Clinical Research Coordinator IV (Project Manager)
Location: Cherry Hill
Posted on: March 11, 2023
I have a great opportunity for clinical research professionals
looking to expand their careers into clinical project management! A
NCI designated, Cancer Center based in Southern New Jersey is
actively looking for a Project Manager to help grow their research
program. The ideal candidate will have 5+ years of clinical
research experience and leadership skills. Please apply if
qualified and interested. While this role does allow flexibility to
work from home, candidates must be located in the Greater
Philadelphia or Southern New Jersey area. PRIMARY FUNCTION : The
Clinical Project Manager trains research staff, supervises staff
and oversees clinical trials from start-up to close-out. Develops
and/or contributes to standard operating procedures and processes.
Attends and engages in leadership meetings, represents hospital
internally and externally, and oversees research operation in
department, and provides expert consulting at an institutional
level. ESSENTIAL FUNCTIONS:
- Manages all Investigator-lead multi-site trials by developing
and implementing processes for document management and IRB
submission tracking (i.e. continuing reviews and amendments) for
multi-center trials as well as have protocol status knowledge.
- Directs the preparation and submission of regulatory agency
applications, reports, and correspondence for opening new studies,
protocol amendments, informed consents, continuing reviews, FDA
safety reporting, Investigational New Drug applications (INDs),
annual reports, Investigational Device Exemption applications
- Provides direct supervision of the research staff which
includes conducting on-going training, reviewing workloads,
completing annual evaluations, etc.
- Oversees documentation efforts to ensure compliance with
domestic and international regulations and standards.
- Identifies issues, recommends changes, writes new standard
operating procedures (SOPs) or update existing SOPs with the goal
of enhancing regulatory compliance.
- Interacts with co-workers, visitors, and other staff consistent
with hospital values.
- Oversees the completion of all necessary regulatory
preparations prior to sponsor visits (e.g., monitoring and auditing
visits, site activation visits). Ensures that any regulatory action
items resulting from a sponsor visit are completed in a timely and
- Ensures that regulatory document version control is maintained,
and that all clinical trial documentation is "audit ready" at all
- Reviews all regulatory submission materials to ensure
timeliness, accuracy, comprehensiveness, or compliance with
- Creates and establishes a process for ensuring quality
submissions to the IRB and the FDA.
- Interacts with Principal Investigators (PIs), Research
Institute, Office of Research Administration (ORA), Office of Human
Research (OHR), hospital staff, etc. to ensure efficient processing
- Works with the Team to ensure all communications regarding
regulatory documentation that are provided by sponsors are
distributed and received by the regulatory staff in a timely
- Actively participates and represents the departments in
- Manages all aspects of clinical research regulation from
protocol inception to completion; and tracking quality metrics
- Directs regulatory documentation and workflow for clinical
trials through the use of project management techniques and tools
(e.g., spreadsheets, progress reports, priority setting).
- Maintains an efficient organizational structure for processing
all clinical protocols assigned to the Team, which includes NCI
cooperative group protocols, industry-sponsored trials, and
investigator-initiated studies including multi-sites.
- Performs other duties as assigned. EDUCATIONAL/TRAINING
REQUIREMENTS : Minimum of bachelor's degree EXPERIENCE REQUIREMENTS
: Minimum of five years of clinical research experience; or
Master's degree and a minimum of three year of clinical research
experience About Actalent: Actalent connects passion with purpose.
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Keywords: Actalent, Cherry Hill , Clinical Research Coordinator IV (Project Manager), Healthcare , Cherry Hill, New Jersey
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