Home Invites Members Groups Events Careers Videos News Photos Blogs Polls Singles Forums Chat
Home > Career Center > Job Seekers > Job Search
Job Title: Clinical Research Project Manager
Location: Medley, FL United States
Position Type: Full Time
Post Date: 09/23/2021
Expire Date: 11/23/2021
Job Categories: Customer Service and Call Center
Job Description
Clinical Research Project Manager
Description:

The Office of the Vice Provost for Research & Scholarship, Clinical Research Management & Support Office (CRMSO) has an exciting job opportunity for a Clinical Research Manager at the Medical Campus.

/> The Manager, Clinical Research oversees the planning and management of clinical trials and research projects that support the overall mission of the University. This role is also responsible for the independent execution of regulatory-related decisions/strategies; and coordinates central resource services for principal investigators and other relevant team members.

Additionally, an employee at this level, as a Research Professional Associate, (RPA II) promotes clinical research by providing quality services related to research reviews, advanced QA and QA assessments, research program management and educational functions, by applying a solution-based, collaborative approach with the goal of continuous quality improvement.
>
Core Job Functions:

Analyzes research programs and proactively identifies trends.

Conducts audits of research protocols.

Assists in investigations as directed.

Pre
pa
res and creates audit and investigation.

Conducts reviews of protocol and other submissions and communicates with researchers as it relates to regulatory deficiencies.

Assists with Research Program management.

Creates and presents research-related educational materials within and outside the University of Miami.

Prepares documents for submission to federal agencies.

Keeps abreast of current federal regulations and guidance documents, State laws, University of Miami policies and procedures as well as departmental SOPs and informs OVPRS leadership of changes.

Promotes quality improvement and best practice solutions.

Communicates with the research community, all OVPRS groups and external customers as applicable and provides consistent excellent customer service.

Department Specific Functions:

Prepares for or participates in
qua
lity assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.

Prepares and oversee the development of study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.

Participates in the development of study protocols including guidelines for administration or data collection procedures.

Oversees subject enrollment to ensure that project timelines are being met.

Tracks enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.

Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential sub
ject r
isks.

Participates in preparation and management of research budgets and monetary disbursements and tracks items related to CDAs, budget and contract completion status.

Assists in preparing Clinical Study Reports and annual safety reports.

Reviews monitoring reports for accuracy, completeness, and conformance with SOPs.

Maintains frequent contact with and works effectively and collaboratively with investigators and study team members, as well as other departments and groups.

Provides guidance, clinical trial management expertise, and direction to contract CRAs in the field and in-house staff.

May monitor/audit clinical sites for adherence to protocol and GCP, including conducting site pre-qualification, initiation, monitoring visits, and close-out visits or co-monitoring visits conducted by monitoring personnel.

Assurance of regulatory compliance of investigati
onal sit
es with company SOPs, EMA/FDA and ICH-GCP guidelines.

Reviews and/or submission of research ethics committee/regulatory documentation.

Identifies, selects, and monitors performance of investigational sites for clinical studies; prepares accurate and timely visit reports from all site interactions and visits.

Develops and maintains good working relationships with investigators and study staff.

Ensures studies are carried out according to the study protocol, SOPs, and ICH-GCP, federal regulations and study-specific manuals and procedures.

Assists with establishing and tracking critical timelines and appropriate performance metrics.

Reviews key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determines appropriate action in conjunction with study team.

Investigates queries and monitors discrepancies as applicable.

Mana
ges and ov
ersees investigational product (IP) accountability and reconciliation process.

Responsible for review or approval of IP release packages in collaboration with monitoring project team members.

Minimum Qualifications:

Masterís degree in relevant field required.

Minimum 5 years of relevant experience. Any appropriate or equivalent combination of education, training, and experience and/or certification may be considered.

Knowledge, Skills and Attitudes:

Advanced knowledge of research related federal regulations, guidance documents and State laws.

Must be able and willing to provide excellent customer service at all times.

Must be able to communicate effectively and customer-service oriented verbally and in writing.

Ability and willingness to continuous quality improvement and learning.

Proficie
nt in computer software (i.e. Microsoft Office).

Advanced knowledge about Project Management Concepts.
Share |
Contact Information
Website:https://www.aplitrak.com/?adid=dC5ydWl6LjcxNDE3LjM2NTlAbWlhbWloZWFsdGguYXBsaXRyYWsuY29t
Company Description:

Please visit our employer showcase!
Apply Now | Forward Job to a Friend | More Jobs From This Employer

(Advertise Here)
Who's Online
>> more | invite 
Black America Resources
100 Black Men of America
www.100blackmen.org

Black America's Political Action Committee (BAMPAC)
www.bampac.org

Black America Study
www.blackamericastudy.com

Black America Web
www.blackamericaweb.com

CNN Black In America Special
www.cnn.com/blackinamerica

NUL State of Black America Report
www.nul.org

Most Popular Bloggers
deacon ron gray has logged 161836 blog subscribers!
agnes levine has logged 63742 blog subscribers!
tanisha grant has logged 42013 blog subscribers!
steve williams has logged 26208 blog subscribers!
kamal imani has logged 10048 blog subscribers!
>> more | add 
Latest Jobs
Business Development & Fundraising Manager with National Association of Charter School Authorizers in CHICAGO, IL.
Transfer Pricing Associate with FMC Corporation in Philadelphia, PA.
Equity and Inclusion Manager with Otak in Portland, US.
Partnerships Coordinator with World Learning in Washington , DC.
Master Scheduler (The Miami Project) with University of Miami Health System in Miami, FL.
>> more | add