Clinical Research Study Manager

2 months ago

Newark, United States Vitalief Inc. Full time

WHY VITALIEF?

Vitalief is emerging as an innovative Healthcare consulting company, focused on empowering Research and transforming Clinical Trials. As a result, we are seeking a talented and enthusiastic Clinical Research Study Manager to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients’ mission to impact and save lives.


Reasons to work for Vitalief:

  • You can actively contribute to our clients’ mission of advancing scientific discoveries that have the potential to change patients' lives for the better.
  • Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees.
  • We give everyone a seat at the table – we encourage innovation.
  • Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually.
  • Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from.


Salary Range: Market competitive - based on experience level.


Work Location: Newark, NJ


Responsibilities:

  • Reporting to the Director of Clinical Research Operations, provide support, establish workflows and processes to for high-quality clinical research activities for various Oncology Phase 2 through 4 trials.
  • Assures that all clinical research conducted is according to Good Clinical Practice (GCP) guidelines as well as applicable Institutional, State and Federal regulations and guidelines. In addition, this position is responsible for meeting the goals and objectives established by the management team.
  • Interacts and establishes appropriate with affiliate medical staff, executive staff, department heads and others to coordinate activities, expand services, establish efficiencies, resolve conflicts and foster an atmosphere of teamwork and cooperation.
  • Provides day-to-day supervision of clinical research staff (consisting of 4 team members) including support, guidance and training consistent with staff needs, relative to clinical trial activities.
  • Demonstrates leadership in examining staffing patterns, schedules, and making recommendations to ensure appropriate staff coverage and utilization of staff.
  • Works closely with the Management team in developing, implementing and evaluating standard operating procedures to support the clinical research program.
  • Ensures clinical research processes are patient centered.
  • Performs Quality Assurance audits regularly with the assigned team to ensure that the data collected is completed and accurate and to ensure that the research project, database or protocol is carried out as outlined.
  • Ensures that research protocols are approved by the Institutional Review Board and all regulatory documentation is completed prior to the initiation of the protocol.
  • Works collaboratively with physician colleagues, nurses, pharmacy, reception staff, partnering staff and all members of the Office of Human Research Services, appropriate hospital and laboratory staff to ensure that services are coordinated and delivered to patients in a timely manner.
  • Maintains working knowledge of DHHS, FDA, OHRP, NIH, GCP, HIPAA, IRB and other applicable guidelines.


Required Skills:

  • Bachelor’s Degree in a social science or related field.
  • 5 years of experience working in a clinical research institution (as opposed to working for a Sponsor and/or CRO).
  • 3 years of Oncology research experience.
  • One to two years of supervisory experience in a clinical research environment. Managing licensed medical professionals is a plus. Supervision in a unionized environment is a plus.
  • Solid leadership and people management skills; ability to foster a positive work environment and possess strong conflict resolution skills.
  • Strong verbal and written communication skills and ability to form cross functional leadership partnerships to accomplish goals.
  • Organizational and time management skills. Collaborative, energetic, team-oriented professional who is comfortable with change.
  • Capable of independent decision-making, and able to thrive in a fast-paced environment working on multiple clinical trials concurrently.
  • Association of Clinical Research Professional (ACRP) certification or Society of Clinical Research Associates (CCRP) certification required.
  • Advanced Microsoft office skills (Word, PowerPoint, and Excel).
  • Electronic medical record – EPIC experience (i.e. creating order sets) and Clinical Trials Management Systems (e.g., Velos, OnCore) experience.


PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs.


IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.

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