Senior Research Assistant Gastroenterology

The Senior Research Assistant works with the research study investigators to coordinate subject recruitment, clinical data, study related communications, and IRB submissions for designated projects. The candidate will oversee the clinical research through all stages such as IRB Submissions, maintaining Regulatory, Patient Recruitment and successful execution, study Monitoring, Sponsor invoicing for milestones completed and study Close-out.

The Senior Research Assistant is responsible for evaluating and tracking the recruitment process including outcomes, expenditures, and reporting to investigators on outcomes related to study progress. The assistant must conduct all study related activities according to HIPAA and IRB guidelines.

Additional responsibilities include working in close contact with local gastroenterologists, Partners' Institutional Review Board (IRB), and fiscal/legal groups within and outside of Partners, as necessary. Excellent communication (oral and written), phone, and computer skills are necessary.

Working independently and under general supervision from the study investigators, provides support to clinical research studies. May be responsible for the following activities: developing and implementing strategies for improving study logistics and execution, recommending changes to protocols, and completing administrative duties such as Sponsor invoicing for study milestones completed.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

1.Maintains study systems to execute protocols,

2.Recruits and enrolls subjects,

3.Coordinates communication among PI, subjects, and parties associated with study protocol

4.Maintains and/or assists in subject characteristics database,

a. prepares reports

b. enters data as needed in eCRFs

c. uses database searches for recruitment activities,

5.Understands general study protocols and inclusion criteria for ongoing studies,

7.Tracks and characterizes responses and expenditures for all recruitment and subjects modalities, sends invoices to the sponsor for completed milestones

8.Prepares and presents data reports for investigators, study monitors, IRB and research collaborators.

9.Coordinates all study IRB submissions with Principal Investigator and Partners IRB,

10. May assist in coordinating lab activities such bio-safety and equipment quality assurance.

11. Performs all other duties as assigned

QUALIFICATIONS:

1.At least two years related experience in a clinical research environment

2.BA or BS required

3.Proficiency with Microsoft Office Suite

4.Sound independent judgment and competence in research methodologies