Sharf Woodward & Associates
Clinical Research Associate
LOCATION: Boston MA (Contract) 18-24 months
Responsible for site management and performance (including documentation) of on-site monitoring (all types of visits) activities for multiple investigational sites in accordance with designated project assignments, (SOPs), Good Clinical Practices (GCPs) and applicable regulatory requirements.
SPECIFIC DUTIES AND RESPONSIBILITIES:
In conjunction with other Clinical Affairs team members, and working directly with outside investigators, participates in study execution, including:
Coordinating activities and clinical proposals of multiple outside investigators.
implementing clinical protocols.
Ensuring the quality of the collection of data from patient charts, medical records, interviews, questionnaires, diagnostic tests, and other sources; ensuring completeness and appropriate documentation.
Reviewing Case Report Forms (CRFs), Patient Diaries, Informed Consent (IC) forms.
Maintaining monitoring activities, including identifying non-conformity with protocol and recommending corrective and/or preventative actions and creating data queries.
Monitoring clinical study site compliance with device storage.
Tracking overall subject enrollment and progress to study completion.
Writing site visit reports, checking that reports are completed, and distributed in accordance with applicable SOPs and regulatory requirements.
Assisting with Serious Adverse Event documentation and routing to Sponsor.
Ability to react to change productively and to perform other essential tasks assigned. Contract position will require travel up to 85% which is the purpose of the contract position - to cover regional (Colorado EAST) study sites. In-house visits will be limited.
Time at site will depend on how many each site enrolls and how grouped together the enrollment is. Usually no more than 2 days and two nights at each visit.
BA/BS or MS degree in Life Sciences, Engineering, or health care-related discipline.
Certified Clinical Research Associate (CCRA) preferred
Three+ years of experience.
KNOWLEDGE, SKILLS AND ABILITIES:
Knowledge of clinical research procedures and FDA regarding the conduct of clinical research. Excellent organizational skills and attention to detail. Strong analytical, communication and interpersonal skills. Strong writing skills. Good knowledge of MS Office, Internet, databases, etc. Ability to work with minimal supervision in a busy field environment.
Great Company . Plenty of growth opportunities