Regulatory Research Coordinator I

Job Summary:
This role is responsible for preparing, completing, and submitting required forms and documents, in consultation with the research team, to meet regulatory, IRB, and HIPAA guidelines and policies, at the time of initial review, modifications, and continuing review. The Research Regulatory Coordinator II has a direct line of communication and working relationship with external investigators and/or research teams. Performs informed consent review and modifies consent form/HIPAA language while working with sponsors and IRBs for all studies to conform to institutional guidelines. During times of staff shortage must be able to cross cover for Research Coordinator II positions as needed for patient enrollments and care.

Education:
Required:
Associates Degree and/or 2 - 3 year's equivalent work experience in clinical research or other related field.

Preferred:
Graduate from an accredited School of Nursing.

Experience:
Required:
2 - 3 year's prior experience in a research medical office or academic hospital setting or other related field.

Knowledge of personal computing with word processing, spreadsheets and database management. Basic understanding of medical terminology. Self-motivated, professional and accountable. Detail oriented with ability to handle multiple tasks/projects simultaneously. Must be able to plan, prioritize and complete tasks under stress with frequent interruptions.
Familiarity with the Code of Federal Regulations as they pertain to human subject clinical research.

Strong interpersonal skills.

Understanding of clinical research process.

Highly motivated with the ability to take initiative in supporting the research department.

Preferred:
Two years or more of research regulatory experience strongly recommended.

Knowledge and understanding of application of approved clinical practices.

Experience with research and/or grants and in health care system.
Phlebotomy training and/or experience.

Position Requirement(s): License/Certification/Registration
Required:
Clinical Research Certification (SoCRA, CCRP or ACRP) or be able to obtain within 2 years from hire date. Certification in Institution Review Board required Course in The Protection of Human Research Subjects (CITI) course, Conflict of Interest and Good Clinical Practice; International Air Transportation Association (IATA) certification for shipping dangerous goods and biological substances. If certification is not current at hire date, then these must be completed within the first 3 months of employment. Current Driver's License.

Preferred:
Clinincal Research experience. Experience in regulatory affairs in industry. Research certification with Prim&r or RAC.

Department Position Summary:
Assist senior regulatory and/or research coordinator with review of case report forms, informed consents, and other study related material. Assists with maintaining monthly billing for study visits and documents appropriate fees on research referral forms. Assists with the collection of data from patient charts, medical records, interviews, questionnaires and other sources. Works with senior coordinators to oorganize and facilitate meetings, conferences, and other events associated with research activities; may perform and/or coordinate outreach activities, as appropriate for research objectives. Submits all research related contracts and supporting documents to IRB Administrator to be entered into Contract Collaborator and keeps track of their progress as they move through the system, giving weekly updates to management acting as a secondary monitor in the process.

Updates a department-wide Microsoft Outlook calendar, keeping research team informed of appointments, meetings, vacations, and other departmental events. Assist with developing and maintaining up to date departmental policies and procedures as needed. Assists with the maintenance of departmental information ensuring up-to-date faculty CVs, current licensures, lab certifications, lab normal and abnormal values, staff training certifications along with any additional protocol specific requirements. Works with Marketing to ensure currently enrolling studies are updated on EHS website. Performs special projects as assigned.

During times of staff shortage must be able to cross cover for Research Coordinator II positions as needed for patient enrollments. Must have understanding of all federal and local agencies including (but not limited to) the Food and Drug Administration (FDA) and local Institutional Review Board (IRB) as well as the Central Institutional Review Board (CIRB) with ability to work within all guidelines set forth. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

Must be a professional, multi-skilled person dedicated to assisting in all aspects of research practice. Must be able to plan, prioritize and complete tasks under stress with frequent interruptions. Under direction of the Senior Regulatory or Senior Research Coordinator prepare, complete, and submit required forms and documents, in consultation with the research team, to meet regulatory, IRB, CIRB and HIPAA guidelines and policies, at the time of initial review, modifications, and continuing review.