University of Rochester

Healthcare

Manager,ClinicalResearchData

$64–96k Rochester, New York, United States FULL TIME
The Brief

“Manager, Clinical Research Data at University of Rochester. Skills: Clinical research data, Data management, Staff management. Train clinical trials staff. Oversee clinical trials staff”

Industry & Context.

Healthcare
Problems you'll solve

Issue resolution

What They're Looking For.

Must Have

Bachelor's degree and 3 years experience, Proficiency in medical terminology, Proficiency in clinical research process, Proficiency in regulatory guidelines, Proficiency in managing priorities, Knowledge of GCP standards, Knowledge of safety standards, Knowledge of OSHA guidelines, Adherence to safety standards, Adherence to infection control standards, Proficiency in MS Office, Proficiency in email, Proficiency in internet, CCRP certification within 1 year, SOCRA certification within 1 year

Nice to Have

Master's degree preferred, Previous leadership experience preferred

What You'll Do.

Train clinical trials staff

Oversee clinical trials staff

Manage clinical trials staff

Manage data reporting

Delegate staff assignments

Ensure SOP compliance

Ensure GCP compliance

Oversee study personnel

Train study personnel

Document core competencies

Manage performance evaluations

Perform Quality Assurance

Supervise OnCore entries

Supervise research tabs

Train staff on software

Manage data coordination

Communicate with research team

Communicate with sponsor

Communicate with data centers

Communicate with monitors

Communicate with collaborators

Communicate with investigators

Communicate with personnel

Communicate with departments

Serve as point of contact

Provide coverage for data coordinators

Provide back-up for data coordinators

Resolve logistical challenges

Ensure study objectives achieved

Lead protocol data timelines

Appraise investigators of progress

Perform safety efforts

Perform quality improvement efforts

Minimize risk threats

Minimize safety threats

Plan strategies for occurrences

Follow-up on occurrences

Plan strategies for deviations

Follow-up on deviations

Develop corrective actions

Implement corrective actions

Develop preventive actions

Implement preventive actions

Participate in goal creation

Track department goals

Participate in recruitment initiatives

Participate in retention initiatives

Participate in team building

Participate in training activities

Keep current with policies

Keep current with laws

Keep current with SOPs

Keep current with guidelines

Keep current with industry standards

Keep current with best practices

Keep current with trends

Obtain clinical research certification

Maintain clinical research certification

Demonstrate accountability for learning

Maintain requisite skills

Maintain mandatory training

Maintain CITI certification

Maintain COI certification

Maintain proficiency in software

Keep up with new developments

Keep up with related literature

Keep up with clinical standards

Participate in protocol training

How You'll Work.

Team & Collaboration

Research team members; Laboratory staff; Patients and families; Clinical services

Communication Scope

Interpersonal skills

Free ATS check

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