Posted in Other about 2 hours ago.
GENERAL SUMMARY/ OVERVIEW STATEMENT:
Working very independently and under very general supervision from Research Manager and/or Principal Investigator, provides support to clinical research studies. May be responsible for the following activities: making independent judgment of suitability of potential participants for clinical trials and registries, screening and scheduling potential participants for clinical trials, developing and implementing patient recruitment strategies, performing applicable clinical tests such as phlebotomy, vital signs, etc. maintaining and updating data generated by the study.
JOB DESCRIPTION:
1. Working with other research coordinators supporting clinical research activities for department.
2. In conjunction with Research Manager/Principal Investigator, develops and implements new research protocols including design, data collection systems and institutional review board approval.
3. Recruitment of patients for enrollment in clinical trials and registries. Interacts with patients prior to entering the study and throughout the entire treatment. Discusses and obtains informed consent with patients.
4. Organizing strategies for recruiting study patients.
5. Screening patients for eligibility and enrolling eligible candidates.
6. Conducting study visits.
7. Working closely with the Principal Investigator and other staff on implementing clinical studies and registries.
8. Preparation of protocol applications, maintaining regulatory binders, case report forms, source documents, and other study documents as well as monitoring and reporting the occurrence of clinical adverse events.
9. Maintaining and updating information as required by Hospital and Sponsor/NIH guidelines.
10. IRB applications and submission
11. Manage study finances: maintain positive financial status of studies, prepare invoices and track payments, facilitate subject payment and reimbursement as applicable per study contract
12. Following informed consent guidelines with study patients
Investigator support
1. Organize meetings and meeting schedules
2. Manuscript and presentation preparation: literature reviews, citation management, drafting, basic data manipulation, table and figure creation
3. Clinical operations support as needed
Qualifications
EDUCATION:
AstraZeneca |
Harvard University |
Brigham & Women's Faulkner Hospital(BWFH) |