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United Urology Group · 4 hours ago

Research Coordinator

Towson, MD

Full-time

Onsite

Entry, Mid Level

$27/hr - $31/hr

2+ years exp

United Urology Group is dedicated to providing exceptional urologic care and fostering a supportive work environment for its employees. The Research Coordinator will be responsible for managing clinical trials, ensuring protocol compliance, enrolling study subjects, and maintaining accurate documentation throughout the research process.

Health CareHealth DiagnosticsOncologyWellness

Responsibilities

Conducting Clinical Trials

Review with the Principal Investigator (PI) the inclusion/exclusion criteria, overall structure, and requirements of each protocol and ensure logistics for site implementation

Review the protocol and the informed consent form for accuracy and clarity

Develop and implement strategies for subject recruitment and ongoing communications with all physicians, research staff, and office staff

Complete new trial feasibilities upon review with potential Investigator and submit to Sponsor/CRO. Complete and submit CDA to Sponsor/CRO in accordance with site Standard Operating Procedures (SOP)

Schedule site Sponsor visits in accordance with internal SOP

Prepare study charts, binders, and supplies for offsite storage in conjunction with the Regulatory Specialist, when applicable

Ensure maintenance and calibration of site study required equipment

Enrollment of Study Subjects

Review the study design and inclusion/exclusion criteria with the PI/SI, and if needed the Sponsor to ensure understanding

Review, verify, and record/collect all relevant documentation in the subject’s medical record needed to confirm study eligibility

Review the protocol, informed consent form, and follow-up procedures with the potential study subjects

Ensure the current approved informed consent is signed before subjects are screened and enrolled

Inform and document notification of the subject’s Primary Care Physician of trial participation if approved by the subject

Perform delegated Protocol specific tasks as assigned by Principal Investigator

Ensure that the randomization procedures are followed and documented per protocol guidelines

Document protocol exemptions and deviations, as appropriate. Ensure duplication of each for filing in the subject source and with the regulatory specialist

Ensure all procedures and documentation of subject participation are kept in accordance with FDA regulations, ICH guidance, and internal SOP

Follow-Up Procedures

Schedule subjects for follow-up visits, collect subjects’ responses to therapy, and interview subjects for adverse events and changes to concomitant medications. Ensuring that a review of EMR is made during the subject visit for any notable medical/medication changes from the last research visit

Review laboratory data and communicate abnormal values to the PI/SI and as needed, primary care provider or specialist if additional medical attention is needed

Assess and document subject compliance and accountability with Investigational Product (IP). Document re-education when appropriate

Communicate with research staff to ensure timely and accurate study drug distribution when applicable

Administer study drug therapy as needed and maintain the study drug dispensing log if a pharmacist is not involved

Perform venipuncture and collect specimen collection

Record all Adverse Events outlined in protocol and review them with the PI/SI

Report all Serious Adverse Events to the principal investigator, sponsor, and IRB as outlined in the protocol and site SOP. If need be, contact the subject’s primary care physician or specialist

Administrative/Clerical

Reporting all Deviations/Adverse/SAE within Sponsor/IRB’s timeframe and in accordance with site SOP

Follow SOPs/GCPs/HIPPA according to the site, sponsor, ICH, and FDA

Maintenance of accurate and complete documentation, including but not limited to signed informed consent forms, source documentation, drug dispensing logs, subject logs, and study-related communications

Follow up and document outstanding action items on Monitoring reports, ensure PI/SI oversight, and that the site Regulatory Specialist receives reviewed/corrected/signed copy of the report

File appropriate regulatory or Sponsor communications with the site Regulatory Specialist

Create and maintain Master Subject Log and Visit Log

Qualification

Clinical research experienceCertification (CCRC/IATA/CPR/NIH/CITI)FDA clinical trial phasesGCP (ICH)Medical terminology knowledgeResearch-related terminology knowledgeCustomer service skillsComputer software skillsTyping speed (40 wpm)Attention to detailCommunication skills