LEAD CRA / Lead Clinical Research Associate – Infectious Disease

Job Description:
Assist the Director of Clinical Development in the Management of multiple clinical and non-clinical trials. Assist with the management of CROs, and investigational site personnel to assure adherence to Good Clinical Practices (GCPs).

Essential Duties:

Manage all aspects of CRO relationship(s), including, but not limited to: pre-study site assessment, regulatory document collection, site initiation, patient data monitoring, drug accountability, and site closeout
Manage all aspects of clinical, and non-clinical, studies, including coordinating multiple investigative sites with CROs and managing all aspects of studies that are not delegated to CROs by (Company)
Coordinate interaction between Regulatory Affairs and Clinical Development to maintain regulatory files for IND submissions, IND Annual Reports and Safety Assessments
Preparation of study procedural manuals, investigator notebooks and other documentation required for the study
Maintain contact with CROs and sites to ensure adequate regulatory compliance and provide feedback regarding site performance
Address performance concerns/problems with specific sites as needed. Follow up to ensure problem resolution
Present timely reports / updates for ongoing trails to peers, supervisors, and external parties, e.g., Investigator meetings

Other Duties:

Assist in preparation of Regulatory submissions (INDs, IND Annual Reports, Safety Updates, NDAs, CTDs), Investigator Brochure updates and protocol writing.
Approximately 25%-30% travel required
Other duties as assigned.
REQUIREMENTS
Job Qualifications:
2-3 years experience in clinical research or related field (Regulatory Affairs, Quality Assurance, Nursing)
MUST have at least 1 year FIELD monitoring experience
BS/MS or equivalent in relevant scientific or medical field (e.g. nursing)
Ability to Multi-task and establish priorities for study conduct and work with little or no supervision
Self-motivation, flexibility, and outstanding written and verbal communications skills mandatory
Knowledge of Basic clinical science, preferably in infectious diseases
Knowledge of FDA regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
Knowledge of Microsoft Office (Word Excel, MS Project, PowerPoint, Access, and Outlook) at an intermediate level of proficiency required
Knowledge of infectious disease and infectious disease treatments is a plus

Compensation:
70,000 – 85,000 (commensurate with experience)
Some relocation reimbursement offered (if necessary)

Location: New Haven, CT area

Company Information:
Our client is a growing pharmaceutical company with 2 products in clinical trials, and a third in the pre-clinical stage, which makes them quite unique for a smaller organization. This is a strong opportunity with lots of potential for internal growth as the company provides a great learning experience and environment, and management aims to help move people’s careers forward.

Please forward your resume in a Word document via email to [Click here for email].

View additional job opportunities available through our company on www.mrwg.com