CRC I - Newborn Medicine (tuftsmedicine)
Job posting number: #238755 (Ref:R17112)
Job Description
Job Profile Summary
Job Overview
This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned.
Job Description
Minimum Qualifications:
1. Bachelor’s degree OR High School Diploma or equivalent AND Four (4) years of related experience.
2. Basic Life Support (BLS) certification may be required based on specific role requirements.
Preferred Qualifications:
1. Two (2) years in research related activities.
2. IATA Hazardous Good Shipping certification.
3. CITI Human Research Protection certification.
Duties and Responsibilities: The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned.
1. Assists in the recruitment of study participants.
2. Completes follow up with study participants in prescribed settings as required.
3. Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods.
4. Complies with all institutional policies and government regulations pertaining to human subjects protections. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board.
5. Assists with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review such as amendments, adverse event reporting and annual reviews.
6. Performs basic laboratory activities as needed.
7. Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.
8. Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor.
9. Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
10. Participates in site visits with the study sponsor to review completeness and accuracy of study documentation.
11. Maintains inventory of all study supplies.
12. Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements.
13. Reviews all eligibility and ineligibility criteria in the patient’s record.
14. Verifies information with the physician.
15. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.
16. Conducts a QC check of completed CRFs prior to submission for data entry.
17. Coordinates resolution of all data queries.
18. Completes data entry as warranted.
19. Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests, etc.
Physical Requirements:
1. Typical clinical and administrative office setting.
Skills & Abilities:
1. High degree of organizational talents, data collection, and analysis skills.
2. Requires meticulous attention to detail.
3. Excellent computer skills including word processing.
4. Ability to prioritize quickly and appropriately.
5. Excellent communication and interpersonal skills.
6. Systematic record-keeping.