Clinical Specialist Jobs

About The Position

Requirements

• 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.
• Three (3) years clinical experience.
• 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.
• Analysis of protocols, feasibility of studies based on patient populations, financial considerations, facility capabilities, technical support and other support systems is imperative.
• 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.

Nice To Haves

• 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.
• Two (2) years research experience.

Responsibilities

• 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.