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Clinical Trial Site Manager

3 months ago

Anaheim, United States Redeployment Full time

CLINICAL TRIAL SITE MANAGER

POSITION: Clinical Trial Site Manager

LOCATION: Anaheim, CA; Full Time, On-Site (No remote option)

Our team has been hired to identify a Clinical Trial Site Manager for a leading research company that conducts Phase I-IV research studies and prides itself on its ability to improve the health and wellness of others while meeting and exceeding safety standards and enrollment goals. Their specialty areas include infectious disease, dermatology, gastroenterology, allergies, vaccines, sleep, and other indications.

This person will report directly to the Clinical Site Director & the Chief Financial Officer. They will lead a team of 5-10 research professionals at the Anaheim clinic. They will be on-site Monday-Friday to lead the team through difficult challenges, make impactful short-term and long-term decisions, and ensure the clinic operates smoothly and safely day-to-day.

In order to successfully fill this role, this person must be a strong leader, be a competent research professional, and be a caring advocate for the patient. They will work alongside the team as far as their professional credentials allow, see patients, work with samples and data, and solve problems as they arise. They will be expected to work independently, have experience in Clinical Trial processes and procedures to include the monitoring, analysis, and reporting of study data.

ROLES AND RESPOSIBILITIES:

  • Direct the daily operations of the clinic.
  • Assist with site feasibility evaluations and any documents and submissions relevant to site activation of new studies.
  • Manage the staff, to include training, daily schedules, and performance.
  • Interview and hire appropriate clinical support staff in collaboration with the Clinical Site Director.
  • Create quality control standards/procedures to ensure that the work of staff members is up to standard.
  • Schedule the physicians and medical professionals that support patient care.
  • Provide oversight during interim monitoring visits.
  • Ensures timely and accurate submissions to IRBs and sponsors.
  • Provide coverage for the study staff if needed (this may include conducting study visits with patients and processing laboratory samples).
  • Provide the staff with all resources needed to do a quality job, including training, materials, systems, and support.
  • Manage the facility, including the building and all equipment inside it.
  • Serve as the main liaison with all outside partners, including sponsors, contract research organizations, vendors, institutional review boards, and regulatory agencies.
  • Ensure that the entire clinic complies with all applicable regulations and best industry practices as well as GCP (Good Clinical Practice) and internal SOPs (Standard Operating Procedures).
  • Develop and implement patient recruitment strategies that meet our internal recruitment goals.
  • Ensure that each study is conducted with rigor, integrity, and efficiency.
  • Remain flexible during exceptionally busy times, as you will need to work beyond typical working hours and sometimes into the weekend.

EDUCATION AND EXPERIENCE REQUIRED:

  • Bachelor's degree in healthcare or physical science related subject or relevant industry experience
  • 3+ years of industry research experience (post education)
  • 2+ years of management experience
  • Clinical research experience
  • Excellent proven leadership experience overseeing teams of at least 4-6+ personnel
  • Excellent written and oral communication skills in English
  • Ability to evaluate, interpret, and synthesize scientific and clinical data; then verbally present and critically discuss clinical trial data in internal and external meetings
  • Must be legally authorized to work in the United States

PREFERRED ATTRIBUTES:

  • Professional degree in healthcare or physical science (PA, NP, RN, MS, etc.)
  • Phlebotomist
  • 5+ years of research experience
  • 2 years of clinical research experience
  • Hands on experience working with FDA, IND submissions/documents, processing and interpreting clinical development data

BENEFITS:

  • Salary: $90K - $110K; DOE
  • Potential Bonus (based on agreed upon metrics): DOE
  • PTO: 10-15 days (about 2 weeks) + Sick Days
  • Paid Holidays
  • Medical and Dental options available
  • Full benefits package to be discussed on a per-person basis