RESEARCH EDUCATION,
TRAINING & COMPLIANCE

HIRING CLINICAL RESEARCH STAFF

If you are hiring clinical research staff for your department who will:

1. have direct contact with a study subject whether in person or by telephone and/or;
2. be obtaining informed consent to participate in a study and/or;
3. be preparing IRB submissions that may include, but are not limited to the initial request for approval to conduct a study and/or submitting amendments or SAE(s) (serious adverse event) reporting, etc.

They will need to be hired under one of the five research job descriptions listed below. The employee must be hired on The MetroHealth System payroll.

All non-physician human subject research staff have dial reporting; to the Principal Investigator or Manager, Clinical Research, and Assistant Director, Clinical Research, which ever is appropriate. On the job requisition for the position you wish to fill you must include Assistant Director, Clinical Research as one of the persons to whom the position reports. The job offer letter needs to indicate the reporting structure as well.

The job offer letter must also include the statement that the employee will complete the Clinical Research Orientation Program within 90 days of hire. All new hires are required to complete The MetroHealth System hospital orientation. If the applicant is a nurse, they are also required to complete The MetroHealth System nursing orientation.

Should you have any questions about filling a research position in your department please contact Kelly Robertson at krobertson@metrohealth.org.

THE METROHEALTH SYSTEM
Job Description

Job Title Research Administrative Associate
Created 03/18/02
Reports To Primary Investigator/Assistant Director, Clinical Research
Reviewed
Job Code 072208
Revised
Department As Assigned
Job Status Non-Bargaining
Location As Assigned
Job Grade 24
Scope The MetroHealth System
FLSA Status Non-Exempt

Job Summary
Assists in the preparation of Institutional Review Board (IRB) submissions for studies and serves as liaison between Principal Investigator (PI) and IRB and sponsor. Upholds the standards of the system-wide customer service and compliance program.

Responsibilities
1. Assists in the preparation of protocol documents for IRB submission.
2. Assists in budget preparation and reconciliation.
3. May coordinate all site visits, which may include pre-study, initiation and closeout visits with key personnel and Clinical Research Associate/Clinical Research Organization (CRA/CRO).
4. Maintains accurate and essential documents as required by FDA, IRB, sponsor and other regulatory agencies or funding agency.
5. Coordinates monitoring visits with sponsor monitor and acts as liaison with PI and monitor/sponsor.
6. May be required to prepare/assist with grant application.
7. May be required to prepare abstracts.
8. Develop positive working relationships with ancillary department to ensure smooth study progress.
9. May be required to prepare advertising for recruitment of subjects (requires prior IRB approval).
10. Keeps abreast of regulatory agency compliance requirements and patient safety issues.
11. Maintains data integrity where applicable.
12. May be required to assist in preparing for FDA and internal audits.
13. May be required to maintain databases for department.
14. Other tasks as determined by department not requiring a state licensure.

Required Qualifications
High School Graduate or GED equivalent
One year secretarial experience in a medical or research setting.
Excellent interpersonal, written and verbal communication skills.
Good organization and problem solving skills.
Ability to work independently.
Demonstrated proficiency in personal computers and various software and database applications.

Preferred Qualifications
Two years experience working with Federal Regulations relating to human subject research.
Institutional Review Board (IRB) experience.
Associate's Degree
Certified clinical research coordinator (CCRC).
Five years experience working with Federal Regulations relating to human subject research.

I have read and understand the job description and qualifications for the position for which I have applied.

Applicant Signature

Date Signed

THE METROHEALTH SYSTEM
Job Description

Job Title Research Project Associate
Created 03/05/02
Reports To Primary Investigator/Assistant Director, Clinical Research
Reviewed
Job Code 072209
Revised
Department As Assigned
Job Status Non-Bargaining
Location As Assigned
Job Grade 25
Scope The MetroHealth System
FLSA Status Exempt

Job Summary
Plans for, delivers, documents and observes progress of subjects enrolled in research studies according to study protocol. Upholds the standards of the system-wide customer service and compliance program and complies with The MetroHealth System policies and procedures.

Responsibilities as delegated by principal investigator (PI) and scope of licensure (where applicable) as defined by the State of Ohio.

Clinical
1. May recruit and screen subjects for eligibility as described in protocol.
2. Obtains informed consent prior to scheduling any study procedures. This is a continuing process throughout the clinical trial.
3. Conducts study(s) visit as specified in protocol and MetroHealth's polices and procedures; assuring all specifics of protocol are met and notifies Institutional Review Board (IRB) of deviations and/or violations from study and.
4. Schedules subject visit(s) according to schedule of evaluations in protocol.
5. Coordinates/schedules required services of ancillary departments for the subject's visit.
6. Registers subject for study visit in EPIC assuring that research account is charged correctly where required. This is required for all visits on a Metro campus, i.e., clinics, labs, etc.
7. Responsible for accurately completing and submitting Case Report Forms (CRF) in the time requirements specified by sponsor where applicable.
8. Reports subject's progress on study to principal investigator and immediately informs PI of adverse events experienced by participants.
9. Schedules tests/procedures as specified in protocol and per physician's orders.
10. May be required to obtain follow-up information from subjects via telephone as specified in study.

Administrative
1. May be required to assist in preparation of protocol documents for IRB submission.
2. May be required to assist in preparation of budget for clinical trials.
3. May coordinate all site visits, which may include pre-study, initiation and closeout and periodic monitoring visits with key personnel and clinical research associate/clinical research organization (CRA/CRO).
4. Maintains accurate and essential documents as required by FDA, IRB, sponsor and/or funding agency.
5. May be required to prepare/assist with grant application.
6. May be required to prepare abstracts.
7. Develop positive working relationships with ancillary department to ensure smooth study progress.
8. May be required to act as liaison between investigator and the IRB and sponsor where applicable.
9. May be required to prepare advertising for recruitment of subjects (requires prior IRB approval).
10. Keeps abreast of regulatory agency compliance requirements and subject safety issues.
11. Maintains data integrity.
12. Manages study supplies where applicable.
13. May be required to assist in preparing for FDA and internal audits.

Required Qualifications
Completion of three years of a Bachelor's degree in a related field as well actively pursuing completion thereof and/or current licensure as required by specialty determined by department.
Good organization and problem solving skills and ability to work independently.
Proficiency in personal computers and various software and database applications.
Excellent interpersonal, written and verbal communication skills.
One year experience working in research with human subjects or clinical experience. NOTE: May have additional requirements depending on department that will be indicated on position posting.

Preferred Qualifications
Bachelor's degree in related field.
Institutional Review Board (IRB) experience.
Certified clinical research coordinator (CCRC).

I have read and understand the job description and qualifications for the position for which I have applied.

Applicant Signature

Date Signed

THE METROHEALTH SYSTEM
Job Description

Job Title Research Nurse
Created 10/01/84
Reports To Primary Investigator/Assistant Director, Clinical Research
Reviewed
Job Code 120022
Revised 03/06/02
Department As Assigned
Job Status Non-Bargaining
Location As Assigned
Job Grade 27
Scope The MetroHealth System
FLSA Status Exempt

Job Summary
Plans for, delivers, documents and observes progress of subjects enrolled in research studies according to physician's orders and study protocol and in compliance with approved and recognized standards of nursing care ,nursing techniques and procedures and administrative policy as delegated by physician. Maintains accurate and timely documentation of study visits and notifies Institutional Review Board (IRB) of deviations or violations from study protocol. Notifies IRB of adverse events in accordance with time frame established by IRB. Upholds the standards of the system-wide customer service and compliance program. Works within scope of nursing practice as defined by the State of Ohio. Follows MetroHealth System policies and procedures.

Responsibilities
Clinical
1. Recruits and screens subjects for eligibility as described in protocol.
2. Obtains informed consent prior to performing any study procedures. Informed consent is a continuing process throughout the clinical trial.
3. Conducts study visit as specified in protocol; assuring all specifics of protocol are met and notifies IRB of deviations/violations from study procedures.
4. Schedules subject visit(s) according to schedule of evaluations in protocol. Registers subjects for study visit in EPIC, assuring that the appropriate research account is charged where required. This is required for all visits on a Metro campus, i.e., clinic, labs,etc.
5. Coordinates/schedules required services of ancillary departments for the subjects visit.
6. May provide any necessary training/instruction to research staff and ancillary departments so required procedures be performed in accordance with protocol.
7. Maintains accurate and complete source documentation to meet FDA and sponsor and all applicable regulatory agency regulations/requirements.
8. Manages adverse events at the direction of the physician and protocol management guidelines. Notifies study manager and/or IRB and sponsor of adverse events in accordance with IRB and sponsor guidelines. Immediately notifies Risk Management office of internal serious adverse events.
9. Responsible for accurately completing and submitting Case Report Forms (CRFs) in the time requirements specified by sponsor as applicable.
10. Must be knowledgeable of all regulatory requirements in conducting research involving human subjects.
11. Educates study subjects regarding nature of illness/disease and of medication adherence, timing, dosage, frequency and potential side effects where applicable. May be required to prepare written educational material for participants (note IRB approval required prior to distributing to participants). Encourages subject compliance to study regimen.
12. Administers study medication (when applicable) as ordered by physician.
13. Informs Primary Investigator of patient's progress on study and immediately informs PI of adverse events experienced by participants.
14. Performs/schedules tests/procedures as specified in protocol and within scope of state licensure regulations.
15. Assesses participant's condition and reviews lab results immediately upon receipt and immediately informs study physician of abnormalities.
16. Maintains and demonstrates current knowledge of specialty area.
17. Demonstrates clinical judgment/foresight in anticipating variances in research protocols.
18. Demonstrates clinical skills relating to the execution of research protocols.
19. Encourages subjects to participate in exercising their rights as research participants.

Administrative
1. May participate in the identification of relevant new studies.
2. May coordinate all site visits, which may include pre-study, initiation and closeout visits with key personnel and CRA/CRO.
3. Maintains accurate and essential documents as required by FDA, IRB, sponsor and or funding agency.
4. Coordinates monitoring visits with sponsor monitor and acts as liaison with PI and monitor/sponsor.
5. May be required to prepare/assist with grant application.
6. May be required to prepare abstracts.
7. Develop positive working relationships with ancillary department to ensure smooth study progress.
8. May be required to act as liaison between investigator and the IRB.
9. May be required to prepare advertising for recruitment of subjects (requires prior IRB approval).
10. Keeps abreast of FDA, IRB and other regulatory agency compliance requirements and patient safety issues.
11. Maintains data integrity.
12. Manages study supplies where applicable.
13. May be required to assist in preparing for FDA and internal audits.
14. Demonstrates creative, innovative and flexible approaches to problem solving in a research environment.
15. Assists with internal audits
16. Performs other functionally related duties as assigned.

Required Qualifications
Graduate of an accredited school of nursing with current RN licensure in the State of Ohio or a LPN with NAPNES and three years of clinical experience.
One year of clinical experience as a staff nurse.
Good organization and problem solving skills.
Ability to work independently.
Excellent clinical skills.
Demonstrated proficiency with personal computers and various software and database applications.
Excellent interpersonal, written and verbal communication skills.
Current CPR card.
Note: Possesses and maintains competencies per department requirements as indicated on position posting.
Note: May have additional requirements depending on department that will be indicated on position posting.

Preferred Qualifications
Bachelor's degree in nursing or related field.
Certified clinical research coordinator (CCRC).
Experience in research.
Institutional Review Board (IRB) experience.
Knowledgeable of good clinical practice (GCP) in research.

I have read and understand the job description and qualifications for the position for which I have applied.

Applicant Signature

Date Signed

THE METROHEALTH SYSTEM
Job Description

Job Title Coordinator, Research Nursing
Created 03/07/02
Reports To Primary Investigator/Assistant Director, Clinical Research Reviewed:
Job Code 0722211
Revised
Department As Assigned
Job Status Non-Bargaining
Location As Assigned
Job Grade 28
Scope The MetroHealth System
FLSA Status Exempt

Job Summary
Plans for, delivers, documents and observes progress of subjects enrolled in research studies according to physician's orders and study protocol and in compliance with approved and recognized standards of nursing care, nursing techniques and procedures and administrative policy as delegated by physician. Maintains accurate and timely documentation of study visits and notifies institutional review board (IRB) of deviations or violations from study protocol. Notifies IRB of adverse events in accordance with time frame established by IRB. Upholds the standards of the system-wide customer service and compliance program. Works within scope of nursing practice as defined by the State of Ohio. Follows MetroHealth System policies and procedures.

Responsibilities
Clinical
1. Recruits and screens subjects for eligibility as described in protocol.
2. Obtains informed consent prior to performing any study procedures. Informed consent is a continuing process throughout the clinical trial.
3. Conducts study visit(s) as specified in protocol; assuring all specifics of protocol are met and notifies IRB of deviations/violations from study procedures.
4. Schedules subject visit(s) according to schedule of evaluations in protocol.
5. Coordinates/schedules required services of ancillary departments for the subject's visit.
6. May provide any necessary training/instruction to research staff and ancillary departments so required procedures be performed in accordance with protocol.
7. Maintains accurate and complete source documentation to meet FDA and sponsor and all applicable regulatory agency regulations/requirements.
8. Manages adverse events at the direction of the physician and protocol management guidelines. Notifies IRB and sponsor of adverse events in accordance with IRB and sponsor guidelines. Immediately notifies Risk Management office of internal serious adverse events.
9. Responsible for accurately completing and submitting Case Report Forms (CRFs) in the time requirements specified by sponsor as applicable.
10. Must be knowledgeable of all regulatory requirements in conducting research involving human subjects.
11. Educates study subjects regarding nature of illness/disease and of medication adherence, timing, dosage, frequency and potential side effects where applicable. May be required to prepare written educational material for participants (note IRB approval required prior to distributing to participants). Encourages subject compliance to study regimen.
12. Administers study medication (when applicable) as ordered by physician.
13. Informs Primary Investigator of patient's progress on study and immediately informs PI of adverse events experienced by participants.
14. Performs/schedules tests/procedures as specified in protocol and within scope of state licensure regulations.
15. Assesses participant's condition and reviews lab results immediately upon receipt and immediately informs study physician of abnormalities.
16. Maintains and demonstrates current knowledge of specialty area.
17. Demonstrates clinical judgment/foresight in anticipating variances in research protocols.
18. Demonstrates clinical skills relating to the execution of research protocols.
19. Encourages subjects to participate in exercising their rights as research participants.

Administrative
1. Participates in the identification of relevant new studies.
2. Coordinates all site visits, which may include pre-study, initiation and closeout visits with key personnel and CRA/CRO.
3. Maintains accurate and essential documents as required by FDA, IRB, sponsor and or funding agency.
4. Coordinates monitoring visits with sponsor monitor and acts as liaison with PI and monitor/sponsor.
4. Prepares/assists with grant application where applicable.
5. Prepares abstracts as needed.
6. Develop positive working relationships with ancillary department to ensure smooth study progress.
7. May be required to act as liaison between investigator and the IRB.
8. May be required to prepare advertising for recruitment of subjects (requires prior IRB approval).
9. Keeps abreast of FDA, IRB and other regulatory agency compliance requirements and patient safety issues.
10. Maintains data integrity.
11. Manages study supplies where applicable.
12. Assists in preparing for FDA and internal audits.
13. Demonstrates creative, innovative and flexible approaches to problem solving in a research environment.
14. Performs other functionally related duties as assigned.

Financial
1. Prepares study budget as required. Works closely with the Research Administration Business Office and Grants Management Specialist assuring all required documents are submitted in application.
2. Collaborates with investigator and business manager to determine economic feasibility.
3. Reviews and approves study invoices for payment. Determines all invoices are received for services provided by ancillary staff.
4. Meets regularly with their assigned Grants Management Specialist to review budget.

Required Qualifications
Graduate of an accredited school of nursing.
Current RN licensure in the State of Ohio.
Three years experience in a clinical research setting.
Outstanding interpersonal skills.
Excellent clinical skills.
Good organization and problem solving skills.
Ability to work independently.
Demonstrated proficiency in personal computers and various software and database applications.
Excellent interpersonal, written and verbal communication skills.
Current CPR card.
Knowledgeable of good clinical practices (GCP) in research.
Note: May have additional requirements including the specified competencies as required by the department that will be indicated on position posting.

Preferred Qualifications
Bachelor's degree in nursing or related field.
Certified clinical research coordinator (CCRC).
Experience in Institutional Review Board (IRB) process.
Experience in budget preparation.
Knowledgeable of area of department specialty.

I have read and understand the job description and qualifications for the position for which I have applied.

Applicant Signature

Date Signed

THE METROHEALTH SYSTEM
Job Description

Job Title Manager, Clinical Research
Created 02/18/02
Reports To Primary Investigator/Assistant Director, Clinical Research
Reviewed
Job Code 072212
Revised
Department As Assigned
Job Status Non-Bargaining
Location As Assigned
Job Grade 30
Scope The MetroHealth System
FLSA Status Exempt

Job Summary
Coordinates and manages the day-to-day operations of the research department. Supervises the staff under the delegation of responsibilities as mandated by the licensing regulations of the various health regulatory agencies. Upholds the standards of the system-wide customer service and compliance program.

Responsibilities
Clinical
1. Coordinates the recruitment and screening of subjects for eligibility as described in protocol.
2. Coordinates obtaining informed consent by the research coordinators prior to performing/scheduling any study procedures. Informed consent is a continuing process throughout the clinical trial.
3. Assures the study is conducted as specified in protocol; assuring all specifics of protocol are met and notifies IRB of deviations/violations from study procedures.
4. Assures subjects are scheduled according to schedule of evaluations in protocol.
5. Assures subjects are registered for study visit in EPIC so that the research account is correctly charged.
6. Provides any necessary training/instruction to research staff and ancillary departments so required procedures are performed in accordance with protocol and under state licensure regulations regarding delegation and management of licensed staff (RN, LPN, OT, PT, LISW and RD).
7. Maintains accurate and complete source documentation to meet FDA, sponsor and all applicable regulatory agency regulations/requirements.
8. Notifies IRB and sponsor of adverse events in accordance with IRB and sponsor guidelines.
9. Assures the accuracy of case report forms (CRF) and that reporting time requirements are met.

Administrative
1. Supervises study personnel within the scope of state regulatory agencies with regard to managing/delegating licensed personnel.
2. Participates in the identification of relevant new studies.
3. Prepares initial application to IRB for approval to conduct study according to IRB guidelines and subsequent amendments.
4. Coordinates all site visits, which may include pre-study, initiation and closeout visits with key personnel.
5. Identifies all tasks that need to be performed by study personnel and delegates tasks according to state licensure regulations. Meets, where applicable, with ancillary departments to determine the willingness/ability of those departments to participate in study. Determines staffing requirements and qualifications of staff to conduct study.
6. Maintains accurate and essential documents as required by FDA, IRB, sponsor and other regulatory agencies or funding agency.
7. Trains staff and plans staff assignments in conducting studies.
8. Submits to PI and IRB the initial investigator's brochure and subsequent modifications.
9. Coordinates monitoring visits with clinical research associate (CRA)/sponsor monitor and acts as liaison with PI and monitor/sponsor.
10. Coordinates closeout of study with key personnel.
11. Prepares/assists with grant application.
12. Prepares abstracts as required by department.
13. Develop positive working relationships with ancillary departments to ensure smooth study progress.
14. Acts as liaison between principal investigator and the IRB.
15. Prepares advertising for recruitment of subjects (requires prior IRB approval) per department requirements.
16. Keeps abreast of FDA, IRB and other regulatory agency compliance requirements and subject safety issues.
17. Maintains data integrity.
18. Monitors research project activity to ensure compliance with appropriate regulatory agency requirements/regulations and protocol design.
19. Manages study supplies where applicable.
20. Manages record retention according to FDA, IRB and other regulatory agency and sponsor guidelines.
21. Assists in preparing for FDA and internal audits.
22. Interviewing, training, supervising and evaluating assigned personnel within the scope of professional practice.
23. Support research and education efforts and opportunities for staff by remaining informed of current research that affects their practice.
24. Developing and implementing operational systems to improve departmental efficiency
25. Performs other functionally related duties as assigned.

Financial
1. Prepares study budget as required. Works closely with the Research Administration Business Office and grants management specialist assuring all required documents are submitted in application.
2. Collaborates with investigator and business manager to determine economic feasibility of proposed studies.
3. Reviews and approves study invoices for payment. Determines all invoices are received for services provided by ancillary staff.
4. Meets regularly with their assigned Grants Management Specialist to review budget.

Required Qualifications
Bachelor's Degree in a health-related field (i.e., Nursing, Nutrition, Social Work or other Health Profession).
Knowledgeable of all regulatory requirements in conducting research involving human subjects.
Three years combined clinical research and management experience.
Outstanding interpersonal, written and verbal communication skills.
Good organization and problem solving skills.
Proficiency in personal computers and various software and database applications.
Current CPR card if providing direct patient care.
Knowledgeable of good clinical practices (GCP) in research.
Ability to work independently.
Good motivational skills.
Excellent management skills.
Note: May be additional requirements including competencies as required by the department that will be indicated on the position posting.

Preferred Qualifications
Master's degree in health or related field.
Certified clinical research coordinator (CCRC).
Experience in Institutional Review Board (IRB) process.
Experience in budget preparation.
Knowledgeable in area of department specialty.

I have read and understand the job description and qualifications for the position for which I have applied.

Applicant Signature

Date Signed