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HJF is seeking a Lead Clinical Research Coordinator/Site Supervisor to support the Infectious Disease Clinical Research Program (IDCRP) located at the Landstuhl Regional Medical Center. HJF provides scientific, technical and programmatic support services to IDCRP.
The position responsibilities are to perform clinical research in conjunction with multiple specified clinical research protocols, to serve as a mentor for junior staff and perform as a Site Supervisor and senior coordinator on multi-site research protocols for the Infectious Disease Clinical Research Program. Further responsibilities include ensuring that accurate documentation is kept along with complying with all governing regulations.
- Recruits and interviews individuals for clinical trials, collects and analyzes data to validate eligibility and patient commitment, and obtains informed consent.
- Obtains pre-screening medical documents by communicating with appropriate sources.
- Conducts counseling sessions for patients and informs them of their rights and responsibilities.
- Educates patients about the clinical trial, their roles in the protocols, and any other vital information. Acts as a research case manager for the patients. Serves as a resource for the patients.
- Provides patients with documentation validating their study participation as needed.
- Collects data appropriate to the research protocols. Analyzes data resulting from the tests performed on the patients. Reports results that warrant prompt action to the research physicians. Determines whether data is clinically significant.
- Administers appropriate drugs/devices/infusions to patients as specified in protocols. Draws blood and obtain other specimens as specified in protocols.
- Acts as a liaison between patients and physicians. Observes the patients for improvements, setbacks, and changes in conditions.
- Prepares and maintains manual and electronic data in patient study books according to prescribed standards.
- Transcribes data into data capture system.
- Transcribes and resolves queries of data in case report forms (hardcopy or electronic) and prepares documents, under direction of project heads, reporting statistical analyses and descriptive data from patient's study books to be used in research reports.
- Collects, organizes, catalogs, disseminates, and maintains appropriate files of current data.
- Maintains weekly/monthly status reports on all patients.
- Serves as manager for the study site, overseeing employees in the fields of regulatory affairs and clinical research coordinators.
- Provides guidance as necessary to staff members and conducts performance reviews in conjunction with Principal Investigator.
- Performs budget development duties, site coordination for space and schedules for employees.
- Identifies potential problems or obstacles in the study design and trends in patient reactions to treatment.
- Adheres to legal, professional, and ethical codes with respect to confidentiality and privacy. Assures that protocol requirements are achieved within Good Clinical Practice.
- Prepares and coordinates with monitoring audits/visits for multiple protocols.
- Coordinates the communication with other research staff from other sites and external organizations to obtain research materials and/or coordinate patient care for research protocols.
- Locally travels to/from their assigned workplace to support protocols as needed.
- Provides advice on personnel utilization, workflow, and operational procedures to increase efficiency, productivity, and make overall improvements for the program.
- Trains, where appropriate, personnel and participates in the hiring process of new employees.
- Coordinates and approves the initiation and processing of purchase orders, supply sources, work orders, and maintenance and renovation requests.
- Must be able to obtain a Department of Defense Common Access Card. This process includes a background investigation that consists of a Federal Bureau of Investigation (FBI) fingerprint check and a National Agency Check with Written Inquiries (NACI) check.
- Other duties as required.
Non-Essential Job Duties:
- Schedules patients for appointments and visits.
- Participates in special projects as needed.
- Writes and updates SOPs where appropriate.
- Reviews protocols/IC/budgets during the development phase with investigators.
- Serves as the lead CRC for multi-site research protocols and may supervise junior staff where appropriate
- Serves as a mentor to junior staff.
- Performs other duties as needed.
Required Knowledge, Skills, and Abilities: Knowledge of federal and local regulations and policies pertinent to research involving human subjects; knowledge of procedures and techniques necessary for performing research tasks; ability to learn and become proficient in data acquisition and clinical responsibilities related to research protocols; excellent interpersonal and computer skills; ability to communicate effectively and to work with and manage individuals of all levels
Minimum Education/Training Requirements: Bachelor's degree in Nursing, Biological Sciences, or Public Health
Minimum Experience: 4-6 years in clinical research and/or nursing management positions.
Physical Capabilities: Long periods of standing; some bending, lifting, and walking; escorting patients and carrying light items; may encounter patients who are confused, agitated, or abusive
Licenses, Certification or Registration: Licensed as a Registered Nurse, certified in basic cardiac life support, and Phlebotomy Training/Certification required.
Certified as a Clinical Research Coordinator (CCRC), Clinical Research Professional (CCRP) and/or Clinical Research Associate (CCRA) is a strong plus.
Supervisory Responsibilities/Controls: Will supervise staff working on the research project
Work Environment: Laboratory, office, or clinical/hospital environment; possible evening and/or weekend hours.
Other: Due to the Status of Forces Agreement (SOFA), this position must be filled by a trailing spouse.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Vice President of Human Resources.
HJF is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.