

Manage and/or complete essential regulatory documents

• Ensure case report forms are being completed (paper & electronic data capture) and review them against patient’s medical record for completeness and accuracy
• Ensures source documents are completed in entirety prior to completion of study visit
• Ensure EDC entry done within timeline outlined in EPIC MEDICAL RESEARCH manual
• Resolve queries within 24 hours of issuance
• May be responsible for submitting documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer)
• Facilitate pre-study, site qualification, study initiation, study close out, and interim monitoring visits
• Respond to all monitor findings during monitoring visit
• Check EClinPro system daily for your trial for updated ICFs and source documents
• Coordinate and/or participate in research/project team meetings
• Collect, process and ship laboratory specimens
• Schedule study visits and procedures
• Retain records/archive documents after study close out
• Attend weekly team meetings and other scheduled meetings as necessary
• Update Site Manager with study information for weekly QAPI meetings
• Completing New Employee Proficiency checklists within first 30 days of hire
• Responsible for maintaining and filing of all required training and certifications, if applicable*
• Perform study specific protocol procedures such as performing vital signs, EKGs, IP administration, collecting lab samples, etc., based on training and delegated responsibility
• Perform paper/e-diary training with patients as applicable
• Perform paper/e-diary review as applicable
• Review and timely response to interim monitoring reports and findings
• Checking visit summaries in EClinPro daily to ensure there are no pending visits at End of Business (EOB) Performing other EClinPro tasks as mandated within Epic Medical Research Study Manual, such as adding SAE elements necessary to ensure timely billing of invoiceable items
• Check study supplies weekly (labs, diaries, ancillary supplies) for reorder
• Completing daily clinic temperature logs,
• Verifying accuracy and documentation of temp tale readings
• Assess possible excursions and troubleshoot discrepancies and/or excursions that occur.
• Completing and documenting daily phone calls to patients
• Timely filing of patient labs, e-diary printouts, EKG, and all other study records in chart (after PI signature)
• Proactively seek ongoing training for professional development
• Preparing for or participating in QA audits conducted by EPIC MEDICAL RESEARCH, study sponsors, federal agents, or specially designated review groups
• May require travel to additional sites to cover staffing needs when necessary and determined by leadership
• May require evening and/or weekend coverage (PRN) depending on study needs
• Maintaining a safe, clutter-free and organized work environment
• Works to support a work environment aligned with EPIC MEDICAL RESEARCHs mission and values
• Respond to email communications within 48 hours
• Needs to demonstrate consistent professional conduct, communication and meticulous attention to detail
• Must possess excellent verbal and written communication skills as well as excellent interpersonal skills with patients, staff, and other health care professionals.
• Ask questions when unsure of the answer
• And other duties as assigned
  
  

Qualifications

Qualifications

Clinical Research Coordinator Skills And Qualifications

• Strong written and oral communication skills
• Ability to build effective relationships with trial center colleagues and staff
• Superior problem solving, deductive reasoning and decision-making skills
• Good time management and ability to prioritize tasks and accomplish set goals efficiently
• 1 years previous experience working in a clinical setting
• Clinical knowledge – a qualified research coordinator should have some knowledge of biology, biochemistry, research techniques, psychology, and other health and science disciplines
• Understanding of safety regulations – safety regulations are immensely important, and if a company or organization does not follow them, they could be fined or face other serious consequences. Research coordinators should be aware of these regulations and how they can impact the study
• Data entry – research coordinators should know how to enter large amounts of data into a database. They may even be tasked with using software to compile reports or graphs depicting the findings of the study
• Attention to detail – research coordinators should be capable of recognizing small details, especially since they can have a major impact on the outcome of a study. They should pay attention to any feedback provided by test subjects and any irregular findings
• Communication skills – strong written and verbal communication skills are needed to become a research coordinator. Research coordinators should also feel comfortable sending emails and interacting with other coordinators and researchers
• Capable of working independently with minimal supervision and also as part of a team
• Skilled with standard computer programs including the MS Office suite
• Ability to speak a second language is an asset, but not required