RWE Site Manager 1 in Durham, NC at APEX Systems

Date Posted: 6/12/2019

Job Snapshot

Job Description

Job #:  978744
Our client is looking for a Site Manager to join their team in Durham, NC. Qualified candidates should have experience in different Phases of study (I-IV) and monitoring experience. If interested, please send your resume to Sarah at sdiscepoli@apexsystems.com!
 
PURPOSE
  • Engage in company training program to gain knowledge and skills required to independently conduct clinical remote monitoring visits and other clinical research activities in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements
  • Gain an understanding of all aspects of Real World Late Phase Research (RWLPR) site management and monitoring by striving to understand the work based on a combination of structured training programs, self-directed use of training materials and experience from study assignments.

RESPONSIBILITIES
  • Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
  • Gain experience with standard tools, metrics and reports. Develop an understanding of how sites are staffed and operate in order to build strong relationships with personnel at assigned sites
  • Gain experience in study procedures by working with experienced Site Management staff. May also work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.
  • Under close supervision, may perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, good clinical practices applicable regulations, SOPs and work instructions.
  • Under close supervision, administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
  • Escalate quality issues to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager. Under close supervision, manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
  • Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint Strong written and verbal communication skills in applicable languages, and business level command of English Basic organizational, interpersonal and problem-solving skills
  • Strong attention to detail Working time management skills
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • Degree or currently enrolled in bachelor's degree program preferably in life science; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS
  • Extensive use of telephone and face to face communication requiring accurate perception of speech
  • Extensive use of keyboard requiring repetitive motion of fingers Regular sitting for extended periods of time
  • May require occasional travel (very rare, and extremely close when needed)

 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.