Pre - Clinical and Clinical Trial Specialist
We are seeking a clinical trial development specialist to join Centrose. The successful candidate will provide clinical and pre-clinical oversight for one or more projects and will join a team of leading experts focused on developing novel EDCs for the treatment of late stage cancer.
Job Description:
The clinical trial development specialist will work with colleagues across the company to plan, develop, design, and implement pre-clinical, clinical and early development trials. Additionally, the candidate will have accountability for medical monitoring, analysis, and reporting of studies. These programs will involve interactions and developing strategic relationships with research and clinical experts as well as regulatory agencies.
The candidate will oversee the development teams (employees, consultants and contractors), all necessary support in identifying and selecting Phase I investigators, and in completing the collation of all required documentation necessary so that investigational product can be shipped to sites in advance of patient enrollment in a given trial. This position requires a strong understanding and command of the basic skills necessary for the application of regulatory requirements, contractual/budgetary guidelines, and CRO and CMO SOPs/Work instructions to assigned responsibilities.
Position responsibilities include the following:
- Assist managers with the selection of investigators
- Work with investigative sites and ad-hoc team members to complete all documentation necessary so that investigational product can be shipped to sites in advance of patient enrollment in a given trial
- Identify investigators
- Negotiate with and budgeting site contracts
- Serve as a central contact for designated project reports, communications/correspondence, and associated documentation reviews and/or negotiates confidential disclosure agreements, regulatory documents, and contracts as required for site initiation
- Contact sites as required to resolve issues
- Determine completeness and readiness for clinical supplies/investigational product shipment
- Assist designated team members in preparing submissions for Independent Ethics Committees (IEC) or Institutional Review Boards (IRB) by compiling the package of documents for IEC/IRB and forwarding it to either the Investigator or IEC/IRB as directed.
- Assists clinical teams in evaluating the investigators performance at closeout to facilitate future site identification activities.
Preferred Qualifications/Experience:
- At least 2 years Clinical Research Coordinator (CRC) experience
- Associates or Bachelor's Degree in Health, Biological Science, or other related field, and 2 years related experience in health care field or other comparable combination of education, training and experience
- Basic knowledge and understanding of CRO clinical systems and procedures
- One to two years of hands on experience with regulatory documents including CRF's,ICF,FDA, and 1572's
- Possess basic knowledge and understanding of applicable regulatory regulations
- Possess good communication skills, both verbal and written
- Possesses good organizational skills
- Has a general working knowledge of clinical research
- Must be highly motivated
- Must be computer literate, including well developed computer skills in applicable software (eg. MS Word and Excel)
- Ability to utilize initiative and work independently as required
- Good at following instructions
Skills:
- CRC
- ICF Review
- IRB Submissions
- 1572
- Regulatory Review/Submissions
- Clinical Site Contract Review
- Protocol Review
