Clinical Research Study Assistant
Optima Dermatology, Youngstown, OH, United States
Clinical Research Study Assistant
Boardman, OH
Multi-site Dermatology Group Seeks Medical Receptionist / Clinical Research Study Assistant
Optima Dermatology is recruiting an experienced full time Medical Receptionist / Clinical Research Study Assistant to join our growing Dermatology and Medical Aesthetics group in Boardman, OH.
Position Summary
The Medical Receptionist (MR)/Clinical Research Study Assistant (CRSA) is responsible for a variety of activities in support of clinical research studies. The MR-CRSA works closely with and carries out the directives of the Sub-Investigator in all aspects of the care and treatment of clinical research subjects in compliance with study protocols throughout the research study. The MR-CRSA is responsible for his/her delegated tasks as it relates to but is not limited to, the following areas: protocol requirements, patient visits (paper and electronic); laboratory and test article. The MR-CRSA must have knowledge of protocol design and Good Clinical Practices (GCP) as set forth by the Federal Regulations and International Conference of Harmonization (ICH) Guidelines for protecting human subjects and conducting clinical research. Knowledge of the International Air Transport Association (IATA) regulations for the transportation of Dangerous Goods is also necessary. Under the direction of the Sub-Investigator, the MR-CRSA will help ensure protocol compliance, Investigational Article accountability, and proper follow-up during the clinical trial.
Typical Physical Demands:
Physically capable of lifting, moving, or transporting supplies, medical records, and equipment within reasonable weight limits. Physically capable of reading and reviewing handwritten chart notations. Physically capable of bending, sitting, or standing for extended periods of time, reaching, and climbing to retrieve or store medical records. Physically capable of manually entering data into an electronic database using a keyboard. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Typical Work Conditions:
Fast-paced clinical research center environment. Must be able to adjust and adapt to changing conditions.
Qualifications, Requirements, and Education:
Minimum: High School Diploma. Preferred: Associate degree in a medical-related field and one-year clinical research experience.
Essential Skills:
Maintain the highest level of professional conduct in the presence of investigators, subjects, research staff, sponsors, etc.
Able to perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study-specific protocols
Computer skills with the capability of using clinical trial databases, electronic data capture, Microsoft Word Office
Ability to communicate clearly using excellent verbal and written communications skills
Possess exceptional organizational and prioritization skills as demonstrated by planning objectives and strategies to ensure that the process/requirements for the flow of clinical research information are optimized, such as charting is completed accurately and thoroughly and ready for EDC processing within 48 hours of the patient visit.
Ability to problem-solve, prioritize quickly and accurately, and multi-task to facilitate workflow
Ability to work independently in a fast-paced environment, as well as work collaboratively as a team
Possess and utilize excellent interpersonal skills with patients, staff, and others
Meticulous and detail-oriented
Ability to perform Phlebotomy, Urinary Pregnancy Test
Ensure the proper collection, processing, and shipment of biospecimens (e.g., centrifuge, freezing, refrigeration.
Duties and Responsibilities:
Medical Receptionist:
Welcomes and receives patients/visitors to Optima Research by greeting them with a warm, pleasant affect
Provides study candidates and participants with appropriate forms for their visit
Gathers information from study candidates/participants upon arrival using the appropriate form for their visit
Notifies clinical staff when study candidates/participants are ready to be seen for their appointment
Pulls and prepares study participant binders for scheduled visits the day prior
In collaboration with the Clinical Research Coordinators, schedules study participant appointments within the visit window as designated by the study protocol in CRIO
Provides study participants with appropriate compensation at the conclusion of each study visit, obtaining participant signature for cash distribution and maintaining stipend cash log
Answers phones using professional telephone etiquette
Knowledgeable of phone system and routes calls appropriately or takes detailed messages if call recipient is unavailable, documents messages in CRIO
Notifies subjects of upcoming visits the day before
Responds to and sends faxes
Distributes incoming faxes to the appropriate recipient
Knowledgeable in using front office equipment, such as copier, computer, etc.
Complies with HIPPA guidelines, protecting and respecting the privacy of all patient information and records
Stores all files in a permanent, dry, and safe location
Maintains a cooperative, helpful, and pleasant affect, creating and/or contributing to an atmosphere of collaboration and team cohesiveness
Maintains neatness of the front office, patient reception area, and patient lounge
Cleans surfaces and chairs of patient reception area, patient lounge, and patient treatment rooms at the end of each business day with germicidal wipes
Assists clinical research coordinators and other staff as needed
Assists in the day-to-day operations, as needed and as assigned
Clinical Trial Process:
Assists in facilitating the daily clinical trial activities
Reviews and comprehends each protocol
Thoroughly and accurately completes study participant logs, keeping them current
Assists in screening, recruiting, enrolling, and maintaining research participants
Ensures adherence to protocol requirements
Knowledgeable of the storage/temperature requirements for all assigned study medications stored on site
Ensures appropriate specimen collection, processing, and shipment per study protocol
Communicates lab alerts to appropriate persons in a timely manner.
Maintains study source documents in the subject chart (e.g., medical history, laboratory reports, ECG, etc.)
Ensure that all daily subject visit requirements are completed prior to daily departure (i.e., rotating late-day schedule)
Administers questionnaires/diaries per protocol
Other:
Completes Continuing Education/In-service Education Requirements in the designated timeframe
Adheres to Optima Policies and Procedures, Employee Guidebook, and Standard Operating Procedures
Proper archiving of all documents and supplies at study close-out (i.e., breaking down study charts)
Assisting in maintaining IP temperature (ambient and refrigerated) and reporting any excursion that may occur
Boardman, OH
Multi-site Dermatology Group Seeks Medical Receptionist / Clinical Research Study Assistant
Optima Dermatology is recruiting an experienced full time Medical Receptionist / Clinical Research Study Assistant to join our growing Dermatology and Medical Aesthetics group in Boardman, OH.
Position Summary
The Medical Receptionist (MR)/Clinical Research Study Assistant (CRSA) is responsible for a variety of activities in support of clinical research studies. The MR-CRSA works closely with and carries out the directives of the Sub-Investigator in all aspects of the care and treatment of clinical research subjects in compliance with study protocols throughout the research study. The MR-CRSA is responsible for his/her delegated tasks as it relates to but is not limited to, the following areas: protocol requirements, patient visits (paper and electronic); laboratory and test article. The MR-CRSA must have knowledge of protocol design and Good Clinical Practices (GCP) as set forth by the Federal Regulations and International Conference of Harmonization (ICH) Guidelines for protecting human subjects and conducting clinical research. Knowledge of the International Air Transport Association (IATA) regulations for the transportation of Dangerous Goods is also necessary. Under the direction of the Sub-Investigator, the MR-CRSA will help ensure protocol compliance, Investigational Article accountability, and proper follow-up during the clinical trial.
Typical Physical Demands:
Physically capable of lifting, moving, or transporting supplies, medical records, and equipment within reasonable weight limits. Physically capable of reading and reviewing handwritten chart notations. Physically capable of bending, sitting, or standing for extended periods of time, reaching, and climbing to retrieve or store medical records. Physically capable of manually entering data into an electronic database using a keyboard. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Typical Work Conditions:
Fast-paced clinical research center environment. Must be able to adjust and adapt to changing conditions.
Qualifications, Requirements, and Education:
Minimum: High School Diploma. Preferred: Associate degree in a medical-related field and one-year clinical research experience.
Essential Skills:
Maintain the highest level of professional conduct in the presence of investigators, subjects, research staff, sponsors, etc.
Able to perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study-specific protocols
Computer skills with the capability of using clinical trial databases, electronic data capture, Microsoft Word Office
Ability to communicate clearly using excellent verbal and written communications skills
Possess exceptional organizational and prioritization skills as demonstrated by planning objectives and strategies to ensure that the process/requirements for the flow of clinical research information are optimized, such as charting is completed accurately and thoroughly and ready for EDC processing within 48 hours of the patient visit.
Ability to problem-solve, prioritize quickly and accurately, and multi-task to facilitate workflow
Ability to work independently in a fast-paced environment, as well as work collaboratively as a team
Possess and utilize excellent interpersonal skills with patients, staff, and others
Meticulous and detail-oriented
Ability to perform Phlebotomy, Urinary Pregnancy Test
Ensure the proper collection, processing, and shipment of biospecimens (e.g., centrifuge, freezing, refrigeration.
Duties and Responsibilities:
Medical Receptionist:
Welcomes and receives patients/visitors to Optima Research by greeting them with a warm, pleasant affect
Provides study candidates and participants with appropriate forms for their visit
Gathers information from study candidates/participants upon arrival using the appropriate form for their visit
Notifies clinical staff when study candidates/participants are ready to be seen for their appointment
Pulls and prepares study participant binders for scheduled visits the day prior
In collaboration with the Clinical Research Coordinators, schedules study participant appointments within the visit window as designated by the study protocol in CRIO
Provides study participants with appropriate compensation at the conclusion of each study visit, obtaining participant signature for cash distribution and maintaining stipend cash log
Answers phones using professional telephone etiquette
Knowledgeable of phone system and routes calls appropriately or takes detailed messages if call recipient is unavailable, documents messages in CRIO
Notifies subjects of upcoming visits the day before
Responds to and sends faxes
Distributes incoming faxes to the appropriate recipient
Knowledgeable in using front office equipment, such as copier, computer, etc.
Complies with HIPPA guidelines, protecting and respecting the privacy of all patient information and records
Stores all files in a permanent, dry, and safe location
Maintains a cooperative, helpful, and pleasant affect, creating and/or contributing to an atmosphere of collaboration and team cohesiveness
Maintains neatness of the front office, patient reception area, and patient lounge
Cleans surfaces and chairs of patient reception area, patient lounge, and patient treatment rooms at the end of each business day with germicidal wipes
Assists clinical research coordinators and other staff as needed
Assists in the day-to-day operations, as needed and as assigned
Clinical Trial Process:
Assists in facilitating the daily clinical trial activities
Reviews and comprehends each protocol
Thoroughly and accurately completes study participant logs, keeping them current
Assists in screening, recruiting, enrolling, and maintaining research participants
Ensures adherence to protocol requirements
Knowledgeable of the storage/temperature requirements for all assigned study medications stored on site
Ensures appropriate specimen collection, processing, and shipment per study protocol
Communicates lab alerts to appropriate persons in a timely manner.
Maintains study source documents in the subject chart (e.g., medical history, laboratory reports, ECG, etc.)
Ensure that all daily subject visit requirements are completed prior to daily departure (i.e., rotating late-day schedule)
Administers questionnaires/diaries per protocol
Other:
Completes Continuing Education/In-service Education Requirements in the designated timeframe
Adheres to Optima Policies and Procedures, Employee Guidebook, and Standard Operating Procedures
Proper archiving of all documents and supplies at study close-out (i.e., breaking down study charts)
Assisting in maintaining IP temperature (ambient and refrigerated) and reporting any excursion that may occur