Karen Woodin, Ph.D., who passed away Feb. 8 after a long and distinguished career in the clinical research industry, is described as thoughtful and astute, with a blend of academic and artistic talents. Known widely for authoring two industry guides, her dynamic career also included a 20-year tenure at Upjohn and many years as a workshop leader, teacher and director of the Drug Information Association (DIA). She was 74 years old.

Friends and acquaintances remember her humor, intelligence, vibrant dinner conversations, cooking competitions with her husband John Kapenga, natural teaching skills and love of learning. She also had a personal motto: “Nice Matters.”

When Karen entered college she faced discrimination over her choice of major. “Karen, who was at the top of her high school class in math and science, was told by her college advisor at Western Michigan University during her first interview that she could not major in math, as that was a field for men—and directed her to be an art major, which she hadn’t ever thought about,” said Kapenga. “Luckily, that changed for her several years later.”

Friends marveled at her ability to zig-zag academically, Karen following that art degree with a degree in biostatistics—both from Western Michigan University—and a Ph.D. in epidemiology from the University of Massachusetts.

“She was a superb collaborator,” recalled John C. Schneider, who met Karen at Upjohn and with her co-authored The CRA’s Guide to Monitoring Clinical Research, published by CenterWatch and now in its third edition, which has become essential reading in the field.

She also is known as author of CenterWatch’s The CRC’s Guide to Coordinating Clinical Research, now in its second edition.

“The idea for a book came up while we were traveling for business and had long layovers at one airport,” said Schneider, who knew Karen for 40 years. “We were sitting in the lounge talking and she said there was really no good text out there for clinical research monitors. I agreed, and we continued the conversation about coming out with a science book for these folks. Karen also was good friends with Ken Getz (founder and owner of CenterWatch), and he agreed, after we provided him with a rough outline. He thought a comprehensive clinical trials book was marketable and assigned us to an editor.”

Getz recalled that Karen, who became one of CenterWatch’s top book authors as well as a good friend, brought with her the highest level of professionalism and integrity, along with unprecedented organizational and communications skills and wit.

“She had a terrific sense of humor and was always fun to be with,” said Getz. “At holidays and important family events, Karen would send thoughtful cards and notes, often with handdrawn illustrations and caricatures. When my kids were little, Karen made a point of sending illustrations that my children could color in.”

Schneider said collaborating with her worked well because they had common interests and agreed on the state of clinical trial monitoring, based initially on their Upjohn experiences. The resulting book filled an immediate education text void, which led to the two teaching classes in clinical research, techniques and methods for monitoring trials.

Her work at Upjohn started when Robert (Bob) Assenzo hired her to revamp the CRA group run by former sales managers. He wanted more scientists in the group. She later managed the field monitors.

“She knew how to pick people who could follow a protocol, enroll patients in a way that met the requirements of the protocol and knew clinical trial time limits,” said Assenzo, who later became DIA’s executive director, which led to Karen becoming a DIA board member.

“Wonderfully bright, very astute, good at handling people and an ability to understand the scientific needs of the protocol and improving trial design,” said Assenzo. “Frankly, I am still upset by her death and really miss her, as we stayed in touch for a very long time.”

Karen’s CRA leadership and value to Upjohn led to another collaboration: co-developing the academic program in Clinical Research Administration at Eastern Michigan University with Schneider. She also taught at the university, which still uses her textbooks.

“I am not sure whether the texts with John Schneider evolved from their program development activity or whether the program evolved from developing the texts, but given the small number of good texts for new CRAs and CRCs, the mesh gives students and faculty a wonderful platform for learning,” said Stephen A. Sonstein, Ph.D., director of clinical research administration at Eastern Michigan University.

Sonstein also had Karen videotape her lectures for the school’s online master’s program in clinical research administration, which also is offered at several other schools.

“Students continue to benefit from her efforts, and there are innumerable clinical trials being conducted and monitored by highly skilled professionals due to the abilities and enthusiasm of Karen Woodin,” he said. “I will miss her very much.”

Karen was a natural academic who could use her humor to ease students in her DIA workshops, recalled Liz Moench, president and CEO of Medici Global, a recruitment firm that matches patients to clinical trials. The two worked side by side helping DIA evaluate how to optimize those workshops within the industry to get the best attendance and provide quality education.

“She was a gentle soul and an incredibly thoughtful woman,” said Moench. “I can remember many a dinner when we laughed, while most people saw her as a very serious person. In groups, she spoke out and did not speak just to be heard. She often contributed some of the best thinking in a group. She never did anything half way. I can still see her sitting at a meeting as a reminder that we, after 30 years, are part of an incredible breed of industry veterans.

Email comments to Ronald at ronald.rosenberg@centerwatch.com. Follow @RonRCW

This article was reprinted from Volume 19, Issue 07, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »