Research - Laboratory/Non-Laboratory, Staff/Administrative
The Department of Oncology is seeking a Sr. Research Program Coordinator II. This position is responsible for coordinating the submission, approval and conduct of clinical trials in the Division of Hematologic Malignancies. Responsibilities include oversight of regulatory and data management staff within the division. The Sr. Research Program Coordinator II is responsible for developing and implementing effective data management and regulatory procedures, and ensuring research staff are properly trained for successful audits.
Duties and Responsibilities:
Daily screen the COVID patients for potential participants the Hopkins COVID Protocol Network.
Coordinate family contact for informed consent. All consent secondary to COIVD will be conducted via telephone (or video) and electronic signature consenting.
Electronically enroll each patient and coordinate enrollment with the Cellenkos for randomization and with our graft-engineering lab.
Facilitate protocol approval process and maintain regulatory compliance within the Program and the IRB
Ensure protocol compliance.
Maintain complete and accurate research data and charts in real time basis and are well prepared for auditing and monitoring visits.
Meet regularly with study team to review data accuracy and overall study progress.
Participate in all mandatory meetings to develop increasing knowledge of assigned clinical trial and registry requirements.
Participate in site initiation visits for studies where Hopkins is the Coordinating Center and our PI is the Lead or Protocol Chair.
Maintain communication with affiliate institutions to ensure high quality of data, timely submission of data, and adherence to guidelines.
Assist PI with protocol development, abstracts and manuscripts for different studies.
Actively participate in implementing the Clinical Research Management System (CRMS) within the Program.
Analyze data associated with clinical trials, as needed by the Program.
Ensure SKCCC Standard Operating Procedures are in practice.
Bachelor's degree in Biological/Social Sciences or related discipline. Related Master's preferred. Minimum of 5 years’ experience in complex and detailed clinical trials/medical research required. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum experience required for the respective job.
Minimum of two years clinical experience in clinical trial and or clinical research in a patient setting.
Proficiency in the use of software applications, databases, spreadsheets, and word processing.
Licensure, Certification, Registration:Certification as a Clinical Research Professional is preferred.
Additional Knowledge, Skills, or Abilities / Competencies:
Excellent organizational skills required
Excellent attention to detail skills required
Knowledge of medical terminology required
Familiar with medical procedure and laboratory fees
Ability to manage multiple and competing priorities
Knowledge of clinical research practices and principles required
Must have working knowledge of FDA reporting requirements
Must have excellent time management skills
Must have excellent oral and written communication skills
General computer skills, with experience with Microsoft Office
Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information.
Understands the importance/impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general.
Regular contact with physicians, other health care personnel and occasionally, patients, requires the use of good judgment, tact and sensitivity.
This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis. It should not be held to exclude other duties not mentioned that are similar in nature and level of difficulty.
Classified Title: Sr. Research Program Coordinator II Role/Level/Range: ACRP/04/MC Starting Salary Range: Employee Group: Casual / On Call Schedule: Sunday- Saturday (5-10 hours per week); Telecommuting Exempt Status: Exempt Location: School of Medicine, East Baltimore Campus Department Name: Oncology Hematologic Malignancies Personnel Area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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