Quality Control Coordinator

Organization
HackEd
Job Location
Silver Spring, MD 20910
Salary
Competitive
Job Description

We are seeking a Quality Control Coordinator for WRAIR in Silver Spring, MD!Assist in all activities of the Lead Quality Coordinator (QC).

Assist in the review and development of clinical research protocols and Clinical Quality Management plans. (CQMP).

Implement and maintain a viable internal quality compliance function for all activities within the CTC (protocols and Lab area).

Develop internal monitoring plan appropriate for phase, complexity & size of trial.

Review and assure Regulatory Files are maintained and complete in accordance with applicable regulations and guidelines.

Maintain study records in accord with applicable regulations and guidelines.

Facilitate quality assurance monitoring by representatives of USAMMDA or other study sponsors.

Facilitate communication between CTC and other quality groups. Contribute to external audits and inspections when appropriate.

Review protocol specific source forms; subject, lab & IP prior to use.

Discuss deficiencies with staff & recommend modifications as needed.

Review documentation of ongoing studies for accuracy & completeness, documenting deficiencies constructively as queries for the CRC and Investigator, providing references as appropriate to improve study implementation practices; with follow through reviewing responses to ensure they are complete and appropriate.

Manage Department SOPs: Maintain official & archived documents, table of contents, conduct/oversee biannual review process, write & format SOPs in collaboration with other team members, following institution policy.

Recommend appropriate staff training to the SCRC.

Maintain and update on-site archive tracking document for all studies conducted at the CTC.

Coordinate transfer with the WRAIR Archivist (or Sponsor) to off-site location.

Participate in other aspects of conducting clinical trials within CTC as required Provide technical assistance to CRM Headquarters as needed and participate on proposal writing projects when requested.

Provide all job-related progress reports/technical reports as requested.

Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations.

Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.

Performs light duties and other related duties as required and assigned.

 

 

Requirements

Qualifications:

Clinical research experience with at least 3 years and/or CCRC/CCRA certification.

Required Knowledge, Skills and Abilities:

Knowledge of applicable highly complex office procedures and techniques relating to position.

Physical Capabilities: work may involve long periods of standing.

Work Environment: Clinical environment; may require working evenings and weekends.

Must be able to work independently following a brief period of specific technical training.

Working Conditions/Physical Demands: Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment: 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. General Information: 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. T

he 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.

ClinicalRM is an Affirmative Action-Equal Opportunity Employer www.clinicalrm.com "NorthCoast 99" Best Places to Work recipient

How to Apply

Email your resume to the Recruiter below [email protected]

PLEASE INCLUDE YOUR NAME AND THE POSITION TITLE

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