Senior Clinical Research Associate East Coast
Position
Summary: Key player in managing start up activities at study sites in the Eastern United States for Autonomic Technologies. Coordinate and perform comprehensive site management utilizing Good Clinical Research Practice (GCRPP) to assure optimal compliance. Responsibilities will include clinical protocols including telephone contacts and conduct and documentation of pre-study, initiation, interim and closeout site visits at investigator sites
Essential Functions:
Manage Site start-up activities including but not limited to contract and budget negotiations, IRB communications and study/site initiation, patient recruitment strategies and timelines.
Monitor study sites including but not limited to checking Investigational Product supply, site compliance with protocol and all current and relevant regulations, conducting source data verification, ensuring all serious adverse events (SAEs) have been reported appropriately and providing written follow-up requests to the site in order to correct any issues identified at the monitoring visit.
Monitor patient recruitment timelines at sites, develop strategies to increase patient enrollment (eg investigator and research nurse meetings, newsletters, advertising, letters to GPs).
Assist with arranging of project kick-off meetings if requested
Assist with the conduct of ongoing project team meetings (either face to face meetings or teleconferences, depending on the location of the team members), if requested
Review draft protocols for completeness and feasibility
Develop Case Report Forms for clinical trials
Comply with Autonomic Technologies' quality system requirements as well as applicable regulatory requirements
Other duties, as assigned
Knowledge and Skill Requirements:
Bachelor's degree (in life sciences, RN, BSN degree preferable) or equivalent with a minimum of 5 years related experience in supporting medical device clinical trials. Implantable medical device experience a plus.
Experience with Electronic Case Report Form interfaces is desireable.
Excellent knowledge of GCRP CFR, GCP, local regulations and internal procedures required for clinical trials.
CCRA Credential or equivalent from a recognized Clinical Training Organization such as Association of Clinical Research Professionals is desirable.
Proficiency in Microsoft Office Suite
Strong verbal communication and scientific writing skills
Must exercise good judgment regarding routine and non-routine assignments; excellent time management, organizational and interpersonal skills.
Experience initiating Clinical Trials desirable
Travel within North America will be up to 75%. Will be working out of home office
Estimated Salary: $20 to $28 per hour based on qualifications.
Summary: Key player in managing start up activities at study sites in the Eastern United States for Autonomic Technologies. Coordinate and perform comprehensive site management utilizing Good Clinical Research Practice (GCRPP) to assure optimal compliance. Responsibilities will include clinical protocols including telephone contacts and conduct and documentation of pre-study, initiation, interim and closeout site visits at investigator sites
Essential Functions:
Manage Site start-up activities including but not limited to contract and budget negotiations, IRB communications and study/site initiation, patient recruitment strategies and timelines.
Monitor study sites including but not limited to checking Investigational Product supply, site compliance with protocol and all current and relevant regulations, conducting source data verification, ensuring all serious adverse events (SAEs) have been reported appropriately and providing written follow-up requests to the site in order to correct any issues identified at the monitoring visit.
Monitor patient recruitment timelines at sites, develop strategies to increase patient enrollment (eg investigator and research nurse meetings, newsletters, advertising, letters to GPs).
Assist with arranging of project kick-off meetings if requested
Assist with the conduct of ongoing project team meetings (either face to face meetings or teleconferences, depending on the location of the team members), if requested
Review draft protocols for completeness and feasibility
Develop Case Report Forms for clinical trials
Comply with Autonomic Technologies' quality system requirements as well as applicable regulatory requirements
Other duties, as assigned
Knowledge and Skill Requirements:
Bachelor's degree (in life sciences, RN, BSN degree preferable) or equivalent with a minimum of 5 years related experience in supporting medical device clinical trials. Implantable medical device experience a plus.
Experience with Electronic Case Report Form interfaces is desireable.
Excellent knowledge of GCRP CFR, GCP, local regulations and internal procedures required for clinical trials.
CCRA Credential or equivalent from a recognized Clinical Training Organization such as Association of Clinical Research Professionals is desirable.
Proficiency in Microsoft Office Suite
Strong verbal communication and scientific writing skills
Must exercise good judgment regarding routine and non-routine assignments; excellent time management, organizational and interpersonal skills.
Experience initiating Clinical Trials desirable
Travel within North America will be up to 75%. Will be working out of home office
Estimated Salary: $20 to $28 per hour based on qualifications.
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