POSITION DESCRIPTION

JOB TITLE & CODE:	Research Specialist (88162)
DEPARTMENT:	Heart and Vascular Institute
REPORTS TO:	Director
FLSA STATUS:	Exempt

POSITION SUMMARY: 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. As the primary resource for the protocols, the Clinical Trials Research Specialist will act as a liaison between the investigators, primary care providers, the Institutional Review Board (IRB), the sponsor, study subjects and study team. Along with the investigator, the CTRS will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the CTRS will assist the Primary Investigator with all aspects of data and source documentation, adverse experience reporting and maintenance of complete regulatory files. In additionally the CTRS will be responsible for patient education, case management with follow up phone calls, tracking of costs per case and clinical outcomes.

MINIMUM QUALIFICATIONS:
EDUCATION, CERTIFICATION, AND/OR LICENSURE:
1.	Bachelor’s degree in a scientific, healthcare, or other related field.
2.	Obtain certification in Basic Life Support within 30 days of hire date.
3.	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.
EXPERIENCE:
1.	Three (3) years of general research experience.

PREFERRED QUALIFICATIONS:
EXPERIENCE:
1.	Five (5) years of experience in clinical setting.
2.	Licensed Practical Nurse, Medical Assistant, or other relevant medical education, certification, or licensure.

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.	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.
2.	Prepares protocols and ongoing amendments for initial IRB submission including preparation of IRB Protocol Statement, Abstract, Consent and Assent Forms and Discussion.
3.	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.
4.	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.
5.	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.
6.	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.
7.	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.
8.	Clinical coordination of protocols and clinical trials, including scheduling follow up visits and testing, assess subject response and review of laboratory data.
9.	Provides quality assurance for the clinical protocols and investigations, ensuring protocol guidelines are followed.
10.	Explores and evaluates opportunities for federal, state, private and institutional funding and external presentations, including grant writing and submission.
11.	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.
1.	This position requires manual dexterity used in operating office equipment.
2.	Requires standing and bending in the assessment and treatment of patients.
3.	Prolonged periods of sitting and the ability to walk moderate distances.
4.	Some manual work may be included.
5.	Occasional heavy lifting (patient assistance) and the ability to move equipment.

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 environment. There is patient contact and potential 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.	Prior clinical research and trial experience desired.
2.	Excellent written, oral, and interpersonal communication skills.
3.	High degree of computer literacy, MS Office products.
4.	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.
5.	Ability to work independently.
6.	Analytical skills include the technical aspects of gathering data for purposes of study-related activities.
7.	Careful attention to detail.
8.	Excellent organization skills and ability to prioritize a variety of tasks.

Date Reviewed/Revised:  February 2019