PURPOSE
Engage 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 practice, and applicable regulatory requirements.
RESPONSIBILITIES
- Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
- Gain experience in study procedures by working with experienced clinical staff in Clinical Research Associate (CRA), Clinical Team Lead (CTL) and Clinical Trials Assist (CTA) roles. May also work collaboratively with other functional groups such as data management and pharmacovigilance.
- Under close supervision, perform site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.
- Under close supervision, administer protocol and related study training to assigned sites and establishes 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 CTL and/or line manager.
- Under close supervision, manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, 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 and other required study documentation.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
- Strong written and verbal communication skills including good command of English language
- Excellent organizational and problem-solving skills
- Effective time management skills
- Ability to manage competing priorities
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Degree or currently enrolled in bachelor’s degree program in health care or other related discipline.; 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
- Frequent travel to sites, primarily domestic, may include international travel
