TechWerks is looking for a full-time Clinical Monitor to add to our growing team in Silver Spring.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Consultant shall perform clinical site monitoring as requested, to assess compliance with the
approved protocol, contractual agreement, and CFRs to ensure protocol and regulatory compliance.
Scope of clinical site monitoring will include, but not be limited to the following activities:
- Ensure compliance with local, state, and federal regulations, to include, but not limited to, local and institutional policies and procedures, FDA, ICH, NIH Guidelines, and HIPAA, as applicable.
- Drafting and finalizing study-specific clinical monitoring plans
- Site qualification visits
- Initiation visits prior to the start of enrollment
- Review of Essential Documents as part of the initiation visit
- Clinical monitoring of enrolled subjects.
- Drafting and provision of clinical monitoring reports
- Close-out visit
- Drafting and provision of study-specific closeout monitoring report
- Source verification of study data
- Monitoring performed according to good clinical practice (GCP) and TechWerks standard operating procedures.
- Site contact and follow-up for the assessment of subject recruitment, retention, and compliance. Utilization of clinical data management system (CDMS) to perform monitoring of eCRFs.
- Protocol development and clinical trials material development, as requested
- Training, as needed.
- These assumptions may vary based on Customer/Contract need.
1. BA or BS degree in Life Science/health related field required, Master’s degree is preferred
2. 5+ years’ experience as a Clinical Research Associate
3. Certified as a CRA, e.g. CCRA , CCRP, or other CRA certification required
4. Familiarity with monitoring processes in paper and/or eDC environments.
The above statements are intended to describe the general nature and level of work being
performed by individuals assigned to this position. They are not intended to be an exhaustive list of
all duties, responsibilities, and skills required. The employee must be able to work in a fast-paced
environment with demonstrated ability to juggle and prioritize multiple, competing tasks and
demands and to seek supervisory assistance as appropriate.
Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.