Senior Clinical Data Associate

Multiple Locations: St Petersburg, Russia • St. Petersburg, FL, USA

Notice

This position is no longer open.

Requisition Number: 1011

Position Title: Senior Clinical Data Associate

External Description:

WORLDWIDE CLINICAL TRIALS

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

SUMMARY: We are hiring a Senior Clinical Data Associate to join our growing team! Under the guidance and supervision of the Manager, Clinical Data Department, is responsible for overall database design, electronic case report form design, monitoring, management and processing and archival of clinical data.

Tasks may include but are not limited to:

Always represents Worldwide in a professional manner (verbal, written and in appearance) when interacting with Sponsors, volunteers, outside vendors and fellow employees.
Review study protocol and supporting documents for each study.
Regularly attend study initiation visits and study planning meeting.
Assists in the tracking of and drive departmental timelines and milestones.
Design study database to ensure accurate creation of eSource and case report forms for data collection.
Perform verification and User Acceptance Testing (UAT) of configured databases.
Create CRF and eCRF completion guidelines and access instructions.
Monitor data collection real time and post collection for quality and completeness.
Review, examine, and perform manual and automated quality checks of data to identify discrepancies and resolve data integrity issues.
Initialize the eSource/eCRF Trial Management System Checklist and edit check specifications.
Assist in creation of database reports.
Export clinical data listings and completed eCRF to vendors as required.
Assist and Perform database lock and or unlock procedures.
Provide support and training for staff using the database.
Manages archival of clinical trial documents (paper and electronic records) and complete requests for on-site and off-site archive.
Prepares documents for final study report inclusion and assists in corrective actions for findings.
Develops understanding of ICH-GCP Guidelines.
Responsible for requesting, scheduling and completing any training required for this position.
Identifies areas for process improvement and provides information to management.
Performs additional assignments as warranted by upcoming and ongoing clinical research studies.
Performs other duties as assigned.

The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

OTHER SKILLS AND ABILITIES:

Excellent written and oral communication skills.
Ability to understand complex written and oral instructions.
Computer systems and applications knowledge
Strong interpersonal skills.
Excellent attention to detail.
Exceptional organizational skills.
Ability to set and meet multiple deadlines
Knowledge of the clinical research process, including Good Clinical Practice

OTHER SKILLS AND ABILITIES (CONT.):

Possible equipment includes, but is not limited to: computers, rolling carts, fax machines, photocopiers, telephone, mop/broom, needles, scales, calculators, vital signs equipment, ECG equipment, and other medical equipment.

REQUIREMENTS:

Required: Bachelor’s degree with at least 3 years of clinical research or quality control experience.

Preferred: Bachelor’s degree (preferably in the field of Health); at least 3 years of clinic research experience and/or experience with Data Management, Regulatory documents and/or Quality Control/Quality Assurance in the clinical research field.

Other: Possible mental demands include, but are not limited to: reading, math, intense concentration, verbal communication, written communication, and client contact, exceptional attention to detail, multi- tasks, frequent interruptions, and fluctuation in work load.

Possible physical demands include, but are not limited to: Extended periods of time at a computer; lifting and carrying of objects weighing 5-50 pounds; hearing; seeing; gross and fine motor use of upper extremities; kneeling; walking; standing; leaning over for extended periods; squatting; eye strain/fatigue; climbing; pushing; pulling; reaching; exposure risk to potentially infectious blood and/or body fluids, and/or hazardous fumes or chemicals.

The Clinical Data Management Associate II will have contact with Sponsors and internal staff. Professionalism in behavior and appearance and customer service will be of the utmost importance as a representative of Worldwide. The Clinical Data Management Associate II must acquire and use exemplary skills in working with Worldwide staff regarding data and compliance issues.

The Clinical Data Management Associate II, is responsible for planning and managing his/her daily workload with the ultimate goal of meeting set study timelines. He/she must be self-motivated and able to manage multiple tasks and deadlines, to ensure that all deadlines are met. Must be able to coordinate with other clinical staff to communicate priorities and maintain an efficient workflow. Must be able to follow written and verbal communication.

#LI-MK1

City:

State: Sankt-Peterburg

Employment Type: Regular

Community / Marketing Title: Senior Clinical Data Associate

Company Profile:

Location_formattedLocationLong: St. Petersburg, RU

CountryEEOText_Description: