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Field-Based Employees: The Clinical Research Career Ladder Exists for You, Too


Question: How does an ex-postdoc, based in the north of England and unable (or unwilling!) to relocate to the south, embark on a new career, with prospects and job satisfaction?

Answer: Stay in the north and get into clinical research. Interested? Then read on.

I joined a small, Berkshire-based clinical research organisation (CRO) in 1994 as a field-based clinical research associate (CRA), working from home in Newcastle Upon Tyne. I worked long hours, driving over 20,000 miles a year, to visit investigators (general practitioners and hospital consultants) based across the north of England and southern Scotland. Although the work was not mentally taxing, the attention to detail and interpersonal skills required kept boredom at bay--initially. But, I had greater ambitions, despite being tied to living in Newcastle because of my husband's job in the Northumbria Police Force.

At the time, CROs did not employ field-based clinical project managers (CPMs). The feeling was that this job could be properly performed only in-house. My salvation was a supportive middle manager who realised my potential, coupled with my being a noticeable cog in a small company machine. I helped develop company standard operating procedures, and as one of the few Ph.D.s, I wrote all the manuscripts for publication for which the medical writing team landed contracts.

At the time, the company was undergoing changes at the senior management level. All I needed was a progressive senior manager willing to pilot a field-based CPM job. When the likely candidate arrived, I met him at the earliest opportunity, armed with a list of initiatives I had introduced and implemented since joining the company. Backed by middle management, the position of field-based CPM was born, albeit for a 6-month trial period and with the proviso that I was initially promoted only to the level of senior CRA. Success in the job would bring the substantive job title and salary to match the in-house CPMs after 6 months.

The challenging and diverse CPM role combined scientific knowledge with project management skills. Once a clinical trial contract from a sponsoring pharmaceutical company was secured, I assembled my project team. This consisted of CRAs based around the country and responsible for overseeing the investigational sites, in-house data managers, and a project statistician. I was involved in writing the trial protocol (following an appraisal of the scientific literature and in consultation with the statistician, sponsor, and principal investigator), selecting a panel of eminent investigators to conduct the research, visiting each site to ascertain suitability and capability for myself, compiling complex ethical applications for the conduct of the trial for each investigator's ethics committee, and training the investigators and CRAs in the background to and conduct of the trial. This was done at investigator meetings, hosted by my team, with the sponsoring company present.

This busy start-up period for all studies was followed by a period of intense activity in devising new documents, spreadsheets, and forms to facilitate the smooth running of the trial. On ethical approval, the investigational sites were activated, study drug supplies despatched, and onsite training performed. It was now up to the investigators to deliver their quota of study patients and up to me to drive the study to conclusion within the given time frame.

I oversaw all the paperwork relating to the CRAs' monthly site visits, put together monthly newsletters to keep the investigators informed, dealt with the sponsoring company, and generally kept the "machine" well oiled. Delivery of the required number of patients by the closedown date was of paramount importance. Once all the data were collected in-house, my role shifted to primarily dealing with the data managers and statistician. Following endless meetings, the database could be locked. The statistician then worked "stats magic," and, if the contract allowed, a company medical writer wrote the integrated clinical study report.

CPM job diversity was probably more wide ranging in the CRO environment at the time compared with the large pharmaceutical companies, where additional staff resources were less of a problem and many of the (CRO) CPM's duties would naturally fall to, say, a person allocated a given task who oversaw that task for a whole group of studies. In short, the CRO environment was (and still is) a hard-and-fast training ground, where the full range of project management skills is learned quickly. I regularly worked a 60-hour week, particularly when multiple studies were going on simultaneously. I was made a substantive CPM and opened up field-based project management for others like myself who did not want to join the rat race "down south".

Life for me moved on, and I became pregnant in June 1998. A few months into my pregnancy, I realised I couldn't keep up this pace of work and travel and also look after myself and the baby properly. The company offered me the position of medical writer at the same salary level, and with the option to work part-time on my return from maternity leave. My flexibility and willingness to respond to the growing company's changing needs was rewarded at just the right time.

I returned to the medical writing department as a senior medical writer in September 1999, working from home 4 days a week. Since having my second child in October 2001, I have been promoted to clinical scientist, and this is the position I will take up on my planned return to work, part-time, in May 2002. This is largely an enhancement of the medical writing role: It formally acknowledges the mentoring of more junior writers and the leading of writing teams that I had undertaken as a medical writer.

The roles of both medical writer and clinical scientist include producing integrated clinical reports, manuscripts for publication, and occasional marketing articles. Regulatory writing is also required, on occasion, to support a stretched regulatory department. Manuscript preparation, front-ending reports, and pulling together discussions are among the most interesting parts of the job for me. These activities allowed me to draw on the library research skills I learned during my Ph.D. and postdoctoral years and help cement a firm science foundation by expanding my knowledge in diverse therapeutic areas. The balance is perfect for me at this time in my life. I exercise the grey matter for 4 days a week, but I am always here at the end of each day after nursery for my children. Tight sponsor deadlines mean it would not be feasible to do my job in less than a 4-day week. Quarterly visits to the head office for a couple of days at a time provide a refreshing break for me and have the added effect of making me appreciate not having to live life at that pace every day.

As for working from home, career structure is possible. There are two further opportunities for promotion beyond the position of clinical scientist. Relationships with work colleagues can be developed and nurtured, with a little effort. I am often asked how I cope with being on my own all day. The working day flies by, but I would add that interests and friends outside the home are essential parts of making it work.