RESEARCH ASSISTANT I

Affiliate Name: Brigham & Women's Hospital
Job Category: Research
Department: BWH PREVENTIVE MEDICINE
Shift: Days
Hours/Week: 1
Job Type: Regular
Employment Type: Full TimeResponsibilities:
Responsible for providing primary telephone coverage for calls to and from up to 120 U.S. clinical sites enrolling and following 800 subjects in a large, randomized, placebo-controlled clinical trial testing injectable insulin with or without metformin pills in treating Type 2 diabetics. Involves answering protocol questions, organizing re-supply of study drug and other study materials at site request, randomizing subjects using computer programs to assure correct drug is dispensed, and bringing any issues to the attention of appropriate study staff. Also will review incoming data forms via a split screen fax system for completeness and accuracy and generate appropriate edit queries.1. Primary responsibility for answering incoming calls from study sites, triaging questions and issues appropriately, documenting questions and outcomes as appropriate, and assuring prompt follow-up including drafting response correspondence.
2. Responsible for one of two split-screen reviews of all incoming data collection forms. This task replaces double entry of data and requires a higher level of understanding of the protocol and a thoughtful review process to assure that illogical, unclear or inconsistent data are flagged and that clear edit queries are generated for fax-back to the sites.
3. Phone coverage responsibility includes performing randomization of subjects at sites, assuring that eligibility criteria are met to prevent mis-randomizations, and that correct supply of study drug is dispensed to each randomized subject from the site supply.
4. As primary phone person, responsible for proper handling of reported Serious Adverse Events from sites. Requires immediate notification of supervisor/study physician on duty so that proper medical records are retrieved from the site in a timely way since the event may require notification of the funding sponsor, IRB and FDA.
5. Other duties as assigned.
REQUIREMENTS
1. BS or BA
2. Computer literacy1. Excellent reading, writing and reasoning ability in order to understand and articulate the objectives and methods of a complex clinical trial.
2. Excellent interpersonal skills to deal effectively and professionally over the phone with a diverse group of busy, private practice investigators who are physicians and nurses at the recruiting sites as well as with in-house staff who are at all levels, from senior faculty/clinicians to study and Division staff.
3. Excellent problem solving and priority setting skills.