Ophthalmic Clinical Research Assistant

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Incumbent, with supervision/direction from the manager will serve as the research assistant for a variety of clinical trials and/or studies.
The major purpose of this position is to provide support to the clinical trials coordinator(s) of all assigned clinical trials and studies in which the department is participating.
In addition, the incumbent will perform all usual and necessary diagnostic testing required by those clinical trials to the ability of their level of skills and/or certification.
This position will require incumbent to recruit patients for assigned studies which will include chart searches, advertisement, referrals and other means as necessary and directed.
Incumbent will work directly with Administrator in fiscal matters and with various internal physicians, external physicians, internal regulation agencies, external regulation agencies, and a variety of patients.
Incumbent, with supervision/direction from the manager will serve as the research assistant for a variety of clinical trials and/or studies.
The major purpose of this position is to provide support to the clinical trials coordinator(s) of all assigned clinical trials and studies in which the department is participating.
In addition, the incumbent will perform all usual and necessary diagnostic testing required by those clinical trials to the ability of their level of skills and/or certification.
This position will require incumbent to recruit patients for assigned studies which will include chart searches, advertisement, referrals and other means as necessary and directed.
Incumbent will work directly with Administrator in fiscal matters and with various internal physicians, external physicians, internal regulation agencies, external regulation agencies, and a variety of patients.
MINIMUM QUALIFICATIONS : EDUCATION, CERTIFICATION, AND/OR LICENSURE: 1.
High school diploma or equivalent AND two (2) years clinical research experience.
2.
Phlebotomy Certification required after one (1) year 3.
Clinical Research Coordinator Required after two (2) years PREFERRED QUALIFICATIONS : EDUCATION, CERTIFICATION, AND/OR LICENSURE: 1.
Current Certified Ophthalmic Assistant (COA) certification 2.
Current Certified Ophthalmic Technician (COT) certification 3.
Certified Ophthalmic Medical Technologist (COMT) certification EXPERIENCE: 1.
One year of clinical or basic science research experience CORE DUTIES AND RESPONSIBILITIES: The statements described here are intended to describe the general nature of work being performed by people assigned to this position.
They are not intended to be constructed as an all-inclusive list of all responsibilities and duties.
Other duties may be assigned.
1.
This position works in the Department of Ophthalmology and in the Department of Otolaryngology.
All positions will be required to work with Physicians from both departments.
This will require members of the team to walk over to the POC to see those ENT patients when needed.
2.
Classify and maintain all study records within the department to ensure that records are in compliance with study guidelines, confidentiality guidelines (both corporate and/or federal).
3.
Familiarize and become highly knowledgeable with all study/clinical trials protocols currently assigned to the department.
4.
Assists Clinical Trials Coordinator with the conduct of clinical research studies under the supervision of a principal investigator.
5.
Participates in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data.
6.
Assists in gathering documentation of patient visits and assessments according to protocol.
7.
Demonstrates competency in technical and clinical skills, completes skills, and correctly performs these skills daily as required.
8.
Administers medications by all acceptable routes, as ordered by the physician and according to accepted policy and procedure 9.
Completely and accurately transcribes and carries out physician orders.
10.
Performs filing and data entry as needed to keep all research records and regulatory files up to date.
BCVA (Best Corrected visual Acuity) with Loose Lens or Phoropter refraction to check vision.
Tonometer - To measure eye pressures.
iCare Tonometer – To measure eye pressure.
Goldman Applanation – To measure eye pressure.
Dilation of eyes prior to required Ophthalmic exams.
Visual Field Testing – Check the field of vision of patients.
Biometry – Measuring the power of the cornea and the length of the eye itself for the IOL Master.
IRIS imaging – Obtain photos of the iris using several types of testing equipment, Heidelberg, iCam, and Nikon SLR Digital Camera Draw labs for Genetic Testing 11.
Carries out ophthalmic testing and assessments as required by protocol and as assigned by designated investigator.
12.
Work collaboratively with investigators and study coordinators for study-specific training and communication related to possible or already accrued study participants.
13.
Determines the need for study-specific training for study team members, patients and/or family members regarding research study requirements to ensure that all relevant individuals adequately understand key elements of the study.
14.
Independently participates in activities to increase knowledge base and performance.
15.
Ensures compliance with WVU Institutional Review Board, Good Clinical Practice (GCP Training) guidelines and federal regulations related to clinical research.
Collaborative Institutional Training Initiative (CITI Training).
ONCORE Training.
16.
Maintains timely and accurate reports of adverse events and protocol deviations to assure proper IRB and/or sponsor notification.
17.
Maintains all record of patient visits, compliance and schedules for all patients enrolled into all clinical trials/studies.
18.
Maintains timely, study-specific documentation that reflects an accurate, complete, and legible record of study activities.
19.
Associated clerical duties as assigned and necessary for each study/trial assigned.
20.
Attendance of all appropriate training seminars is required by study/trial agency.
21.
Participates in the patient recruitment and enrollment efforts 22.
Weekly chart review to help gather potential study patients that will then be discussed with each individual Physician to determine if those patients are eligible for each study 23.
Ability to embrace a fast paced and dynamic environment where daily responsibilities could change frequently.
24.
Advanced understanding of HIPAA regulations.
25.
Excellent decision-making skills.
26.
Lead and participate in conferences related to the projects and/or their progress.
Present research findings in meetings, conferences, and professional societies.
27.
Provide data support for any study audit, internal/sponsored/FDA/etc.
And be proficient with the data on your studies.
28.
Perform literature reviews and create bibliographies for reports and papers.
29.
Responsible for study patient payments.
Setting up Clin Cards for patients and/or making sure patients are registered in the pre-paid card program, making sure study payments are made to the study patient in a timely manner with the correct amount for payment for each visit.
PHYSICAL REQUIREMENTS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1.
This position requires manual dexterity used in operating office equipment; requires standing and bending in the assessment and treatment of patients; prolonged periods of sitting and the ability to walk moderate distances.
Some manual work may be included; occasional heavy lifting (patient assistance) and the ability to move equipment.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
WORKING ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1.
Work environment is in a normal, clinical office environment.
Incumbent is likely to come in contact with patients having communicable disease (URI, HIV, Hepatitis B, TB, usual childhood diseases, etc.
) The presence of blood and specimen care and processing is a routine part of this environment.
SKILLS AND ABILITIES: 1.
Planning skills in scheduling of patients, physicians, site visitors and facility usage are critical.
Analysis of protocols, feasibility of studies based on patient populations, financial considerations, facility capabilities, technical support and other support systems is imperative.
2.
Analytical skills include the technical aspects of gathering data for purposes of process improvement and aid in pursuing the courses of action directed by the physician and/or clinic manager required for patient care activities.
3.
Ability to work independently.
4.
Excellent interpersonal skills are required to work with study participants and working as a member of a highly integrated team.
5.
Exceptional oral and written communication skills 6.
Careful attention to detail.
7.
High degree of computer literacy, MS Office products.
8.
Excellent organization skills and ability to prioritize a variety of tasks MINIMUM QUALIFICATIONS : EDUCATION, CERTIFICATION, AND/OR LICENSURE: 1.
High school diploma or equivalent AND two (2) years clinical research experience.
2.
Phlebotomy Certification required after one (1) year 3.
Clinical Research Coordinator Required after two (2) years PREFERRED QUALIFICATIONS : EDUCATION, CERTIFICATION, AND/OR LICENSURE: 1.
Current Certified Ophthalmic Assistant (COA) certification 2.
Current Certified Ophthalmic Technician (COT) certification 3.
Certified Ophthalmic Medical Technologist (COMT) certification EXPERIENCE: 1.
One year of clinical or basic science research experience CORE DUTIES AND RESPONSIBILITIES: The statements described here are intended to describe the general nature of work being performed by people assigned to this position.
They are not intended to be constructed as an all-inclusive list of all responsibilities and duties.
Other duties may be assigned.
1.
This position works in the Department of Ophthalmology and in the Department of Otolaryngology.
All positions will be required to work with Physicians from both departments.
This will require members of the team to walk over to the POC to see those ENT patients when needed.
2.
Classify and maintain all study records within the department to ensure that records are in compliance with study guidelines, confidentiality guidelines (both corporate and/or federal).
3.
Familiarize and become highly knowledgeable with all study/clinical trials protocols currently assigned to the department.
4.
Assists Clinical Trials Coordinator with the conduct of clinical research studies under the supervision of a principal investigator.
5.
Participates in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data.
6.
Assists in gathering documentation of patient visits and assessments according to protocol.
7.
Demonstrates competency in technical and clinical skills, completes skills, and correctly performs these skills daily as required.
8.
Administers medications by all acceptable routes, as ordered by the physician and according to accepted policy and procedure 9.
Completely and accurately transcribes and carries out physician orders.
10.
Performs filing and data entry as needed to keep all research records and regulatory files up to date.
BCVA (Best Corrected visual Acuity) with Loose Lens or Phoropter refraction to check vision.
Tonometer - To measure eye pressures.
iCare Tonometer – To measure eye pressure.
Goldman Applanation – To measure eye pressure.
Dilation of eyes prior to required Ophthalmic exams.
Visual Field Testing – Check the field of vision of patients.
Biometry – Measuring the power of the cornea and the length of the eye itself for the IOL Master.
IRIS imaging – Obtain photos of the iris using several types of testing equipment, Heidelberg, iCam, and Nikon SLR Digital Camera Draw labs for Genetic Testing 11.
Carries out ophthalmic testing and assessments as required by protocol and as assigned by designated investigator.
12.
Work collaboratively with investigators and study coordinators for study-specific training and communication related to possible or already accrued study participants.
13.
Determines the need for study-specific training for study team members, patients and/or family members regarding research study requirements to ensure that all relevant individuals adequately understand key elements of the study.
14.
Independently participates in activities to increase knowledge base and performance.
15.
Ensures compliance with WVU Institutional Review Board, Good Clinical Practice (GCP Training) guidelines and federal regulations related to clinical research.
Collaborative Institutional Training Initiative (CITI Training).
ONCORE Training.
16.
Maintains timely and accurate reports of adverse events and protocol deviations to assure proper IRB and/or sponsor notification.
17.
Maintains all record of patient visits, compliance and schedules for all patients enrolled into all clinical trials/studies.
18.
Maintains timely, study-specific documentation that reflects an accurate, complete, and legible record of study activities.
19.
Associated clerical duties as assigned and necessary for each study/trial assigned.
20.
Attendance of all appropriate training seminars is required by study/trial agency.
21.
Participates in the patient recruitment and enrollment efforts 22.
Weekly chart review to help gather potential study patients that will then be discussed with each individual Physician to determine if those patients are eligible for each study 23.
Ability to embrace a fast paced and dynamic environment where daily responsibilities could change frequently.
24.
Advanced understanding of HIPAA regulations.
25.
Excellent decision-making skills.
26.
Lead and participate in conferences related to the projects and/or their progress.
Present research findings in meetings, conferences, and professional societies.
27.
Provide data support for any study audit, internal/sponsored/FDA/etc.
And be proficient with the data on your studies.
28.
Perform literature reviews and create bibliographies for reports and papers.
29.
Responsible for study patient payments.
Setting up Clin Cards for patients and/or making sure patients are registered in the pre-paid card program, making sure study payments are made to the study patient in a timely manner with the correct amount for payment for each visit.
PHYSICAL REQUIREMENTS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1.
This position requires manual dexterity used in operating office equipment; requires standing and bending in the assessment and treatment of patients; prolonged periods of sitting and the ability to walk moderate distances.
Some manual work may be included; occasional heavy lifting (patient assistance) and the ability to move equipment.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
WORKING ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1.
Work environment is in a normal, clinical office environment.
Incumbent is likely to come in contact with patients having communicable disease (URI, HIV, Hepatitis B, TB, usual childhood diseases, etc.
) The presence of blood and specimen care and processing is a routine part of this environment.
SKILLS AND ABILITIES: 1.
Planning skills in scheduling of patients, physicians, site visitors and facility usage are critical.
Analysis of protocols, feasibility of studies based on patient populations, financial considerations, facility capabilities, technical support and other support systems is imperative.
2.
Analytical skills include the technical aspects of gathering data for purposes of process improvement and aid in pursuing the courses of action directed by the physician and/or clinic manager required for patient care activities.
3.
Ability to work independently.
4.
Excellent interpersonal skills are required to work with study participants and working as a member of a highly integrated team.
5.
Exceptional oral and written communication skills 6.
Careful attention to detail.
7.
High degree of computer literacy, MS Office products.
8.
Excellent organization skills and ability to prioritize a variety of tasks Additional Job Description: Scheduled Weekly Hours: 40 Shift: Days (United States of America) Exempt/Non-Exempt: United States of America (Non-Exempt) Company: WVUH West Virginia University Hospitals Cost Center: 8140 WVUH Ophthalmology Address: 1 Medical Center Drive Morgantown West Virginia