The Research Coordinator will screen, enroll, and follow study subjects for Phase I, II, III, and IV clinical trials, ensuring protocol compliance and close monitoring while the subjects are on study.   

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.   

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice. 

Qualifications: 

• Minimum High School Diploma or GED required. 

• Minimum of two (2) years of clinical research experience.     

• Maintained certification of accreditation (CCRC/IATA/CPR/NIH/CITI) required and will be verified prior to employment. 

Key Competencies: 

• Exceptional customer service skills. 

• Strong attention to detail, a willingness to learn & the ability to stay organized. 

• Ability to perform clinical assessments. 

• Strong understanding of FDA clinical trial phases I-IV.   

• Strong understanding of GCP set forth by the ICH.  

• Proficient knowledge of medical terminology. 

• Proficient knowledge of Research-related Terminology. 

• Strong communication skills, both verbal & written. 

• Proficient computer software and database skills. 

• Comfortable working in a fast-paced environment. 

• Very comfortable asking probing questions to patients, if applicable. 

• Must demonstrate a caring, compassionate, and patient attitude. 

• Maintain HIPAA compliance. 

• Multitasking and proactive problem-solving. 

• Ability to type a minimum of 40 words per minute.