Meet Wen Li, a Clinical Research Associate II

What is it like to work as a Clinical Research Associate?

Clinical Research Associate (CRA) is responsible for monitoring clinical trials on behalf of Sponsor. CRAs visit hospitals (sites) to ensure that clinical trials are conducted in accordance with protocol, regulations and guidelines. During these visits, CRAs will cross check data entered in case report form (CRF) against medical notes to ensure data entered by site is accurate and reflects actual source at site. CRAs will also check on investigator site files, Investigational Product (IP), study supplies and meet site staff (Investigators and study coordinators) to discuss/ train site staffs about study updates. After each visit, CRAs will prepare detailed report documenting issues identified/ resolved during the visit.

On days where we are not on-site, we will be managing sites remotely. These tasks might include preparing Ethics Committee submission, managing site payment, training sites remotely, etc. We spend a significant amount of time travelling, so we will usually work from site, hotel, airport and home!

What are the departments/positions GCO team collaborating with most frequently? 

Within GCO, CRAs work closely with Clinical Operation Associate (COA), initiation CRA (iCRA) and regional Clinical Operation Lead (rCOL). We also work with Data Management team for data cleaning, Regulatory Affairs (RA) team for regulatory submission and Clinical Trial Supply & Logistics (CTSL) team for study supplies related matters.

Can you share the Career Development chances in clinical operation team? How has Parexel supported your career growth?

Senior CRAs can choose to advance to project management team (e.g. COL) or to manager roles. Otherwise, Parexel supports career growth within department and across functions.  We do have colleagues from GCO team that joined Site Contract team or colleagues from GDO that joined GCO. Parexel organizes internal career fair annually, where we can connect with various department and explore area for professional development. As we develop more skills and experience, we are encouraged to try out roles among the organization.

What kind of advice you’d give to people who’d like to join CRA team?

Make use of online resources to know more about Clinical Research Industry and Good Clinical Practice (GCP) by completing free training courses!  Gain clinical trial related experience as a study coordinator or clinical operation assistant. Alternatively, you can look out for CRA development programs that allows transition to CRA after certain period of training.

What do you enjoy outside of work? What is something most people don't know about you that would surprise them?

I enjoy a variety of sports and music outside of work! I usually spend my free time lifting weights, doing Pilates, yoga, singing, painting etc.

How would you introduce the job of clinical operation team? How does Clinical Research Associate team functions in the clinical research cycle?

The Clinical Operation (ClinOps) team is responsible for conducting clinical trials in accordance with the clinical development plan. CRAs play a crucial role in maintaining rapport with site as we are site’s main contact. CRAs collects all questions/ concerns from site and help resolve or escalate them accordingly.

How is Parexel/CRO industry different from the other industry/positions you had worked with?

I worked as a study coordinator (SC) previously in a Site Management Organization (SMO). Unlike CRO, SMO specializes in site operations. SCs are site staffs stationed in hospitals where clinical trials are being conducted. SC facilitates conduct of trial (e.g. scheduling patient visit and conducting study procedures, etc.) while CRA monitors trial done at site. Both SC and CRA job requires one to be organized and meticulous. It requires great empathy and compassion to be a good SC since SCs interact directly with ill patients, whereas a good CRA should possess strong problem-solving, communication skills and always be attentive to details. 

Can you share the training provided at Parexel?

Our CRA onboarding training program includes 1 week of instructor led online training that covers main responsibilities of a CRA. Onsite training (e.g., tagging along seniors/manager to observe how visits are conducted) can be expected. Online trainings for Parexel’s systems and company SOP should be completed as well. Project specific trainings should be also completed via our learning portal. Parexel provides optional “Lunch & Learn” training sessions, where we can register for any topics that sparks our interest during lunch hours. Around 6 new topics ranging from “latest treatment options for specific disease” to “yoga classes” will be covered every month.

How do you use Parexel benefit and what are the best part of it?

Parexel utilizes Bravo Rewards and Recognition Platform, where our hard work can be recognized and rewarded via “Bravo” points. We can exchange vouchers, gift-cards, household appliances, electronic devices etc. using our bravo points. I got myself a Nintendo Switch OLED Console using my “Bravo” points!