Study Start Up - Site Activation Associate
- Experience Level
- Experienced (non-manager)
Who are you?
Whether you are a new graduate, a clinical research professional with several years of study start-up experience under your belt or a refugee from another industry, looking to make your home in the CRO space, you are known to friends and colleagues alike as the “go-to” person. You are the subject matter expert in your field, and yet, people contact you with questions that fall outside your jurisdiction because they know you will leverage every resource you have to get them the answers they need.
You have excellent communication & follow-up skills, you dot your “i’s” and cross your “t’s,” and there’s just something about tasks that tap into your innate process orientation that make your heart go pitter-patter. With your commitment to executing projects in accordance with the highest standards, you hold a certain reverence for the regulatory processes, SOPs and document trails that map out a pathway to compliance. 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 SAS, you are the primary point of contact/liaison for the sites, Sponsor and internal stakeholders during the study start-up process. You will perform investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and 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. Senior-level SAS/Lead will manage all activities listed above, ensure that they meet Sponsor & PRA expectations, and deliver them in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.
What do you need to have?
- Minimum 1 year of study start-up or related experience and HS diploma required
- MSc degree is preferred
- Experience using computerized information systems and standard application software (Windows, MS Office)
- Excellent written and oral communication skills
- Knowledge of ICH and local regulatory authority drug research and development regulations preferred
- Clinical trials support or pharmaceutical industry experience strongly preferred
- To qualify, applicants must be legally authorized to work in EMEA, 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.