Job Title: Clinical Research Scientist - III
Duration: Potential for conversion following 12 months depending on needs of the business
Location: Remote
Schedule is flexible but generally 9:00-17:00, can support EST or PST, remote
Description:
* Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols.
* Participates in protocol review discussions concerning scientific and procedural aspects of study design.
* Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision.
* With supervision, contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
* With supervision, addresses questions regarding scientific and related procedural issues from Investigators.
* With supervision, contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
* Assists in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs.
* Supports priorities within functional area. Anticipates moderately complex obstacles within a clinical study and with guidance implements solutions.
* May be asked to coordinate teams and provide direction.
* May lead two or more specific components of departmental strategic initiatives.
* Must be able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
* Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
* May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.
Requirements:
PharmD with 2+ years relevant scientific and/or drug development experience
MS with 6+ years' relevant scientific and/or drug development experience.
BS or RN with 8+ years' relevant scientific and/or drug development experience
Duration: Potential for conversion following 12 months depending on needs of the business
Location: Remote
Schedule is flexible but generally 9:00-17:00, can support EST or PST, remote
Description:
* Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols.
* Participates in protocol review discussions concerning scientific and procedural aspects of study design.
* Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision.
* With supervision, contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
* With supervision, addresses questions regarding scientific and related procedural issues from Investigators.
* With supervision, contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
* Assists in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs.
* Supports priorities within functional area. Anticipates moderately complex obstacles within a clinical study and with guidance implements solutions.
* May be asked to coordinate teams and provide direction.
* May lead two or more specific components of departmental strategic initiatives.
* Must be able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
* Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
* May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.
Requirements:
PharmD with 2+ years relevant scientific and/or drug development experience
MS with 6+ years' relevant scientific and/or drug development experience.
BS or RN with 8+ years' relevant scientific and/or drug development experience