Medical Research Associate (Serious Adverse Events): WORK-LIFE BALANCE With Limited Travel

Our client, based in the Boston area, is recognized as a leader in the biopharmaceutical outsourcing market with their commitment to providing solutions that expedite time-to-market and peak market penetration.  As a Contract Research Organization (CRO) they have developed significant expertise in clinical trials management, biostatistical analysis, medical marketing, data management, clinical pharmacology, regulatory and medical consulting.

 Directive

Reporting to the Medical Safety Manager, the function of this position requires a solid working knowledge of medical terminology and standard medical practice.  The primary directive of the Medical Research Associate is to report Serious Adverse Event information effectively to clients, investigator site staff and colleagues. 

 

 Responsibilities 

? Partner with Medical Monitors in the reporting of serious adverse experiences in clinical trials

? Assist MDs in the drafting, writing, and editing of protocols and CRFs for submission to clients, in conjunction with the Medical Writing Services Group

? Interface with Medical Directors, as well as the following teams: project management, clinical research, data management, medical writing, and regulatory

? Review and research patient case report forms (CRFs) and SAE reports

? Make telephone inquiries to study sites to obtain any urgent additional information required to prepare and file reports/maintain written telephone reports

? Direct inquiries to site staff through CRAs and maintain records to verify follow-up was taken

? Review adverse experience forms from the site.

? Assist Medical Writers in adverse experience narrative writing

? Assure that adverse experience reports are transmitted in a timely fashion to the client, CRAs, and central files

? Alert database managers to any updated or corrected information obtained in subsequent reports, including follow-up confirmation of updates

? Work cooperatively with project management to ensure timeliness of adverse experience reporting and client satisfaction

? Work with Project Manager to assure regular updating of project central files

? Devise and maintain project specific North American Medical Services working files

? Assist BDM in the reconciliation of SAE data and the clinical CRF data

 

Qualifications

? BA/BS in health-related field; prefer BSN, RPh, or PharmD degree (or equivalent work experience)

? 4 years related experience and 2 or more years pharmaceutical clinical trial monitoring

 

Characteristics

? Ability to interpret and apply new knowledge regarding disease entities and pharmaceutical development as related to specific clinical trials

? An ongoing interest in medicine, pharmaceuticals, and regulatory affairs is essential for maintaining quality performance in this position, and continuing education in these areas is encouraged

? Ability to research information and prepare written documents

? Excellent interpersonal, communication and writing skills

? Strength in database management skills and computer applications 

 

 Benefits

Health, Dental, Life Insurance

Short Term/Long Term Disability Insurance

401K/Matching Program

Employee Stock Purchase Plan

Tuition Reimbursement