Clinical Research Specialist

WVU Medicine

19h•Onsite

About The Position

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.

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.
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.

Nice To Haves

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.