Job Title: Clinical Research Associate (CRA)

Job Focus: Pharmaceuticals/ Monitoring medical research and clinical trials

Years in the Game: 10 yrs

Education: BS Biological Sciences

Whereabouts: That Silly Spot Silicon Valley

A clinical research associate releases her venom on the clinical world- office politics, differences between men and women, and why managerial positions are not the life.

Q&A:

Q. What do you find most challenging?

A. Dealing with people who are not seasoned or efficient in running trials. It takes patience; hand-holding is involved. Every couple of years the IRB (Internal Review Board) requires a renewal from sites so it knows that a particular study is still taking place and if it is doing well. Also, when the FDA makes a site visit, the study labs need proper documentation prepared. Readying the sites and staying prepared is challenging for these instances. We are not guaranteed the best coordinators- who actually should be nurses, but some come from retail jobs for example- so they don’t always know how to run proper protocol. Deadlines are also missed when the PI (Principal Investigator) at the site is overwhelmed or unaware of good practices. It’s also tricky when sponsors want data or documentation ASAP and the sites can’t help us with a quick turn-around. Merely being the messenger between the pharmaceutical company and the trial site doesn’t permit us to force them into satisfying the sponsor’s needs. Simple issues like document signing become problematic if they get returned to the sponsor without the right signatures. Another challenge is unknowledgeable managers at pharma’s (sponsors) who come up with unrealistic timelines for CRO’s to follow. For example, they’ll request “we need it today or tomorrow” when it realistically would take 1-2 weeks.

Q. What differences, if any, have you seen between men and women in the (biotech/pharma) work environment?

A. I used to think men were less political. Experience has revealed that men are just as political, manipulative, and even worse than the women in unethical, cutthroat conduct. I’ve seen a lot of men who will cover their ass if they screw up and still get promoted due to kissing ass. Many unqualified candidates succeed by being political and playing games. People in this field do what it takes to keep their position or get ahead. I’m aware of situations in which a promotion is given without merit and at short time frames because of a special relationship or connection to the boss. Also, because women are coming up in power positions men are being more obstructive. Unfortunately, ageism factors into our milieu at times. It’s disquieting to see young girls fresh out of college kiss ass instead of working hard. They get promoted to management by this fast track method instead of earning their positions. I’ve seen older women who play by the rules lose promotions. I used to think women were gossipy and men were more straight-up, but that is not the case here in the Silicon Valley. Women don’t always back up each other. One female employee was bullied because her female boss feared that she was smarter than her for holding a PhD.

Q. What’s the lowdown?

A. The public might find it scary that a significant number of the people responsible for managing clinical studies are not medical doctors or nurses. No one says anything about this upfront, but it needs to be voiced because biological scientists and researchers can do a better job. Also, some CRO managers don’t know what they are doing or talking about which adds so much incompetence to the system. These types of managers say to employees to go figure out their own problems because “I don’t know what I’m doing”. Many of them end up at sponsors because the pharma company needs “a warm body” to call a manager to run a study. A friend who is now in academia doesn’t want to return to industry because of backstabbing, politics, brown-nosing, and promotions based on manager-worker buddy rapports. In industry going to HR and the director sometimes doesn’t help to escape a tyrannical boss because their purpose it to cover the company and management. They might give you a lateral move to a different department, but you’re not getting that promotion if you speak up about something.

Q. Good boss/bad boss? How?

A. My boss is cool. She recognizes my work and accomplishments. She’s good because she doesn’t overload me. Actually, she doesn’t have time to make sure that we are overloaded. She recognizes hard work and doesn’t micromanage.

Q. How do you cope with issues that come your way?

A. Supportive managers and coworkers are needed to work with after 15hr days. My colleagues and I talk about pretty much everything and help each other. We discuss good and bad doctors, managers, and sites. Sometimes I need to leave a company. Other times I just trudge through, do my work, and hope to work with good people. The best way I found is to weigh the pros and cons and choose my battles.

Q. How do you balance work and life?

A. Per week, with travel, I work 55-60+ hours depending on how packed my travel schedule is. Questions I ask are: Can I take a vacation? Do I need to cancel it if they say I need to? You just hope to get lucky. Some ride it out in misery because they have financial responsibilities like a family to feed.

Hiss your way to The Toxicity of the Clinical World Part I: The Basic Sh*t.