Site Management Associate
PRA Health Sciences
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
As a Site Management Associate, you are a primary point of contact/liaison for the sites, Sponsor and internal stakeholders during the study life cycle. You will perform investigative site communication, essential document collection and review, maintenance and close-out in-house site management activities in accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements. You will work collaboratively with your study teams, sites, and clients.
The Site Management Associate performs essential document collection and review, clinical status tracking, in-house site management, and data review activities in accordance with the project protocol, client and/or PRA standard operating procedures (SOPs), and all applicable guidelines and regulatory requirements (e.g. ICH-GCP, and country/region specific).
- Assists in identifying study sites by performing site feasibility and recruitment tasks, e.g., completing, disseminating and reviewing responses to site recruitment questionnaires.
- Collects essential regulatory documents from sites, and ensuring compliance with regulatory and ICH/GCP guidelines and PRA SOPs.
- Works with Informed Consent Form updates, collaborating with sites on updates and ensuring appropriate IRB submissions and approvals.
- Sets up and maintains site-related data in applicable clinical systems according to procedures and guidelines.
- Acts as primary site contact/liaison for study and site management issues including addressing questions, inclusive of protocol questions, managing study supplies and conducting offsite central monitoring visits/contacts (pre-study, initiation, monitoring and close out visits). Escalates issues and risks as needed.
- Ensure timely and complete data entry by site. Perform data review inclusive of site level data review, query resolution, facilitate database closure and freezing procedures as per study plans.
- Performs risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow up items and issue escalation.
- Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study-specific processes, local regulatory requirements.
- Manages additional clinical operations tasks as required and outlined in study job task list.
Experience and Qualifications
- Bachelor’s Degree Required, preferably in Science or Health Related Field; or, an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.
- Experience using computerized information systems and standard application software (Windows, MS Office).
- Excellent organizational and time management skills, with strong attention to detail.
- Exemplary communication, teamwork, and interpersonal skills.
- Superb resourcefulness, critical thinking, and problem solving skills with a solutions focus.
- Adaptability and ability to shift priorities as business needs change.
- Ability to quickly learn software and data systems that support clinical trial management.
- Read, write and speak English.
- To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
- 2+ years of work experience.
- Clinical trials support, data coordination or pharmaceutical industry experience.
- Office-based or clinical experience.
- Experience with electronic data capture, PC Windows, word processing, and electronic spreadsheets.
- Knowledge of ICH and local regulatory authority drug research and development regulations.
- Prior customer service experience.
- 3-5 years of relevant work experience.