- Directs the development and execution of clinical trial activities for multi-center industry sponsored drug trials, including developing and revising study timelines. Engages with Finance for budget development and budget management.
- Serves as liaison to the Principal Investigator, study leadership, sites, vendors and sponsor. Oversees entire study team, including clinical trial sites (average 20 per trial), clinical and research laboratories, study medical monitors, biostatistics core, and data management team. Represents study team in meetings and during training sessions with sites.
- Leads internal study meetings and monitors progress toward meeting team goals and completing action items. Participates in planning larger scale external meetings, including development of agenda and meeting materials.
- Mentors, trains and manages more junior Clinical Project Coordinators as part of a study project team. Provides professional direction within clinical trials coordination team. Oversees study team interactions with study sites.
- Drafts and/or completes internal review of study documents (e.g., protocols, amendments, study plans, DSMB reports, grant submissions, annual reports) for review and approval by study leadership. Drafts requests and reports to regulatory agencies (e.g., IND application, annual IND update to FDA, etc.).
- Reviews monitoring reports and works with study monitors to finalize reports. Manages monitoring schedule in coordination with the monitoring team.
- Presents at larger scale external meetings, and well as other professional meetings.
- Careers
- Sign In
- New User
-
Clinical Trials Proj Mgr
3 weeks ago
University of Rochester Rochester, United StatesGENERAL PURPOSE: · Coordinates study activities for large multiple site international clinical trials and core laboratories for FDA, NIH and Investigator Sponsored Research clinical trials. Assists Manager in training of regulations, policies, and industry practices related to sp ...
-
Clinical Trials Proj Mgr II
1 week ago
The University of Rochester Rochester, United StatesThe Clinical Research Project Manager (CRPM) position involves working with multiple principal investigators across multiple clinical trials with a wide variety of assessment methods including patient-reported, biological, physiological, and electron Clinical, Clinical Research, ...
-
Clinical Trials Proj Mgr II
1 week ago
University of Rochester Rochester, United StatesGENERAL PURPOSE: · The Clinical Research Project Manager (CRPM) position involves working with multiple principal investigators across multiple clinical trials with a wide variety of assessment methods including patient-reported, biological, physiological, and electronic data. Un ...
-
Clinical Trials Sr Proj Mgr
1 week ago
University of Rochester Rochester, United StatesGENERAL PURPOSE: · Plans, directs and coordinates clinical studies ranging from phases I through IV to be compliant with FDA and NIH requirement, as needed. Manages multi-center and single center clinical studies and trials with extensive responsibility for staff supervision, ove ...
-
Clinical Trials Proj Mgr II
1 week ago
University of Rochester Rochester, United StatesOpening · Full Time 40 hours Range URG 111 Surgery-Cancer Control · Schedule · 8 AM-4:30 PM · Responsibilities · GENERAL PURPOSE: · The Clinical Research Project Manager (CRPM) position involves working with multiple principal investigators across multiple clinical trials with a ...
-
Clinical Trials Proj Mgr II
1 week ago
The University of Rochester Rochester, United StatesThis position requires working with cancer patients and survivors at Wilmot Cancer Institute locations by managing all research activities for Re. NEW within the PEAK Human Performance Science Program; a clinical and implementation exercise oncology Clinical, Clinical Research, E ...
-
Clinical Trials Proj Mgr II
2 weeks ago
University of Rochester Rochester, United StatesGENERAL PURPOSE: · This position requires working with cancer patients and survivors at Wilmot Cancer Institute locations by managing all research activities for ReNEW within the PEAK Human Performance Science Program; a clinical and implementation exercise oncology research prog ...
-
Clinical Trials Proj Mgr II
3 weeks ago
University of Rochester Rochester, United StatesOpening · Full Time 40 hours Range URG 111 Surgery-Cancer Control · Schedule · 8 AM-4:30 PM · Responsibilities · GENERAL PURPOSE: · The Clinical Research Project Manager (CRPM) position involves working with multiple principal investigators across multiple clinical trials with a ...
-
Clinical Trials Proj Mgr II
3 weeks ago
University of Rochester Rochester, United StatesGENERAL PURPOSE: · The Clinical Research Project Manager (CRPM) position involves working with multiple principal investigators across multiple clinical trials with a wide variety of assessment methods including patient-reported, biological, physiological, and electronic data. Un ...
-
Clinical Trials Proj Mgr II
3 weeks ago
University of Rochester Rochester, United StatesOpening · Full Time 40 hours Range URG 111 Surgery-Cancer Control · Schedule · 8 AM-4:30 PM · Responsibilities · GENERAL PURPOSE: · This position requires working with cancer patients and survivors at Wilmot Cancer Institute locations by managing all research activities for ReNEW ...
-
Clinical Trials Lead Proj Mgr
1 week ago
The University of Rochester Rochester, United StatesThe Clinical Project Lead directs and coordinates all aspects of multi-center international clinical research trials in a Contract Research Organization (CRO) environment and acts as a liaison to study leadership and sponsor(s). Individual ensures st Clinical, Clinical Research, ...
Clinical Trials Lead Proj Mgr - Rochester, United States - University of Rochester
Description
GENERAL PURPOSE:
The Clinical Project Lead directs and coordinates all aspects of multi-center international clinical research trials in a Contract Research Organization (CRO) environment and acts as a liaison to study leadership and sponsor(s).
JOB DUTIES AND RESPONSIBILITIES:
QUALIFICATIONS:
Bachelor's degree required with major course works in appropriate health, social science, or biological science field or equivalent combination of education and experience.
Clinical trials project management experience including extensive knowledge of protocol planning, implementation, coordination, evaluation, and reporting of clinical trials required.
Strong verbal and written communication skills, interpersonal skills, attention to detail and organization required. Clinical research professional/project management certification preferred.
The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University's mission to Learn, Discover, Heal, Create - and Make the World Ever Better.
In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law.
This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.
How To Apply
All applicants must apply online.
_EOE Minorities/Females/Protected Veterans/Disabled_
Pay Range
Pay Range:
$ 68,400 - $102,600 Annually
_The referenced pay range represents the minimum and maximum compensation for this job.
Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
_Apply for Job
Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening:
Schedule: