Clinical Research Specialist

Clinical Trials Coordinator

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.

Minimum Qualifications

Education, Certification, and/or Licensure:

• 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.
• Experience: Three (3) years clinical experience.

Preferred Qualifications

Experience: Two (2) years 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.

• 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.

• 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.

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.

• Normal clinical environment. 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.

Skills and Abilities

1. Excellent written, oral, and interpersonal communication skills. Ability to speak effectively before groups. Ability to write routine reports and correspondence.

2. High degree of computer literacy, MS Office products.

3. 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.

4. Analytical skills include the technical aspects of gathering data for purposes of study-related activities.

5. Careful attention to detail.

6. Excellent organization skills and ability to prioritize a variety of tasks. Excellent time and project management skills.

7. 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.

Additional Job Description:

Scheduled Weekly Hours: 40

Shift: Exempt/Non-Exempt: United States of America (Exempt)

Company: WVUH West Virginia University Hospitals

Cost Center: 118 WVUH HVI Clinic

Address: 1 Medical Center Drive Morgantown West Virginia

Equal Opportunity Employer

West Virginia University Health System and its subsidiaries (collectively "WVUHS") is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. WVUHS strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, past, current, or prospective service in the uniformed services, genetic information, or any other characteristic protected under applicable federal, state, or local law. All WVUHS employees, other workers, and representatives are prohibited from engaging in unlawful discrimination. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and termination of employment.