Clinical Research Coordinator 2, Joint Emerging Diseases Initiative (JEDI)

Benefits

Qualifications

• •Ability to work a flexible schedule, when needed, given the nature of the studies open to enrollment
• •Ability to work on weekends, when needed, given the nature of the studies open to enrollment
• •Ability to enroll COVID positive patients in the inpatient or outpatient settings
• •Ability to draw blood when necessary, or become phlebotomy trained
• •Non-Licensed CRC 2
• •Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications
• •Experience: At least one year of clinical research experience
• •Licensed CRC 2
• •Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications
• •Nursing Diploma may substitute for Degree for Licensed Registered Nurse
• •Experience: At least one year of clinical research experience
• •Licensure: Licensed to Practice in Clinical Profession such as (but not limited to): Registered Nurse, Athletic Training, Pharmacology, Medical Technology, Physical Therapy or Registered Respiratory Therapy
• •Excellent interpersonal, verbal and written communication skills
• •Excellent attention to detail
• •Comfortable using technology
• •Good problem-solving skills
• •Ability to work independently and as part of a team
• •Ability to switch tasks and thrives in a fast-paced environment
• •Ability to prioritize competing tasks and take initiative
• •Ability to plan and execute tasks and projects while maintaining flexibility and keeping the team abreast of status
• •Effective use of Microsoft Office (Word, Excel, PowerPoint, and Outlook)
• •Background checks, pre-employment health screenings, and drug screenings will be conducted on all new hires prior to employment
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Responsibilities

• •A Clinical Research Coordinator 2 will be expected to plan, organize, lead, and perform comprehensive and advanced level clinical research duties for multiple and / or complex clinical trials
• •Our preferred candidate for this position will have the ability to directly impact the overall efficiency, productivity and success of each clinical trial they coordinate
• •The CRC will work closely with physicians, research staff, study subjects, and departmental staff
• •The successful candidate will be responsible for coordinating all aspects of clinical research from study start-up through archiving of study records
• •As a key member of the research team, you will work closely with the Clinical Research Manager, other CRCs and several physician-investigators on our research trials
• •The successful candidate will be required to manage multiple complex clinical trials simultaneously in accordance with current regulatory requirements and maintain all study documentation in a manner that is ‘audit ready’
• •This position works closely with Principal Investigators and other research team members who specialize in the management of pulmonary and infectious diseases
• •Screen electronic medical records (EMR) for potential study candidates & track screening efforts
• •Recruit and obtain informed consent from study participants and maintain telephone and in-person contact
• •Manage ongoing study conduct activities such as: coordinate study visits, maintain concomitant medication records, track and report adverse events, organize subject study payments
• •Work closely with Principal Investigators and other study team members on all clinical research projects assigned
• •Notify PI and/or supervisor of any potential issues with the study or subject status
• •Able to work with minimal supervision
• •Demonstrate a working knowledge of the regulatory framework for FDA and non-FDA regulated studies
• •Facilitate and / or complete activities required for study start-up including: contract and budget negotiations, regulatory submissions and all communications with the study Sponsor
• •Coordinate multiple clinical trials or research projects simultaneously or manage large individual clinical trials that may be multicenter and complex in nature
• •Manage all aspects of ongoing clinical trial conduct from enrollment to off-study visits, data management, safety reporting and compliance oversight
• •Prepare and submit all regulatory documentation to the IRB such as: personnel changes, annual protocol continuations, protocol modifications, adverse event reports, unanticipated events
• •Reconcile study billing, identify charges covered by the study, versus charges to be billed to the subject/third party payor
• •Orient and/or provide basic training to new study team members
• •Ensure Sponsor is invoiced for study activity and reconcile payments received
• •Notify PI and / or supervisor of any potential issues with the study or subject status
• •Communicate effectively with study Sponsor(s)
• •Liaise with the other Departments within the institution to support clinical research activities
• •Demonstrate a high level of proficiency with the various electronic platforms utilized in clinical research such as: IRB Pro, Protocol Builder, CRConnect, OnCore, e-regulatory platforms and Epic
• •Support investigator-initiated research activity by conducting literature searches, collating research material, assisting with abstract or manuscript preparation
• •Demonstrate a continuously increasing level of clinical research knowledge gained through active participation in training and mentorship opportunities as well as self-guided learning
• •Process, prepare and ship study research samples
• •Support and providing guidance to faculty and trainees with clinical research projects in the department
• •In addition to the above job responsibilities, other duties may be assigned
• •This is primarily a sedentary job involving extensive use of desktop computers
• •The job does occasionally require traveling some distance to attend meetings, and programs
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