Research Study Coordinator- Clinical Trails Hurwitz

Supports, and is responsible for incorporating into job performance, the Frederick Health (FH) mission, vision, core values and customer service philosophy and adheres to the FH Compliance Program, including following all regulatory requirements and the FH Standards of Behavior.

Under the direction of the Clinical Manager, coordinates the research care delivery with the principal investigator, and other members of the clinical research team. Maintains detailed knowledge of all active clinical trials studies and coordinates workflows and processes that provide effective patient management. Assists the clinicians in patient study visits and study procedure. Responsible for the coordination and maintenance of regulatory documentation, electronic study data, site registration status, and product inventory.

Works closely with the research clinicians in reviewing potential new studies, initiating new approved studies, and patient screening for potential eligibility. Represents the Clinical Trials department at IRB and investigator meetings. Coordinates invoicing and revenue capture according to study contracts. Actively participates in performance and quality improvement activities within the Clinical Trials department.

• Maintains detailed knowledge of clinical trials studies for effective patient coordination.
• Assists research clinicians with patient screening, on-study treatment visits, off-treatment/survival follow-up.
• Coordinates patient consenting process, patient eligibility, and enrollment tracking and documentation.
• Responsible for the electronic submission of patient registration/randomization.
• Maintains inventory of investigation product.
• Performs phlebotomies as needed.
• Reviews lab results for patients on study treatment to determine study treatment dose changes as necessary.
• Coordinates visit specific study lab kits as necessary and manage lab kit inventory and supplies for each study.
• Coordinates study specific blood specimen and tumor specimen processing, storage, and shipment.
• Responsible for timely and accurate data submissions, data queries, follow-up forms, and case report forms.
• Coordinates with Clinical Research Monitors for on-site data audits.
• Processes all IND Safety Alerts on a monthly basis.
• Maintains site registration status.
• Collaborates with physicians and multidisciplinary medical teams to establish workflows and protocols that align with study requirements.
• Supports and participates in performance and quality improvement activities within the Clinical Trials department.
• Responsible for invoicing and revenue capture as outlined in study contracts.
• Participates in community events related to the Frederick Health Clinical Trials Program.

• Detailed knowledge of clinical trials studies, protocols, and policies.
• Strong organizational skills.
• Able to prioritize and manage multiple tasks.
• Excellent written and verbal communication skills.
• Excellent customer service skills.
• Able to assess and care for patients with special needs with respect to cultural, ethical, and religious differences and physical abilities.
• Able to maintain a high level of confidentiality related to employee and patient information.

• A detailed knowledge of research protocols and regulations. At least three years of experience in a Clinical Trials setting required.
• Oncology experience highly desirable.
• A Bachelor’s degree in a healthcare or research related field preferred.
• Excellent written and verbal communication skills. Detail oriented.
• Strong organizational skills and ability to prioritize and manage multiple tasks.
• Able to maintain a high level of confidentiality related to employee and…