Job Description

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.
• 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

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