Clinical Research Coordinator IV - Cardiology
About The Position
A bachelor’s level, master’s preferred, Clinical Research Coordinator IV (CRC IV) position is open for an active, multi-site R01 study. The study is focused on the use of wearable sensors to measure physical activity and predict clinical change in children with pulmonary hypertension. The CRC IV will support all study activities throughout the grant period. To best support the project, the ideal candidate will have at least 5 years of experience in research/clinical coordination and great familiarity with Institutional Review Board practices, human subject protection, and data management systems in order to perform independently under the PI's supervision. The CRC IV will work closely with the PI in supporting the day-to-day management of administrative and clinical project tasks including monitoring study activities, meeting regulatory requirements, managing communications with the 6 sub-award sites, facilitating and obtaining study participants’ consent to participate in the proposed study, serving as a liaison between the activity analysis team and the rest of the CHOP study team, providing patient education alongside the PI during participant enrollment, and supervising the CRC I on the team. Additional comments - Experienced research professional skilled in managing a multi-site observational study High degree of independence while also working in close partnership with CHOP PI Excellent communicator willing to manage frequent communication between PIs, study staff, families, and research administration History of regulatory and compliance excellence Experience managing large budget along with PI and research business administration Technological comfort in transferring data from wearable sensors to a cloud-based analysis platform (no analysis experience required)
Requirements
- Bachelor's Degree Required
- At least five (5) years of clinical/research coordination experience Required
- Intermediate knowledge of IRB and human subject protection
- Intermediate proficiency in data management systems/tools
- Familiarity with Clinicaltrials.gov
- Excellent verbal and written communications skills
- Excellent time management skills
- Strong analytical skills
- Ability to collaborate with stakeholders at all levels
Nice To Haves
- Master's Degree in a related field Preferred
- At least seven (7) years of clinical/research coordination experience Preferred
Responsibilities
- Applies in depth knowledge of clinical research and independently coordinates the activities of multiple large-scale, complex multi-center / multi-institutional studies
- In partnership with other business units, prepares, negotiates and manages study budgets and finances with the PI
- Coordinates and participates in the process of contract negotiation and finalization and is well-versed in contract language and study team responsibilities
- Accountable for study oversight and monitoring activities at multiple sites/institutions
- Prepares study sites for internal/external regulatory audits (sponsor, FDA, NIH, etc)
- Supervises and trains new staff, contributes and completes staff annual performance reviews as appropriate
- Leads research/project teams
- Educates and mentors internal and external clinical staff, research teams and other coordinators; provides resources, and consulting on difficult protocols or projects
- Independent of the PI assesses and critiques protocol feasibility and provides high level recommendations
- May support multiple PI sponsored INDs or IDEs
- Serves on clinical research committees/activities within division or institution.
- Screens, recruits and enroll patients/research participants
- Report adverse events
- Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
- Must comply with federal, state, and sponsor policies
Benefits
- annual influenza vaccine
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What This Job Offers
Job Type
Full-time
Career Level
Senior
