Site Management Associate
- Experience Level
- Experienced (non-manager)
Who are we?
We Are PRA.
We are 20,000+ employees strong, operating in more than 95 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
Who You Are:
You are known to friends as the “go-to” person. You have excellent communication & follow-up skills. With your commitment to executing projects in accordance with the highest standards, you hold a certain reverence for delivering accurate and quality work in a timely fashion. But most of all, you are someone with tremendous potential who wants to apply your many talents in a role that will expand your fundamental knowledge of clinical research and provide you with the options and training to continue to grow in your career.
What will you be doing?
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.
What do you need to have?
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
1+ years of professional work experience in an office or medical/ dental setting preferred (Level 1)
Clinical trials support, data coordination, pharmaceutical industry, medical/ dental assistant, scientific study or research setting preferred
Office-based or clinical experience a plus
Experience with electronic data capture, PC Windows, word processing, and electronic spreadsheets a plus
Knowledge of ICH and local regulatory authority drug research and development regulations a plus
Prior customer service experience preferred
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.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.