Clinical Research Specialist (On-Site)

About the role

Careers in Clinical Research at UHC United Hospital Center offer a unique opportunity to contribute to the advancement of medical knowledge and improve patient care. Our team is dedicated to conducting high-quality clinical trials and ensuring the safety and well-being of our research participants.

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.
• 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.
• Captures and analyzes data from clinical trials and reports findings accurately.
• Coordinates care management of research patients undergoing treatment in the suite.

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.

Preferred Qualifications

• Two (2) years research experience.

Core Duties and 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.
• Captures and analyzes data from clinical trials and reports findings accurately.
• Coordinates care management of research patients undergoing treatment in the suite.

Physical Requirements

• 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.
• Sometimes requires heavy lifting (patient assistance).
• Occasionally moves equipment.

Skills and Abilities

• 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.