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Lead/Sr. Clinical Research Associate

REMOTE, TX 78704

Posted: 01/17/2023 Employment Type: Contract To Hire Job Category: Clinical Development and Operations Job Number: 531346 Is job remote?: Yes Country: United States

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
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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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