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Clinical Research Manager
Clinical Research ManagerDayton Physicians • Kettering, Ohio, USA
Clinical Research Manager

Clinical Research Manager

Dayton Physicians • Kettering, Ohio, USA
21 days ago
Job type
  • Full-time
Job description

Dayton Physicians Network is looking to add a Clinical Research Manager to our team!

Summary :

Assist with daily operations of clinical research by overseeing ongoing research studies and adhering to project timelines working closely with study sponsors research teams and external SMOs and IRBs. The manager will support investigators clinical staff and patients with the required activities and operations of their studies. Ensure proper quality assurance measures are taken develop source documents patient study records operational workflows and oversee the completion of study visits data entry and specimen processing and comply with all regulatory requirements. May select train and evaluate clinic research staff members.

Schedule : Monday through Friday 8 : 00am - 4 : 30pm

No weekends evenings or holidays!

Work / life balance schedules

Why work for Dayton Physicians Network

  • Full-time employees are eligible for health dental and vision benefits
  • Company holidays and a flexible holiday!
  • Generous Paid Time Off (PTO) Package

Additional accrual increase after 1 year of service with Dayton Physicians!

  • 401K
  • Scrub Allotments
  • Yearly Bonus Program
  • Dayton Physicians Network as an Independent Practice
  • DPN Core Value Expectations :

    TheCARESmodel reflects the principles that guide our day-to-day behaviors; our decisions our actions and our relationships with each other and with the patients and families we serve. All DPN employees are expected to embrace and demonstrate the following :

  • C OMPASSION : the patient is at the center of all we do
  • A CCOUNTABILITY : we hold ourselves accountable for our actions
  • R ESPECT : we show respect for others
  • E XCELLENCE with Innovation : we strive for excellence in all we do
  • S ERVICE through Collaboration : we provide service to our patients team members and community.
  • Essential Duties and Responsibilities :

  • Oversee clinical trials from planning to completion.
  • Ensure adherence to protocols budgets and ICH-GCP / FDA expectations.
  • Develop and refine standard operating procedures to improve efficiency and consistency.
  • Conduct process improvement through evaluation of workflows development of documentation and communication with key stakeholders.
  • Recruit mentor and manage clinical research staff.
  • Conduct performance reviews lead meetings and provide training.
  • Monitor study progress including patient enrollment and data submission and perform quality oversight.
  • Attend and lead team meetings prepare reports and communicate additional information around study activities as needed.
  • Manage the efforts of the team and assign / train team members on required job duties.
  • Coordinate clinical trial activities.
  • Gather and verify source documents.
  • Verify the accuracy completeness and timely submission of case report forms.
  • Collaborate with investigators to ensure protocol compliance in patient selection treatment dose modifications and response.
  • Interview patients to assess adverse events medication compliance and patient-reported outcomes.
  • Obtain follow-up data required when a patient is off active treatment.
  • Maintain investigational drug (IND) inventory.
  • Review protocol and assess current inventory of IND.
  • Maintain inventory on individual drug accountability records.
  • Ensure treatment orders are correct by reviewing protocol guidelines and calculating doses prescribed.
  • Gather complete and track investigator-required forms that comply with federal and institutional guidelines. Ensure physician investigators complete required protocol training prior to patient enrollment.
  • Coordinate credentialing of laboratory radiology and radiation equipment as required by protocol.
  • Use the research database to track patient enrollments demographics and status. Run reports to provide information to physician investigators and administrators.
  • Disseminate protocol information.
  • Review and educate physician investigators on new protocol activations closures and revisions.
  • Serve as a professional resource regarding clinical trials protocol procedures and compliance for investigators nurses pharmacists pathologists radiologists and other healthcare personnel.
  • Demonstrate clinical competency by providing direct patient care as required by protocol (EKGs vitals lab draws). Obtain protocol-specific training as required to enroll patients in clinical trials.
  • Order and track laboratory kits needed for research-related blood draws. Process and ship specimens as required by protocol. Maintain hazardous materials education certification.
  • Travel between locations as needed.
  • Perform other duties as assigned.
  • Supervisory Responsibilities :

    Oversees Research Staff

    Required Education and / or Experience :

  • Bachelors degree with a focus in science or medicine preferred.
  • A minimum of 5-7 yeas of clinical research experience with a significant focus in a senior role.
  • Project Manager or similar management position preferred.
  • General Skill Requirements :

  • Excellent oral and written communication
  • Working knowledge of Microsoft Office including Word Excel and Outlook.
  • Experience working with a Practice Management system.
  • Attendance and punctuality are essential requirements of this position to provide excellent customer service to both our internal and external stakeholders.
  • Required Experience :

    Manager

    Key Skills

    CSS,Cloud Computing,Health Education,Actuary,Building Electrician

    Employment Type : Full Time

    Experience : years

    Vacancy : 1

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    Clinical Research Manager • Kettering, Ohio, USA

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