Clinical Trials Project Leader II

Employer
Catalyst Clinical Resourcing, LLC
Location
Durham, NC
Posted
Oct 09, 2017
Jobs Outside Higher Education
Other Jobs Outside Higher Education
Institution Type
Outside Academe


Job Description

Occupational Summary:
Develop, coordinate, and implement research and administrative strategies essential to the successful management of phase II, III and/or IV clinical trials research projects conducted by principal investigator(s); perform a variety of duties involved in the organization, documentation and compilation of clinical research data; function in preceptor capacity for Clinical Trials Project Leader I's.

Work Performed:
  • Develop, coordinate, and implement research and administrative strategies essential to the successful management of phase II, III and IV clinical trials research projects conducted by principal investigator(s); perform a variety of duties involved in the organization, documentation and compilation of clinical research data; function in preceptor capacity for Clinical Trials Project Leader I's. Recommend guidelines and refinement of guidelines in the collection of clinical data and administration of clinical trials; assist in the determination of guidelines for new protocols. Assist principal investigator and other team members in the development of plans, time lines, and processes for clinical research studies; coordinate the ongoing analysis and modification of protocols; recommend amendments to study protocols as appropriate. Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations; assure adherence to Federal Drug Administration and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate. Coordinate and lead the work of the Project Leader I staff and research team and provide feedback to staff's supervisor on a routine basis; conduct cross functional research team meetings as needed. Participate in conjunction with the principal investigator in initial contacts with outside vendors and internal functional groups for potential projects including early trial budget negotiations and contract development. Perform other related duties incidental to the work described herein.


The above statements describe the general nature and level of work being performed by individuals assigned to this
classification.

This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

EDUCATION/TRAINING
Work requires graduation from an accredited degree program providing clinical training as a Registered
Nurse (RN), Physician's Assistant (PA) or Pharmacist plus three years of healthcare experience; or one of
the following equivalents:
1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed
Practical Nurse) plus a minimum of six years healthcare experience; or
2. Completion of a master's degree in Public Health, Health Administration or a related area with two
years directly related clinical trials research experience; or
3. Completion of a bachelor's degree plus a minimum of four years directly related experience in clinical
trials research; or
4. Completion of a bachelor's degree plus a minimum of five years closely related research experience.
**Driver's license may be required.**

EXPERIENCE
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
SKILLS

Excellent Benefits!

Company Description
You may not recognize the name, but you know who we are. You know us as innovative outsourcing and resourcing leaders from The Woolf Group, Trio and Novella Clinical Resourcing. Once again, Betsy Brown and Jean Hendrickson have teamed up to bring innovative, cost-effective and highly collaborative resourcing solutions to meet the growing challenges of CROs and Sponsors in research and development today, as well as fascinating opportunities to clinical research professionals looking to advance their career.


Durham, NC

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Sun, 8 Oct 2017 13:42:23 PDT

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