Clinical Research Supervisor

Description

The Clinical Research Supervisor serves as the primary point of contact for the clinical trials unit. The Clinical Research Supervisor works closely with the Clinical Research Manager and the physicians to ensure the safety and well-being of the study patient is protected. Clinical Research Supervisor is expected to provide supervisory oversight for study onboarding and management, directs the activities of the Clinical Trials team as needed, and performs all clinical trials billing.

Essential functions:

Study management: including onboarding of new studies (PSV’s, contract, and budget management), source creation (eCRF and other), scheduling (physician and clinic staffing, patient visit windows, tracking patient appointments), all calibration and monitoring updates (all equipment), 1572, CV, and GCP management.

Supervisory responsibilities: oversight of clinical trials staff, lead weekly clinical trials meetings, weekly meetings with clinic supervisors and Director of Operations, authoring and outlining processes and clinical trials SOPs, determine tasks for the CTU staff, as needed.

Study billing responsibilities: outlining invoicing guidelines (invoiceable, FE coverage, cab rides, etc.), requesting and tracking the receipt of monthly patient stipends, tracking end of day charge transfers, tracking all non-automatic invoicing (QuickBooks), invoice creation and management for select studies, and tracking all EDC payments made to the site.

Serve as a back-up for studies as needed. Including: Study recruiting activity (pre-screening, screening, and recruiting patients). Obtaining informed consent per ICH/GCP and site SOPs. Interviewing and collecting data from study patients. Coordination of study visits, including AE’s, ConMeds, IOP. Scheduling subject visits as needed.

Obtaining subject vital statistics (including height, weight, BMI, pulse, respiratory rate, blood pressure, etc.) and ECGs. Dispensing/collecting study medication and providing accurate Investigational Product accountability

Collecting/processing subject laboratory specimen according to protocol. Maintaining a thorough understanding of all data collection instruments and collecting data accurately and according to protocol.

Performing basic data gathering and manipulation of source documents and transcribing on EDC.

Maintenance of regulatory binders (ISF) with applicable documents.

Maintaining patient files.

Supervise all Clinical Research Coordinators and Clinical Research Assistants

Perform other duties as assigned by the Clinical Research Manager

Requirements

Experience preferred:

• 4 years of Clinical Research, with a strong understanding of clinical research regulations and guidelines.
• Additional past medical office experience. Preferred knowledge of the design ad conduct of clinical studies. Phlebotomy certification and experience preferred. Ophthalmology clinical research experience preferred.

Education required

• Bachelor's degree

Physical standards, including lifting and pushing requirements:

• Must be able to remain in a stationary position for 50% of scheduled shifts or more, be able to frequently move about the office to direct patients, access office supplies and equipment, and be able to lift up to 50 pounds. Must be able to communicate with patients to convey necessary medical and financial information and document accurately in EMR and practice management system.

Travel requirements:

• Study-related travel, including travel to clinic locations as needed and sponsor-related travel (investigator meetings, training, etc.).

Equipment:

• This position requires the use of telephone and office equipment such as computers, copier, fax machine, and scanner. Requires use of Microsoft Office products and occasional use of medical equipment such as exam chairs, imaging equipment, pharmaceutical refrigerators, and diagnostic testing equipment.

Unique conditions of the position:

• OSHA Classification Category I. Job duties include exposure to blood, bodily fluids, or tissues.