Engages in company training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practices, and applicable regulatory requirements. Will engage in extensive training with enhanced oversight as well as dedicated mentoring from senior Clinical Research Associates (CRAs) and Managers.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Complete appropriate therapeutic, protocol, clinical research, SOP and systems training to perform job duties.
• Gain experience in study procedures by working with experienced clinical monitoring staff.
• Under close supervision:
  • Perform site selection (if applicable), initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.
  • If applicable, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas to CRA and/or CTM for improving site recruitment plan in line with project needs to enhance predictability. Assist CRA and/or CTM in tracking subject site recruitment progress.
  • Administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues. Convey features and opportunities of study to site.
  • 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 as appropriate.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution. Under close supervision may support start-up phase.
• Collaborate and liaise with study team members for project execution support as appropriate.

KNOWLEDGE, SKILLS AND ABILITIES:

• Knowledge of clinical research process and medical terminology.
• Experience in clinical research and/or coordinating clinical trials.
• Experience in oncology, biopharma, cardiovascular, metabolic, or renal studies
• Good organizational, problem-solving and interpersonal skills.
• Effective time management skills.
• Ability to reason independently and recommend specific solutions in clinical settings.
• Good written and verbal communication skills including good command of English language.
• Ability to collaborate and communicate with a variety of colleagues and customers.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
• Able to qualify for a major credit card. (US Only)
• Valid driver’s license; ability to rent automobile.
• Ability to travel approximately 65%-85%, domestic or international, as required

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Ability to travel domestically and/or internationally as required
• Very limited physical effort required to perform normal job duties
• 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

MINIMUM RECRUITMENT STANDARDS:

• Clinical research coordination experience at site level
• Nursing or University Degree (US Bachelor Level or equivalent) in one of the life sciences
• Knowledge of electronic data capture preferred
• Equivalent combination of education, training and experience