Clinical Rsch ProgProj Mgr

Bachelors degree required; a Masters degree is preferred.

A minimum of 5 years of progressively responsible experience is required

Some managerial experience is preferred.

Experience in health care academic research pharmaceutical industry public administration or social sciences preferred. The position depends on knowledge of industry standards including Internal Review Board practices and HIPAA compliance guidelines.

Project Manager must be skilled in computer and data management systems including Microsoft Office applications. An understanding of basic statistics and epidemiological principles is essential.

The Project Manager position functions with a high degree of independence under minimal supervision. The position involves a high level of interaction with the Research Assistants each day and weekly with the Director and the Epidemiologist. Requires the ability to develop constructive and cooperative working relationships with others and maintain them over time. Candidate must possess the ability to work with individuals from various fields of expertise and different levels of education and background and the ability to handle sensitive and confidential information.

Candidate must have the ability to work on a team prioritize competing tasks multitask meet deadlines take initiative and hold self accountable. Should be service oriented and interested in helping others.

90 of work is conducted in office environment. Minimal travel is required.

Position supervises 2 FTE and is responsible for weekly timekeeping and tracking of earned time.

The Project Manager is in charge of all activities of the North American AED (antiepileptic drug) Pregnancy Registry. Founded at this hospital in 1997 over 10000 pregnant women taking one or more of these have been enrolled. The continuing goals are to work with these enrolling pregnant mothers to determine the frequency of birth defects and harmful effects on growth in the antiepileptic drugexposed infants. Pregnant women throughout the U.S. and Canada are eligible. An unexposed comparison population is enrolled as well. The Project Manager supervises two Research Assistants (RA) who interview the enrolling women during pregnancy twice and once when the infant is 8 to 12 weeks old. She/he works closely with the Director (Lewis B. Holmes M.D. Professor of Pediatrics at Harvard Medical School) and the Epidemiologist (Sonia HernandezDiaz M.D. Ph.D. a Professor of Epidemiology at the Harvard School of Public Health) in conducting studies of the potentially harmful effects of each of 30 or more and improving the methodology of this pregnancy registry. These pregnancy registries are a new method for identifying the potentially harmful fetal effects of medications like antiepileptic which must be taken by pregnant women with chronic diseases.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

PROJECT MANAGEMENT

The Project Manager (PM) supervises the computer assisted telephone interviews (CATI) by the Research Assistants with 30 to 40 new enrollees each month and 5 unexposed controls in addition to followup interviews with current enrollees. The PM will help new Research Assistants to develop effective methods for connecting with the women who call the Registry to inquire and hopefully enroll. (A woman must call to enroll; her physician or nurse cannot enroll her. The PM will continue ongoing studies to improve the effectiveness of the Registry such as determining the reasons why 1 in 3 enrolled women are reluctant to provide her written permission to obtain the relevant medical records of either her or her infant. The PM will organize the adjustments made periodically in the questions asked and in the way that information is compiled.

The PM works with the Registrys experienced Programmer to make changes in the CATI interview protocol. The PM works with the Epidemiologist to organize period tabulations of the findings for specific and enrollment rates.

ANNUAL PRESENTATIONS

An annual Report is developed each spring by the Director Epidemiologist and PM to be sent to each of the seven manufacturers of AEDs which are Sponsors of the Registry. These reports present the specific findings since 1997 for each of 10 to 12 specific anticonvulsant . This is a collaborative effort by the entire Registry team.

An Exhibit of the Registry is taken each year to be presented at the annual meeting of the American Epilepsy Society in early December. This is a fourday event for the PM one RA and the Director. The Exhibit is visited by many neurologists who have recommended to their eligible patients to enroll in the Registry. It is an important opportunity for communication with an important source of support and encouragement to enrollees.

The PM Director and Epidemiologist organize the Annual Meeting in May or June each year. The Registry staff represent the current status of the Registry to the members of the Scientific Advisory Committee and the Steering Committee which includes representatives from each sponsoring company. The PM is responsible for the logistics of this oneday meeting as well as for describing the current status of enrollment and advertising.

ADVERTISEMENT AND MARKETING

A continuing system of providing feedback to referring physicians and nurses has been developed with regular adjustments expected. An annual newsletter that focuses on issues of interest to the enrolled women is organized by the PM. New efforts using social media such as Facebook and Twitter are being developed and will be the responsibility of the PM and the Research assistants. A creative approach to developing new methods of advertising is encouraged

RESEARCH

Studies are underway on several aspects of the Registrys findings. The PM is invited to participate in these projects. Previous publications are listed on the website: www.aedpregnancyregistry.

REGULATORY COMPLIANCE

Corresponds with the Internal Review Board (IRB) for approval of protocol notice of adverse events continuing review and submission of all amendments. Assists the Director with meeting all deadlines and reporting requirements. Identifies organizes and ensures accurate completion of required regulatory documents. Guarantees HIPAA training of all Registry staff. Prepares amendments to protocols and/or modifications to study design as well as yearly continuing review submissions. Serves as primary intermediary between Principal Investigator and IRB. Oversees reporting of Adverse Events to manufacturers.

PERSONNEL MANAGEMENT

Arranges job posting directs recruitment screening interviewing selection and placement for all Registry employees. Interviews and recommends qualified candidates for open positions. Conducts reference checks. Handles orientation and training for new hires. Assesses staff training requirements plans/administers training and supervises training of staff. Completes periodic performance evaluations of the Research Assistants.