Clinical Trial Specialist 3
PRA Health Sciences
Position is currently remote, but will require 2-3 days per week once COVID restrictions are lifted.
Are you looking to use your analytical, critical thinking, and communication skills? Do you enjoy solving problems, working with numbers and data to make a positive impact on clinical trials?
If so, we’d love to meet you.
Who are we?
We Are PRA. We are 17,000+ employees strong, operating in more than 90 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 are you?
- 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 Clinical Trial Specialist, 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 Clinical Trial Specialist 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).
- Performs essential document collection, review, maintenance, submission, notification, and close-out activities, ensuring client and investigator obligations are being met and are in compliance with applicable local regulatory requirements, ICH/GCP guidelines, and PRA SOPs.
- Liaises with internal and external stakeholders to meet project specific goals, prepares for and participates in investigator and client meetings as necessary, escalates project and site related issues per PRA SOPs.
- Manages additional clinical operations tasks as required and outlined in study job task list.
- Collecting essential regulatory documents from sites, and ensuring compliance with regulatory and ICH/GCP guidelines and PRA SOPs.
- Keeping the Trial Master File up to date with all relevant documents for the study, and monitoring document expirations.
- Working with Informed Consent Form updates, collaborating with sites on updates and ensuring appropriate IRB submissions and approvals.
- Working closely with internal study team to ensure all needs of the protocol, clinical management plan, and sponsor are met. Site related issues are escalated per PRA SOPs.
- Assists with resolution of investigational site data queries.
- Utilizing the Clinical Trial Management System (CTMS) to ensure subject status, site communications, site contacts, project information and institutional review board submissions are accurately tracked, current, and complete.
- Performing study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study. Works closely with cross-functional study team (CRAs, CMAs, CTMs, PMs, etc.
Experience and Qualifications
What do you need to have?
- Bachelor’s Degree Required, preferably in Science or Health Related Field
- 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
- MUST BE ABLE TO COMMUTE TO PRA OFFICE WHEN IT REOPENS
- 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 relevent work experience
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.
Apply directly online here.