Clinical Research Coordinator II

Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills perspectives and ideas we choose to lead. Applications fromprotected veterans and individuals with disabilities are strongly encouraged.

The Clinical Research Coordinator II will be responsible for assisting with all project management activities related to conducting multicenter clinical trials for the Tearney laboratory.

The clinical research assistant will also be responsible for study monitoring and will travel to sites to perform study monitoring visits.

Maintains research data patient files regualatory binders and study databases; Performs data analysis and QA/QC data checks

May develop systems for QA/QC

Organizes and interprets data; Independently judges suitability of research subjects; Develops and implements recruitment strategies

Act as study resource for patient and family members as needed

Monitors and evaluates lab and procedure data

Administers scores evaluates study questionnaires

Assists with preparation for annual reviews

Assist with preparation of study reports

Assist with the management of protocols including updates and amendments

Assist with the preparation of consent forms and maintains revisions

Assist with the creation of case report form documents

Organize required documentation from study sites for the conduct of the studies including biographical materials other support IRB approval letters approved consent forms and institutional material

Assist with the preparation of agendas and logistics of the training/review meetings

Assist with the monitoring of enrolling site performance for subject accession and data acquisition in accordance with the protocols

Document reportable events and other major concerns related to the studies Assist with development of computerized databases for each new study.

Review data forms for legibility completeness and ambiguity.

Assist with the preparation of reports for safety monitoring committee.

Travel to sites to review case report forms and regulatory documents Accept responsibilities for special projects as requested.

SUPERVISORY RESPONSIBILITIES: May assist with training and orientation of new clinical research assistants

Bachelors degree required.

Minimum of 2 years clinical research related experience.

Good working knowledge of federal regulations and ICH/GCP Guidelines required.

Prior clinical trial and monitoring experience preferred.

CRP certification preferred

Must be able to function independently and make effective decisions.

Must demonstrate excellent judgment and aptitude in problem solving.

Must have strong organizational administrative and time management skills.

Must have excellent oral and written communication skills as well as interpersonalskills with ability to interact professionally at all levels.

Excellent judgment and an ability to maintain confidentiality.

Must have prior clinical trial experience with financial management background.

Must have extensive working knowledge of NIH funding policies and FDA regulations.

Ability to work both independently and as part of a team is essential.

Must have GCP training and experience in clinical trials research experience working with IRBs / Ethics Committees and regulatory agencies

Good working knowledge of CFR (Code of Federal Regulations) and ISO requirements.IRB and FDA communication experience required

Ability to travel independently to offsite locations.

The clinical research coordinator II tasks will take place on the 6th floor of Bartlett Hall at the MGH. Some travel will occur to monitor clinical sites.

Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills perspectives and ideas we choose to lead. Applications fromprotected veterans and individuals with disabilities are strongly encouraged.