Senior Clinical Research Associate (CRA)

Employer
Samumed
Location
San Diego, CA or Remote
Posted
Jul 31, 2018
Required Education
Bachelors Degree
Position Type
Full time

About

Samumed is a pharmaceutical platform company based in San Diego, California, focused on advancing regenerative medicine and oncology applications through research and innovation (www.samumed.com). Samumed has discovered new targets and biological processes in the Wnt pathway, allowing the company to develop small molecule drugs that have the potential to address numerous degenerative conditions as well as many forms of cancer. Samumed is currently conducting clinical trials for multiple disease areas, including oncology, osteoarthritis, androgenetic alopecia, psoriasis, degenerative disc disease, and idiopathic pulmonary fibrosis, and it has a broad pipeline targeting areas of significant unmet medical need.

Job Description and Responsibilities:

Samumed is currently looking for a talented and experienced Senior CRA to join its team.  The Senior CRA participates in the planning, coordination, and monitoring activities of clinical trials in the Clinical Development Department. The Senior CRA will provide project support in the initiation, execution and close out of assigned clinical studies.  The Senior CRA co-monitors and mentors CRA I and IIs, and may have Clinical Project Manager tasks delegated to them.  Remote work opens are available for this position.  Primarily responsibilities for the Senior CRA role include:

  • Managing designated clinical trials, including investigator selection, analysis of potential patient recruitment, and preparation of trial related documentation (administrative and regulatory documents, consent documents, study manuals, study tools)
  • Organizing Ethics Committee submissions with follow through to ensure successful outcome
  • Participating in /presenting at Investigator Meetings
  • Organizing study Site Initiation Visits (SIVs) and develop SIV slides
  • Ensuring procedures are in place for appropriate optimization of patients into the clinical trial
  • Preparing for monitoring visits and monitoring the assigned clinical trial sites (6-8 sites) following company Standard Operating Procedures (SOPs) and in accordance with Good Clinical Practice (GCP).  Monitoring includes the ability to perform all visit types, pre-study, site initiation, interim and close-out visits
  • Planning the requirements for clinical trial material (Investigational Product (IP) and non-IP)
  • Serving as first point of contact for investigators/site personnel inquiring about patient inclusion/exclusion criteria for ongoing trials
  • Maintaining project files including the Trial Master File (TMF), and the following: Ethics Committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment
  • Completing word processing, spreadsheet and database assignments, including, but not limited to, correspondence, records, reports, scanning, emailing, copying, filing and other tasks
  • Creating and managing Investigator Site File and ensuring that all documents within the file are complete
  • Creating and maintaining contact lists and supportive documents for the Clinical Development Department and vendors
  • Tracking completed Case Report Forms (CRFs), and setting up systems whereby completed CRFs are rapidly entered into the database.  Ensuring that queries generated during cleaning are responded to in a timely fashion
  • Managing patient recruitment strategies to increase patient randomization into the trial (e.g., investigator and research nurse meetings, update newsletters, advertising, and letters to GPs)
  • Reviewing all SAEs, ensuring medical director sign-off, that sites are notified, and that all company procedures are complied with
  • Participating in departmental planning sessions and SOP development
  • Complying with institutional and departmental policies and procedures
  • Co-monitoring/mentoring CRAs and CTAs
  • Assisting with vendor management and review of specifications

Requirements:

  • 4 year life sciences or health care related degree
  • Minimum 3 years of experience independent monitoring
  • Proficient in MS Office software
  • Excellent verbal and written communication skills

TO APPLY, PLEASE EMAIL RESUME TO HR@SAMUMED.COM