Work Schedule: Full-Time

Location: Community Hospital

Responsibilities:

1. Preparation, submission and maintenance of regulatory documents for assigned studies including staff training, feasibility questionnaires, site selection, enrollment monitoring, new study applications, site visits, continuing reviews, annual renewals, progress reports, amendments, informed consents, revisions, deviations, serious adverse events, advanced regulatory submissions such as IND and/or IDE applications, and report forms for the IRB, NIH, NCI, FDA, Sponsors, etc.
2. For External Clinical Trials: Provides information to patients, family members and medical providers about local and nationally available clinical trials. Assists with obtaining contact information and/or facilitation of referrals in order to maintain good communication and a strong referral base.
3. For Internal Clinical Trials: Performs screening, recruitment, medical record chart reviews, medical history interviews, preliminary eligibility reviews and ensures that potential subjects are adequately informed about the study before they are consented.
4. Collaborates with and acts as a liaison between the health care team, participants and study-related parties for protocol related clarifications and questions to ensure quality patient care that is protocol compliant.
5. Coordinates all research subject visits to ensure that informed consent(s) and the protocol are adhered to and initiates patient care meetings with the health care team as needed to revise the plan of care as the patient’s condition and study protocol warrant.
6. Recognizes, tracks, and reports adverse events and protocol deviations as required by study protocol or other regulations.
7. Coordinates with clinical staff to obtain study-related biospecimens and participates in sample processing and shipment. IATA training required.
8. Responsible for creating, collecting and maintaining research data and documents (collectively referred to as Research Charts) utilizing sponsor, institution, ALCOA-C, FDA and other applicable requirements.
9. Performs timely and accurate data submission and query resolution in the CRF databases per sponsor requirements.
10. Schedule, coordinate, prepare for and participate in interim monitoring, auditing and study closure visits. Addresses queries and makes corrections to study data, as appropriate, as to avoid any delinquencies.
11. Maintains current knowledge of institutional policies, industry guidelines, and legal regulations governing research in order to provide education and guidance to research committees, hospital administration, investigators, sponsors and staff (on research related topics).
12. Participates in the development of policies, procedures and process improvements with specific effort on improving the patient’s research experience while adhering to all required regulations.
13. Support all aspects of Research Finances including contracts, budgets, coverage analysis, invoice processing, study billing, review of patient billing/communication with billing team and payment processing.
14. Keeps current on advances in research conduct and regulations by participating in conferences, educational programs, sponsor, investigator, and/or national and international research consortia meetings.
15. Contributes to developing educational materials for the purposes of educating staff and the community regarding general research information, research studies, and related research issues. Mentors and/or trains new or junior research staff.
16. Other duties as assigned.

Requirements:

• Associate or Bachelor’s degree in science related field (Preferred) or equivalent 

• (1) one year of Oncology Experience (Preferred)

• (1) one year of Research Experience (Preferred)

• Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations, having at least a basic understanding of research procedures

Certifications:
ACRP / SOCRA certification within 6 months of being eligible (SOCRA is preferred);
CITI and IATA within 30 days of being hired.

This position's hiring pay range is: $28.00 - $32.20 per hour, depending on education and experience.

Discretionary bonuses, relocation expenses, merit increases, market adjustments, recognition bonuses and other forms of discretionary compensation may be paid to eligible employees based upon organizational and individual performance.

Benefits:

Employees are eligible to participate in an attractive benefits package including medical, dental, vision, paid time off, education assistance, 403(b) with employer matching, and more. Eligibility is based on employment status. Details regarding specific benefit you may be eligible for will be discussed during the hiring process.

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