Clinical Research Study Coordinator

CLINICAL RESEARCH STUDY COORDINATOR

REPORTS TO Site Director & Study Principal Investigator

JOB SUMMARY

The Clinical Research Coordinator (CRC) role at the Global Alzheimer's Platform Foundation (GAP) site is designed to oversee all delegated tasks involved in the execution of clinical trials, operating under the direct supervision of the Principal Investigator. The CRC is expected to possess a comprehensive understanding of protocol requirements and must execute study activities in strict accordance with Good Clinical Practice (GCP) guidelines and federal regulations. As the primary point of contact for the protocols, the research coordinator will serve as a crucial link between the investigators, primary care providers, the Institutional Review Board (IRB), and the sponsor. Working alongside the investigator, the research coordinator will be responsible for the screening, enrollment, and ongoing monitoring of study subjects, ensuring their adherence to the study protocol and maintaining rigorous oversight throughout their participation in the study.

Moreover, the coordinator assumes responsibility for all aspects related to data collection and source documentation, timely reporting of adverse events, and the meticulous maintenance of complete investigator files for the site. This multifaceted role is pivotal in ensuring the successful execution of clinical trials and the advancement of Alzheimer's research.

Duties

Study Preparation:

• Review and assess protocol (including amendments) for clarity, logistical feasibility, subject safety, and inconsistencies
• Discuss study medication, required procedures, eligibility criteria and impact on office flow with investigators and staff
• Assist with planning and creation of appropriate recruitment materials, as well as assist in development of recruitment plan and obtain listing of potential candidates to contact from database
• Actively work with recruitment team in calling and recruiting subjects
• Participate in Investigator’s Meeting (IM) and/or coordinate pre-study site visit with clinical staff and Sponsor/CRO representatives
• Create (or review sponsor- provided) protocol specific source documents
• Review and determine facility, equipment, and outsource vendor availability
• Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access, and passwords)
• Work with PI to ensure education of staff and/or sub investigators is completed for required tasks

Study Management:

• Learn to integrate new trial with existing trial load, delegate tasks as necessary, and prioritize activities regarding protocol timelines
• Maintain organized files and supplies including blank source documents and patient charts
• Work with other staff to actively handle investigational product accountability: receive, inventory, dispense, monitor patient compliance, and re-order if necessary. Document on accountability log and patient records
• Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during these meetings
• Ensure trial activities are discussed in advance with covering personnel in case of sick leave or planned time off
• Actively practice and 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 research staff in an ongoing fashion
• Develop and maintain effective relationships with study participants and their partners
• Interact in a positive, professional manner with patients, sponsor representatives, outside offices, investigators, and Global Alzheimer’s Platform Foundation (GAP) personnel
• Communicate clearly verbally and in writing
• Accept accountability for actions and learn to function independently

Patient Coordination:

• Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment
• Obtain informed consent per SOP and document process
• Be prepared to complete basic clinical procedures, such as blood draws, vital signs, and ECGs
• Work with laboratory coordinator to ensure proper specimen collection, processing, shipment, and documentation in accordance with protocol
• Schedule study visits per study protocol and ensure all required visit procedures are complete prior to the subject leaving the office
• Review laboratory results and other test results for completeness and alert values. Ensure investigator reviews in a timely fashion
• Work with mentor to recognize adverse events (AEs) and Serious Adverse Events (SAEs)
• Promptly notify Principal Investigator, sponsor, and site regulatory coordinator. Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol
• Work with administrative coordinator to schedule patients for necessary procedures and visits within appropriate windows as outlined in the protocol
• Integrate visits with existing schedule to maximize efficient workflow and patient turnaround
• As deemed appropriate, dispense study medication per protocol and/or IVRS system and 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.
• Follows ALCOA+ - Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available
• Correct errors per SOP
• Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmations is printed
• Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart
• Accurately transcribe data into CRFs, and input into electronic study-specific CRFs, if necessary
• Resolve data management queries and correct source data, as needed
• Record protocol exemptions and deviations as appropriate with sponsor, and complete Memo to File for patient chart and regulatory filing if necessary
• Ensure all sponsor correspondence (e-mails, 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 to the IRB

The duties above are representative of the nature and level of work assigned and may include other duties as assigned/delegated.

EDUCATION REQUIREMENT

Bachelor’s Degree (nursing, pharmacy, other related science)

2+ years clinical research experience

ACRP (CCRC)/SoCRA (CCRP) certification preferred

KNOWLEDGE, SKILLS,ABILITIES

• Medical terminology
• Effective communication (both verbal and written)
• Ability to work in a fast-paced environment
• Detail oriented
• Ability to work collaboratively and cooperatively with others
• Acceptance of direction and constructive criticism
• Experience working with CTMS systems
• Familiar using Microsoft Word, Excel, and Outlook

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Experience level:

• 2 years min

Medical specialties:

• Neurology

Schedule:

• 8 hour shift
• Monday to Friday
• Weekends as needed

Work Location: In person