Job Description
Job Title: Contract Senior Clinical Research Associate
Department: Monitoring
Location: Maryland
PURPOSE
The Contract Senior Clinical Research Associate (CRA) conducts site monitoring responsibilities for clinical trials, according to Standard Operating Procedures (SOPs), FDA regulations, ICH guidelines, and Good Clinical Practices (GCP).
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
Other duties may be assigned. Contractor performs all, part, and/or any combination of the duties listed below.
- Independently manages and monitors site activities for assigned clinical studies, working individually or co-monitoring with other CRAs.
- Monitoring activities will include but not be limited to site qualification, site initiation, interim monitoring, and close-out visits. These visits will be completed independently.
- During monitoring visits, the CRA ensures compliance with the protocol and applicable Lotus or Sponsor SOPs, FDA regulations, and ICH-GCP guidelines.
- Independently and proficiently performs site evaluation visits of potential investigators. Thoroughly evaluates the site’s capability to successfully manage and conduct the clinical study.
- Expertly and independently performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the case report forms, monitoring activities and study close-out activities.
- Ensures the Investigator Site File is kept audit-ready and ensures documents are collected and uploaded into the Trial Master File on a regular and timely basis.
- Has direct communication with investigational sites on visit planning, query resolution, action item resolution, and any other activities to support site management.
- Independently documents accountability, stability and storage conditions of clinical trial materials as required by the Monitoring Plan. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
- Serves as primary contact with the site; coordinates all correspondence; ensures timely transmission of clinical data with the study site.
- Expertly and independently performs study close-out visits per the study specific Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
- Ensures internal and study-related trainings are completed per Lotus and/or study timelines.
- Pre and post visit follow up include compliance to timelines indicated in the Monitoring Plan for Confirmation Letters, Follow up Letters and Monitoring Visit Reports.
- Performs other related duties as requested.
SUPERVISORY RESPONSIBILITIES
Position does not require direct supervision over other team members; however, position may require collaboration with the CRA Line Manager to support the mentoring, training, and assessment of CRAs and junior staff as applicable.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Ability and willingness to travel up to 100% of the time (land and air), both domestically. The requirements listed below are representative of the knowledge, skill, and/or ability required.
EDUCATION and/or EXPERIENCE
Bachelor's degree or equivalent experience in life science/healthcare is required accompanied by at least 5 years of field experience working within clinical research as a CRA.
Mastery of the CRA II Job Responsibilities.
Valid Driver’s License.
Legally authorized to work in the US as an independent contractor (LLC or INC.) or through an agency.
SKILLS and/or ABILITIES
Expert knowledge of the drug development process, ICH guidelines, GCP, and the clinical trial process.
Proficiency in using electronic CRF platforms and processes.
Excellent interpersonal skills.
Exceptional attention to detail.
Ability to interact effectively within and across team environments.
Excellent organizational skills.
Exceptional ability to exercise professional judgment and uphold ICH GCP guidelines and determine appropriate action to a variety of problems of varying complexity.
Strong ability to work effectively and efficiently handling multiple tasks simultaneously.
Consistent ability to manage and meet multiple deadlines.
Ability to work independently.
Proficient computer skills with good working knowledge of a range of standard computer software required (e.g., email, document, spreadsheet, and presentation software). Ability to submit invoices, expense reports, etc. in a timely manner in accordance with Lotus’s Finance Department requirements.
Contractor shall be responsible for their own insurance.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by a contractor to successfully perform the essential functions of this job.
While performing the duties of this job, the Contractor regularly reaches with hands and arms. The contractor periodically is required to lift and/or carry up to 10 pounds. Occasionally, contractor stoops, bends, kneels, and crouches; and pushes/pulls filled wheeled carts. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those a contractor encounters while performing the essential functions of this job.
May work in a clinical research site environment where the noise level is usually moderate, a travel environment where the noise level is usually moderate to high, or in home office environment where the noise level is largely controlled by the contractor. Contractor may be subject to many interruptions; pressure due to meet deadline requirements; and handling multiple tasks simultaneously while performing assigned duties.
SAFETY REQUIREMENTS
Contractor is required to pay particular attention to safety practices when traveling and/or visiting a clinical research site including following all safety, environmental, and infection control guidelines, procedures and protocols including wearing appropriate safety/protective equipment. In the interest of safety, Lotus Clinical Research contractors should practice safe use of cell phones and other mobile devices while driving on Company business and/or Company time.
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