Research Assistant
Job Description

Mission Statement:  We provide a service for trial participation in the Ormond Beach community demonstrating by our actions the love of Christ to everyone with whom we come in contact. We provide studies in outpatient multi-therapeutic areas focusing on obesity, metabolic disorders, HIV and other Infectious Diseases.

Overview:
You are the first point of contact for our site.  You must be aware of the activities taking place within our research center at any given time of the day.  A positive demeanor is necessary at all times.  This position is the Assistant to everyone.

Duties include, but are not limited to:
1. Answer the doorbell
2. Answer the telephone with a professional tone as follows:
(a)        Peninsula Research
(b)        Good Morning
(c)        This is _____________ speaking
(d)        How can I help you?
If necessary to take a message, put all the information in the message, e.g. date, time, from (name) with (Sponsor) protocol number, their phone number, to who, and regarding
3. Greet the patients in a professional manner
4. Make a copy of patient’s photo ID
5. Tell the Coordinator that the patient has arrived for their visit
6. Assist the Coordinator with a patient’s visit, to include but not limited to, taking the patients vital signs, weight, and study medication counting, if necessary
7. Schedule the patient’s next appointment after they complete their visit with the Coordinator  Schedule appointment with doctor’s office, if applicable
8. Schedule x-rays and any other protocol required procedures
9. Call the patient the night before to confirm their time and visit for the next day.  Give them any necessary protocol specific instructions.  Remind them to bring all study medication/supplies with them
10. Place the patient charts on top of the work station in the hallway that are needed for the next day  Check to be certain any loose documents are in the chart for the visit, e.g., patient diaries and/or questionnaires
11. Put the labs that are needed for the next day in the lab, in a blue bin with the patient’s initials and number on the bin
12. Verify the lab sample shipping bag/box and airbill are prepared and ready to be sealed once the labs are completed
13. Once the Investigator has reviewed and signed the lab results, enter this data in patient’s chart on the flow sheet
14. On a daily basis call and schedule DHL, Federal Express, Quest, UPS for pick-up of labs and other outgoing items
15. On a daily basis bring the Investigators’ signature folders to their office and pick up the previous days folder.  If the Investigator leaves a message on the folder give it to the correct Coordinator to address the issue.
16. Set up patient charts in the conference room the night before a monitor visit
17. Print out and distribute the schedule for the next day
18. Obtain the required training and your own password to assist the Coordinator with study data entry
19. Assist the Coordinator to transcribe information from the source documents to the Case Report Form (CRF) or Electronic Data Capture (EDC)
20. Create and maintain a Master Patient Binder
21. Assemble all patient binders for the studies
22. Create Source Documents, if applicable
23. Replace older version Source Documents with newer version in the Master Patient Binder along with each ongoing patients’ chart
24. Prepare a study specific recruiting form which will be approved by the President
25. Maintain log book of study supply requisitions and place orders as needed
26. Monitor and order lab kits in a timely manner
27. Keep patient filing up to date
28. Enter new patient information in CTMS
29. Update existing patients’ medical history in CTMS
30. Recruit for all enrolling studies
31. Assist the Regulatory Specialist to process new Informed Consent Forms (ICF) by copying and placing in the document drawer in the front hallway.  Prepare the drawer with labeled tabs for the main ICF, mailing ICF, ICF Medical Hx, Dr. Start Letter, Dr. End Letter
32. Assist the Regulatory Specialist to prepare the Receipt of ICF, the Dr. Start Letter, Dr. End Letter
33. Assist the Regulatory Specialist to process revised ICFs by placing copies in the front flap of the Source Document binder, for each active patient, along with a receipt of Revised ICF.  Remove and shred the older ICF versions from the front hallway drawer and put in the revised versions.
34. Assist the Regulatory Specialist to archive closed study documents, to include boxing, bar coding, and calling for pickup
35. Call to order lunch for monthly Physician meetings
36. During down time randomly call patients to verify their information entered in CTMS
37. Stagger your lunch with others so the front office maintains coverage

Skills and Knowledge:
1. Interpersonal and communication skills – interact effectively with professionals, administrative staff, sponsors and regulatory representatives, patients, potential subjects, and referral sources.
2. Well organized with attention to detail
3. Familiarity with data entry software
4. Must have the ability to multi-task
5. Have the knowledge to work independently
6. Willingness to work as part of a team with staff and volunteers

Salary and Benefits:
1. Hourly pay
2. PTO
3. Health Insurance as per Benefits Plan

Reports to:
1. Peninsula Research, Inc. Lead Coordinator