Acts as a specialist of patient recruitment processes/documentation requirements for the start-up and conduct of clinical trials according to Good Clinical Practice and local regulations. Serves as primary contact for Company personnel. Assumes the project role of Patient Recruitment Specialist; coordinates the creation and quality review of patient recruitment materials required for Phase I-IV studies, as per project assignment. Responsible for advising the project team on potential patient recruitment issues that may impact the conduct of the study.
1. Reviews study documents (protocols, advertisements, informed consents, subject information templates, etc.) in the development of patient recruitment tools and verification of the patient recruitment strategy.
2. Develops site start-up timelines pertaining to Patient Recruitment activities.
3. Obtains patient recruitment material development process requirements from the sponsor and ensures that all requirements are documented in the Patient Recruitment Plan and are implemented consistently throughout the trial. Responsible for the development, finalization, and periodic updates to the Patient Recruitment plan throughout the trial. Creates, analyzes, and implements site level recruitment plans based on the study and Patient Recruitment plan requirements.
4. Provides all patient/caregiver facing materials for regulatory (IRB/EC/CA/RA) to Regulatory project team counterpart and provides clinical facing materials, if required. Assists in the resolution of issues relating to (IRB/EC/REC) submission and approval processes.
5. Ensures the timely transfer of documentation to the Trial Master File (TMF) as defined in applicable Standard Operating Procecures (SOPs).
6. Creates required documentation and liaises with vendors and/or internal Company associates in the development of study branding.
7. Manages vendors to deliverables associated with contract services.
8. Serves as a contact for sponsor, Clinical Monitoring, Project Leader, and clinical site staff to answer questions pertaining to patient recruitment materials and strategies.
9. Reviews internal documentation from Clinical Trial Regulatory to ensure approval prior to printing and distribution of materials.
10. Performs a final quality control review of patient recruitment documents.
11. Ensures documents are appropriately tracked in Company’s Clinical Trial Management System (CTMS).
12. Reviews and negotiates site-specific text edits in accordance with the protocol and all applicable regulatory guidelines; this can include ICF, minor assent, and/or protected heath information consent documents.
13. In collaboration with Project Leader and other project team members, coordinates the timely distribution of materials to sites upon activation.
14. Participates in both internal and external project team meetings to provide concise and timely status updates, as well as discussions regarding strategic initiatives in association with patient recruitment. Completes site status update reports and distributes to the project team. Completes weekly, monthly, and executive status reports of all studies for department manager; reviews the study progress and issues with department manager.
15. Monitors clinical site and country activities to assess and facilitate site conversion from start-up to patient enrollment.
16. Anticipates/identifies potential problems and communicates to the project team. Suggests and implements alternative solutions to problems with study timelines, schedules, resources, etc.; implements corrective action plans.
17. Actively maintains project related documents in departments central repository.
18. Performs tasks within the hours budgeted for the study; communicates all out-of-scope activities to the department manager, Project Leader, and Site Start-up Manager, if assigned.
19. Responsible for providing information for negotiations with outside vendors, e.g., translation services, branding, if applicable.
20. Reviews and finalizes site, patient, and project team communication tools prior to distribution.
21. At the conclusion of Patient Recruitment activities, ensures that the patient recruitment aspect of the TMF is complete and accurate.
22. Attends investigator meetings as required to train project team and/or investigators on the patient recruitment strategies, tools, tactics, and systems for the study.
23. Participates in quality improvement efforts to increase overall operational efficiency.
24. Participates in internal and sponsor audits.
25. Assists in the development of department SOPs, Work Instructions, and/or Guidelines.
26. Oversees the development and maintenance of study-tracking solutions.
27. Acts as contact point for Project Leader and/or Site Start-up Manager for patient recruitment issues, ensuring appropriate flow of information and documentation.
28. Maintains working relationship with study team members.
29. Responsible for internal and external customer relationship management.
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
BA/BS in the life sciences, marketing, communications, business administration, related discipline, or equivalent education and experience. Experience working in a pharmaceutical, biotech, or contract research organization. In-depth knowledge and application of GCP, FDA, and ICH guidelines. Understanding of marketing and advertising strategies. Strong presentation, communication (oral and written), documentation, and negotiation skills. Proficient in Microsoft Office suite (Word, Excel, and PowerPoint), email, and voicemail. Microsoft Publisher experience preferred. Ability to understand and interpret clinical protocols and associated study specifications. Valid, current driver’s license and ability to secure corporate credit card.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.
Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
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