SITE INVESTIGATOR/STUDY MANAGER

Diplomat Specialty Pharmacy
Michigan (Multiple Locations)

 At Diplomat Specialty Pharmacy, we offer unique disease-specific management programs that help keep patients healthier…longer.  At the core of each of these adherence enhancing programs is a team of experts devoted to patient care.  These teams include:  a personal patient care coordinator, a billing specialist, and a registered pharmacist.  Diplomat Specialty Pharmacy’s combination of innovative care, dedication and experience offers patients the highest level of service.  Our mission is to be a customer focused and innovative partner, providing medication management and clinical services in a caring, supportive environment; keeping patients healthier longer…one patient at a time.

Responsibilities

·         Monitor and document Informed Consent procedures.

·         Respond to and document inquiries from potential participants and the treating physicians.

·         Collection/Filing of Informed Consent Forms and other study site documents.

·         Correspondence with patients regarding instrument responses both written and electronic.

·         Track patient recruitment/enrollment.

·         Monitor and document data collection procedures:

                Resolve missing or out-of-range data.

                Tracking call schedules.

                Maintain comprehensive explanations of terminations.

·         Ensure strict adherence to the protocol and all applicable laws and regulations.

·         Identifying and reporting key study issues to Primary Investigator and monitoring authorities.

·         Assuring expedient reporting of Serious Adverse Event (SAE).

·         Correspondence with treating physicians regarding semi-annual reports

·         Participate in weekly Study Team Calls.

·         Participate in preparation of final study report for the IRB as directed.

·         Staff training.

·         Other duties as directed.

Required

·         Bachelors Degree (BA/BS) or RN, from an accredited college or university, preferably in a health or biological science field.

·         Certified Clinical Research Associate.

·         Minimum 3 years documented work experience in clinical research environment.

Preferred

Pharmacy experience of familiarity

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