The Planet Group
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http://www.theplanetgroup.com
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Lead/Sr. Clinical Research Associate
REMOTE REMOTE, TX 78704 US
Posted: 01/17/2023
2023-01-17
2023-02-25
Employment Type:
Contract To Hire
Job Number: 531346-1
Country: United States
Is job remote?: Yes
Job Description
Primary Roles and Responsibilities
Describe the essential and frequent duties and responsibilities of the role • Conducting selection, initiation, activation, monitoring, and close out of clinical study sites (both on-site and remotely), and/or co-monitoring for internal or outsourced monitoring visits
• Performing oversight visits for CRO CRAs and/or assessment visits for internal CRAs
• Mentoring/managing other CRAs or Clinical Trial Assistants
• Reviewing and approving monitoring visit reports
• Managing internal/external study metric indicators (eg, CRF completion and query resolution, site issues, protocol deviations, Serious Adverse Events, etc)
• Assisting with data cleanup for database locks and other time-sensitive deadlines; conducting remote data reviews and query resolutions to assist clinical project managers and internal data management
• Assisting with supply management, communications, newsletters, and other site-related tasks
• Assisting with and/or leading the development, drafting, review and/or revision of protocols, ICFs, study plans (e.g., Monitoring Plan, Study Operations Manual, Laboratory Manual, Pharmacy Manual, etc.), CRFs, Clinical Study Reports, monitoring tools or other study/site documents
• Assisting in the hiring, training, and mentoring of other CRAs
• Ensuring company SOPs, FDA regulations, ICH guidelines, and protocols are being adhered to by self, other CRAs, investigational sites, etc
• Assisting with planning and participating in investigator meetings
• Other duties as assigned/requested
• Ability and willingness to travel: o Standardly, up to 70% of the time (mostly domestic but some potential international travel may be required),
o Occasionally, during crunch times/important deadlines, up to 90%
Skill Requirements
List certain skills required to qualify for the role such as technical and soft skills (communication, Microsoft suite skills, use of specific tools or software systems, decision-making, strategic, analytical, et.) • Demonstrated ability to work independently and in a team environment
• Strong attention to detail and organizational abilities
• Excellent oral and written communication skills
• Proficiency with MS Office
Qualifications Requirements
List requirements candidate need to qualify and be successful in this role (specific degree, license, years of experience, etc.) • BA/BS in science field, nursing/medical degree (associate of applied science or above), or similar; advanced degree is a plus
• Seven plus years of CRA or other relevant experience o Two plus years in a pharmaceutical/biotech company strongly preferred ? Small pharmaceutical/biotech experience is a plus o Two plus years of experience with a CRO strongly preferred • Certification (e.g. CCRA, CCRP, etc.) strongly preferred
• Demonstrated in depth knowledge of GCP, ICH guidelines, and FDA regulations
Describe the essential and frequent duties and responsibilities of the role • Conducting selection, initiation, activation, monitoring, and close out of clinical study sites (both on-site and remotely), and/or co-monitoring for internal or outsourced monitoring visits
• Performing oversight visits for CRO CRAs and/or assessment visits for internal CRAs
• Mentoring/managing other CRAs or Clinical Trial Assistants
• Reviewing and approving monitoring visit reports
• Managing internal/external study metric indicators (eg, CRF completion and query resolution, site issues, protocol deviations, Serious Adverse Events, etc)
• Assisting with data cleanup for database locks and other time-sensitive deadlines; conducting remote data reviews and query resolutions to assist clinical project managers and internal data management
• Assisting with supply management, communications, newsletters, and other site-related tasks
• Assisting with and/or leading the development, drafting, review and/or revision of protocols, ICFs, study plans (e.g., Monitoring Plan, Study Operations Manual, Laboratory Manual, Pharmacy Manual, etc.), CRFs, Clinical Study Reports, monitoring tools or other study/site documents
• Assisting in the hiring, training, and mentoring of other CRAs
• Ensuring company SOPs, FDA regulations, ICH guidelines, and protocols are being adhered to by self, other CRAs, investigational sites, etc
• Assisting with planning and participating in investigator meetings
• Other duties as assigned/requested
• Ability and willingness to travel: o Standardly, up to 70% of the time (mostly domestic but some potential international travel may be required),
o Occasionally, during crunch times/important deadlines, up to 90%
Skill Requirements
List certain skills required to qualify for the role such as technical and soft skills (communication, Microsoft suite skills, use of specific tools or software systems, decision-making, strategic, analytical, et.) • Demonstrated ability to work independently and in a team environment
• Strong attention to detail and organizational abilities
• Excellent oral and written communication skills
• Proficiency with MS Office
Qualifications Requirements
List requirements candidate need to qualify and be successful in this role (specific degree, license, years of experience, etc.) • BA/BS in science field, nursing/medical degree (associate of applied science or above), or similar; advanced degree is a plus
• Seven plus years of CRA or other relevant experience o Two plus years in a pharmaceutical/biotech company strongly preferred ? Small pharmaceutical/biotech experience is a plus o Two plus years of experience with a CRO strongly preferred • Certification (e.g. CCRA, CCRP, etc.) strongly preferred
• Demonstrated in depth knowledge of GCP, ICH guidelines, and FDA regulations