Clinical Trials/Patient Coordinator

Re:Cognition Health Limited; Fairfax (VA); Vor Ort; USD 55.000 - 85.000; Vollzeit

Zusammenfassung

Re:Cognition Health Limited is seeking an experienced Clinical Trials Coordinator to manage activities across the full trial lifecycle in Fairfax, VA. The role requires collaboration with investigators, sponsors, and cross-functional teams to ensure GCP-aligned delivery.

You will coordinate private practice support, schedule visits, manage patient records, and ensure HIPAA/GDPR compliance while maintaining high standards of patient care and data integrity.

Qualifikationen

• 3–5 years experience in Clinical Trials Coordination, operation, set-up and delivery.
• 1–2 years experience in Healthcare setting, preferred.
• Proficiency in Microsoft Office packages (Word, Excel, PowerPoint).
• Experience with electronic data capture (EDC) systems (CRIO preferred) and electronic health records (EHR) systems (Azalea Health EHR preferred).

Aufgaben

• Ensure highest levels of patient care and clinical delivery at all times.
• Support business development by working with clinicians to recruit patients.
• Ensure SOPs are followed and staff trained and compliant.
• Ensure accurate and timely entry of patient records in databases and forms.
• Maintain patient records securely per data protection requirements.
• Maintain Center to high standards and ensure equipment is calibrated and maintained.
• Ensure adequate stock in the Center is ordered timely and controlled.
• Collect patient feedback and analyze to improve services.
• Handle queries, SAE and IRB/FDA reporting within required time frames.
• Coordinate all visits for monoclonal antibody infusions.
• Schedule appointments, scans, labs, and follow-ups in collaboration with physicians.
• Manage confirmations, rescheduling, and reminders.
• Liaise with radiology centers, laboratories and external providers.
• Work with PC Manager and physicians for efficient patient flow.
• Maintain up-to-date patient medical records.
• Facilitate secure transmission of medical documents.
• Ensure HIPAA and GDPR compliance in handling patient data.
• Be point of contact for referring physicians on progress and docs.
• Participate in weekly team meetings for patient updates.
• Ensure collaboration between clinical research and PC teams.
• Perform vital signs (BP, pulse, etc.) and EKGs.
• Monitor patients during infusions and report concerns.

Kenntnisse

Clinical Trials Coordination

Healthcare setting experience

Microsoft Office

Data entry / record management

Tools

CRIO EDC

Azalea Health EHR

Jobbeschreibung

The ideal candidate will have a strong background in clinical trial coordination, with the ability to independently manage study activities across the full trial lifecycle-from study start-up and initiation through ongoing trial conduct and final study closeout—while also collaborating effectively with investigators, sponsors, and cross-functional teams. We are also looking for someone who is local to Fairfax, VA area and available to start as soon as possible.

About the role

• The post holder will be held accountable to the Clinical Trials Center Manager for the highest standards of operational delivery of the Clinical Trials for which the post holder is appointed to co-ordinate. This includes responsibility for delivering these trials according to clinical trials Good Clinical Practice (GCP), ensuring appropriate resources, including professional skill mix, training and competency are in place at all times. Additionally, this person will ensure practice at the center is safe, performance at CRA visits, external monitoring visits and FDA inspections are planned and executed for optimal success.

What you’ll do

• To ensure that the highest levels of customer/patient care and clinical delivery are maintained at all times
• To support the development of the business by working closely with clinicians and consultants to maximize business opportunities and recruit patients
• Adhere to the organization’s policies and SOPs and ensure all members of the clinical trials team are trained and compliant
• To ensure that all administration is performed accurately and in a timely way including the entry of patient records on all necessary databases and forms
• To ensure that all patient records are accurate, stored appropriately and all confidential information is retained in accordance with data protection requirements
• To ensure that the Center is maintained and presented to the highest standards as expected by
• The organization and that all equipment is calibrated and maintained in line with best practice
• To ensure adequate stock within the Center ensuring that it is ordered in a timely way and that stock is controlled
• To seek feedback from patients as to their experience and record these findings and analyze them to support the ongoing development of the service
• To be responsible for answering all queries and SAE and related IRB/FDA reporting within the time frames dictated for each study and GCP

Private Practice Support:

• Coordinate all patient visits for monoclonal antibody infusions.
• Schedule appointments, scans, lab tests, and follow-up visits in collaboration with physicians and external providers.
• Manage appointment confirmations, rescheduling, and patient reminders.
• Liaise with radiology centers, laboratories, and external medical providers.
• Work closely with the PC Manager and physicians to ensure an efficient patient flow.
• Maintain accurate and up-to-date patient medical records.
• Facilitate secure transmission of medical documents between referring physicians and internal teams.
• Ensure HIPAA and GDPR compliance in handling patient data.
• Serve as a point of contact for referring physicians regarding patient progress and documentation.
• Participate in weekly team meetings to discuss patient updates and workflow improvements.
• Ensure smooth collaboration between clinical research and PC teams.
• Perform vital signs assessments (blood pressure, pulse, respiratory rate, temperature, etc.).
• Conduct electrocardiograms (EKGs) and ensure accurate documentation.
• Monitor patients during infusion sessions, reporting any concerns to medical staff.

Qualifications

• 3-5 years experience in Clinical Trials Coordination, operation, set-up and delivery, required.
• 1-2 years experience in Healthcare setting, preferred.
• Proficiency in the use of Microsoft Office packages (Word, Excel, PowerPoint)
• Experience with electronic data capture (EDC) systems (CRIO preferred) and electronic health records (EHR) systems (Azalea Health EHR preferred)