Clinical Research Specialist
WVUH West Virginia University Hospitals
Behavioral Health Market Context
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Qualifications
- •Associate's degree in nursing AND current Registered Nurse license issued by the state in which services will be provided or current multi-state Registered Nurse license through the enhanced Nurse Licensure Compact ( eNLC )
- •OR an advanced degree (i.e
- •MA, MD, PhD) in a scientific, healthcare, or other related field
- •Obtain certification in Basic Life Support within 30 days of hire date
- •Obtain certification as a Research Professional through the Society of Clinical Research Associates (SoCRA) OR the Association of Clinical Research Professionals (ACRP) with three years of hire date into Clinical Research Specialist role
- •Three (3) years clinical experience
- •Two (2) years research experience
- •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
- •Excellent written, oral, and interpersonal communication skills
- •Ability to speak effectively before groups
- •Ability to write routine reports and correspondence
- •High degree of computer literacy, MS Office products
- •Planning skills in scheduling of patients, physicians, site visitors and facility usage are critical
- •Analytical skills include the technical aspects of gathering data for purposes of study-related activities
- •Careful attention to detail
- •Excellent organization skills and ability to prioritize a variety of tasks
- •Excellent time and project management skills
- •Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility and provides administrative and regulatory management of protocols and clinical trials ensuring compliance with WVU IRB, GCP guidelines and code of federal regulations
- •19 more items(s)
Responsibilities
- •Coordinates and manages clinical trials/protocols within the Department ensuring adherence to protocol requirements and regulatory guidelines
- •Manages the implementation, system administration and maintenance of patient databases including but not limited to the collection, analysis, and reporting of patient outcomes data
- •They are not intended to be constructed as an all-inclusive list of all responsibilities and duties
- •Prepares protocols and ongoing amendments for initial IRB submission including preparation of IRB Protocol Statement, Abstract, Consent and Assent Forms and Discussion
- •Develops a mechanism for subject recruitment and ongoing communications with the primary care physician and nursing staff and serves as a liaison between the WVU IRB, PI and Sponsor or Sponsor’s representative, as appropriate
- •Prepares Annual Protocol Reviews and Study Summaries for submission to WVU IRB
- •Prepares and reviews clinical trial budgets
- •Reviews and submits clinical Trial Agreements (including clinical trial budgets) to the WVU Office of Sponsored Programs
- •Coordinates Protocol Review Committee Meetings, and attends other study related meetings as necessary, to ensure peer review of all protocols under consideration for IRB submission
- •Reviews with the PI the inclusion/exclusion criteria, overall structure, and requirements of each protocol and the protocols summary sheet and informed consent form for accuracy and clarity
- •Reviews the protocol, informed consent form, and follow-up procedures with potential study subjects and ensures the informed consent is signed before subjects are screened and enrolled
- •Clinical coordination of protocols and clinical trials, including scheduling follow up visits and testing, assess subject response and review of laboratory data
- •Provides quality assurance for the clinical protocols and investigations, ensuring protocol guidelines are followed
- •Explores and evaluates opportunities for federal, state, private and institutional funding and external presentations, including grant writing and submission
- •Coordinates care management of research patients undergoing treatment in the suite
- •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
- •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
- •There is patient contact and potential to come in contact with patients having communicable disease
- •The presence of blood and specimen care and processing is a routine part of this environment
- •Analysis of protocols, feasibility of studies based on patient populations, financial considerations, facility capabilities, technical support and other support systems is imperative
- •19 more items(s)
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