Clinical Rsch. Prog./Proj. Mgr
Under the direction of the Senior Program Manager, the Clinical Research Project Manager will oversee and assist with key components of the multi-center research program, including the coordination of multiple Investigator-initiated clinical trials, the development and implementation of program procedures and initiatives and the training, supervision and mentorship of junior staff.
Responsibilities include:
Coordination, monitoring and timeline management of multiple clinical trials and research projects within the program
Ongoing monitoring and evaluation, across all participating sites, of protocol, regulatory and data compliance and assessment of compliance with federal and local regulations
Working directly with entities within and outside the organization, including PIs, Sponsors and collaborators, to resolve workflow issues and improve process
Identifying changes associated with Standard Operating Procedures and developing processes to ensure compliance
Ensuring timely reporting to all sponsors, monitoring, safety and regulatory boards (e.g. FDA, IRB, DSMB, etc)
Training of new staff and assessment of ongoing continuing education needs
First-line supervision of research staff, especially on coordination of their own research portfolio
Assisting staff with task prioritization for project assignments
Mentoring junior staff
Executing new hire, corrective action and performance evaluation processes for direct report research staff
Staying current with federal and local regulations, guidance and quality assurance trends as they pertain to the conduct of clinical research.
Skills Required:
3-5 years related experience
Exceptional project management, time management and organization skills
Excellent written and verbal communication skillsKnowledge of current and developing clinical research trends
Sound interpersonal skills and the ability to supervise others
Ability to work independently and display initiative
Ability to identify problems and develop solutions
Demonstrated ability to successfully manage multiple projects and tasks
Established rapport with investigators and sponsors with the ability to resolve operational matters
Ability to effectively supervise and train staff
Familiarity with the Code of Federal Regulation (CFR) and Good Clinical Practice (ICH GCP)
Occasional domestic travel required
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities include:
Coordination, monitoring and timeline management of multiple clinical trials and research projects within the program
Ongoing monitoring and evaluation, across all participating sites, of protocol, regulatory and data compliance and assessment of compliance with federal and local regulations
Working directly with entities within and outside the organization, including PIs, Sponsors and collaborators, to resolve workflow issues and improve process
Identifying changes associated with Standard Operating Procedures and developing processes to ensure compliance
Ensuring timely reporting to all sponsors, monitoring, safety and regulatory boards (e.g. FDA, IRB, DSMB, etc)
Training of new staff and assessment of ongoing continuing education needs
First-line supervision of research staff, especially on coordination of their own research portfolio
Assisting staff with task prioritization for project assignments
Mentoring junior staff
Executing new hire, corrective action and performance evaluation processes for direct report research staff
Staying current with federal and local regulations, guidance and quality assurance trends as they pertain to the conduct of clinical research.
Skills Required:
3-5 years related experience
Exceptional project management, time management and organization skills
Excellent written and verbal communication skillsKnowledge of current and developing clinical research trends
Sound interpersonal skills and the ability to supervise others
Ability to work independently and display initiative
Ability to identify problems and develop solutions
Demonstrated ability to successfully manage multiple projects and tasks
Established rapport with investigators and sponsors with the ability to resolve operational matters
Ability to effectively supervise and train staff
Familiarity with the Code of Federal Regulation (CFR) and Good Clinical Practice (ICH GCP)
Occasional domestic travel required
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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