• Study Preparation:
  • Ability to understand and follow institutional SOPs   
  • Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.   
  • Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct   
  • Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff   
  • Assist with planning and creation of appropriate recruitment and marketing materials   
  • Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc. 
  • Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies   
  • Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives   
  • Assist in the creation or review of protocol specific source documents   
  • Determine facility, equipment and outsource vendor requirements and availability   
  • Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance 
  • Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks  
• Study Management:
  • Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety. 
  • Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies  
  • Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records   
  • Collect and evaluate concomitant medications   
  • Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual. 
  • Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings   
  • Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave   
  • Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials   
  • Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access team in an ongoing fashion   
  • Maintain effective relationships with study participants and other Care Access personnel   
  • Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access personnel and management   
  • Strong and clear communication skills, both verbally and in writing   
  • Accept accountability for actions and function independently  
• Patient Coordination:
  • Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment   
  • Obtain informed consent per Care Access SOP and document process when revised ICF discussed with patient during course of the trial   
  • Administer delegated study questionnaires, where appropriate.   
  • Collect and evaluate medical records with the support of medically qualified members of the study team. 
  • Complete visit procedures and ensure proper specimen collection, processing and shipment in accordance with protocol   
  • Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.   
  • Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion   
  • Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs) 
  • Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol  
  • Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround   
  • Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance.   
  • Monitor patient progress on study medication   
• Documentation:
  • Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP  
  • Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion.   
  • Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart   
  • Accurately transcribe data to CRF or EDC.  
  • Resolve data management queries and correct source data as needed  
  • Record protocol exemptions and deviations as appropriate with sponsor.  
  • Complete Note(s)-to-File for patient chart and regulatory filing if necessary   
  • Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing   
  • Maintain copies of patient-specific correspondence in source charts   
  • Assist regulatory personnel with completion of continuing/final review reports   
• Perform other duties as assigned.  

• Bilingual proficiency required: Must be fluent in both English and Spanish, with the ability to effectively communicate (written and verbal) in both languages.
• Excellent working knowledge of clinical trials, medicine and research terminology   
• Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+   
• Ability to communicate and work effectively with a diverse team of professionals   
• Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail  
• Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word, and excel. 
• Proficiency with technology used to support the clinical trial industry.  CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc. 
• Critical thinker and problem solver   
• Friendly, outgoing personality; maintain a positive attitude under pressure   
• High level of self-motivation and energy   
• Excellent professional writing and communication skills   
• Ability to work independently in a fast-paced environment with minimal supervision  

Certifications/Licenses, Education, and Experience:

• BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred   
• RN or LPN preferred   
• Research Professional Certification- CRCC or exam eligibility preferred  
• A minimum of 3 to 4 years Clinical Research experience   
• A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred.   

The expected salary range for this role is $70,000 - $100,000 USD per year for full time team members.

Benefits & Perks (US Full Time Employees)

• Paid Time Off (PTO) and Company Paid Holidays
• 100% Employer paid medical, dental, and vision insurance plan options
• Health Savings Account and Flexible Spending Accounts
• Bi-weekly HSA employer contribution
• Company paid Short-Term Disability and Long-Term Disability
• 401(k) Retirement Plan, with Company Match