Works with PI, but functions independently; responsible for the complete coordinator of assigned clinical research activities. May have supervisory responsibilities of study staff.
1. Conducts study start-up activities and prepares and maintains all regulatory documents required by sponsor and/or regulatory agencies.
2. Prepares protocols, informed consent documents, modifications, renewals and other necessary documents for review by the IRB and/or sponsor.
3. Coordinates study conduct with other departments to effectively implement clinical research projects; obtains required letters of support and/or approvals as needed (i.e. IBC, SRC, etc.) and protocol is followed.
4. Identifies and recruits eligible study subjects; conducts informed consent/assent process.
5. Arranges and conducts clinical research visits.
6. Conducts site qualifications, study initiation, monitoring and/or close-out visits.
7. Attends investigator meetings.
8. Abstracts data from medical records and enters medical information/data onto protocol specific case report forms, study flow sheets, and other required study forms; prepares abstracted/coded data for processing/analysis.
9. Creates and/or updates case report forms and/or source document templates.
10. Coordinates reimbursement of subjects.
11. Maintains inventory of supplies/equipment.
12. Prepares lab kits and requisitions prior to visits.
13. Collects specimens from subjects and processes specimens or works with Research lab to ensure samples are processed/sent out correctly.
14. Records data on source documents and CRF�s and/or electronic web based systems.
15. Conducts literature searches and assists with QA/QC procedures.
16. Monitors/assesses adverse events and reports them as required.
17. Adheres to research protocol in compliance with applicable institutional, local and federal regulations (OHRP, FDA, GCP, etc.).
18. Functions as patient liaison for study questions, billing issues, etc.
19. Maintains all study documents (regulatory binders, source documents, correspondence, etc.).
20. Promotes the ethical conduct of research by actively participating in research related educational meetings/conferences (planning, presenting, etc.).
21. Performs job functions adhering to service principles with customer service focus of innovation, service excellence and teamwork to provide the highest quality care and service to our patients.
22. QA/QC checks for database validity and data monitoring.
23. Tracking deadlines for grants/deliverables.
24. Coordinates multiple and/or more complex clinical research protocols.
25. Assists in the preparation of budgets and fund management.
26. Assists in the training of personnel for role in study conduct; maintains delegation of authority and training logs.
27. Verities participant eligibility.
28. Evaluates new protocols for feasibility.
29. Manages site visits and responds to sponsor queries/requests promptly.
30. Prepares for and facilitates external audits by sponsor, regulatory agencies (OHRP, FDA, etc.).
31. Assists in the conduct of statistical analysis.
32. Participates in evaluation and process improvement for clinical research studies and/or processes.
33. Prepares study invoices and study billing.
34. Functions as a mentor/resource to other CRPs.
35. Collaborates on the preparation of abstracts/posters for scientific meetings and manuscripts for publication.
36. Presents research/data at national meeting via posters, presentations, etc.
37. With the PI, ensures study activities are per5formed in accordance with the protocol and all applicable institutional and federal regulations.
38. Registers study with clinicaltrails.gov if applicable.
39. Assists investigators with submission of required documents to regulatory authorities (e.g. FDA) when applicable. 40. Promotes the ethical conduct of research and Lurie Children�s by serving in a leadership/appointed role of an internal/external clinical research committee (e.g. CRP Steering/Education Committee, Local ACRP/SOCRA Chapter, National Research Consortium, etc.).
41. Building codebooks for data dictionaries.
42. Assists PI with grant preparation and reporting.
43. Develops protocol of investigator-initiated projects; May managed multiple investigative sites for multi-center research; Leads collaborative studies.
44. Prepares and negotiates budgets with sponsors; Provides oversight of study charges to fund accounts and ensures timely and accurate invoicing.
45. Leads the development, implementation and evaluation of multiple or complex clinical research studies.
46. Trains, mentors and supervises daily activities of staff and students.
47. Develops systems for assuring protocol adherence and data quality.
48. Assists Principal investigator (PI) with grant preparation and reporting.
49. Performs independent statistical analysis of clinical research data or works with study statistician on analysis.
50. Acts as an internal and external CRP leader to Lurie Children�s advising staff regarding complex protocols and projects.
51. Prepares manuscripts for publication and other presentations, as applicable.
52. Coordinates presentations and facilitates at internal/external clinical research education conferences and events. 53. Leads activities designed to improve organizational performance.
54. Leads any audit preparation and responds to any audit findings with PI.
55. Develops division/department SOPs consistent with best practices to enhance the ethical conduct of research.
56. Generates figures for grants, manuscripts and reports.
57. Lead grant submission manager (writing, coordination with OSP).
58. Onboarding of new staff.
59. Generates tables and formatting.
60. Conduct statistical analysis in SPSS, SAS, Stata
1. Bachelors with five to seven years clinical research experience.
2. Prior leadership experience preferred.
3. Strong analytical and organizational skills. Strong customer service skills.
4. Strong verbal and written communication skills in order to address diverse/large audiences.
5. Must be assigned to a status of 0.5 fTE or higher.
6. Demonstrated working knowledge of regulatory practices required.
7. Certification as a Clinical Research Professional (SOCRA) or Clinical Research Coordinator (ACRP) required.
8. Proficient in using advanced Excel formulas like VLOOKUP and COUNTIF/IF
9. Proficient in using pivot tables.