Clinical Trial Associate

Clinical Trial Associate

The Clinical Trial Associate (CTA) will perform activities related to the planning, execution, and delivery of single and multi-site clinical trials in ProSciento's CRO division, under the direction of the Clinical Team Manager (CTM) and the Study Startup Manager (SSUM). The CTA will also function as a subject matter expert for the electronic Trial Master File (eTMF) and Clinical Trial Management (CTMS) system. This position will require an understanding of the basic skills necessary for the application of regulatory requirements, ICH/GCP guidelines, and CRO level methodologies. The CTA performs duties in accordance with company's values, policies, and procedures.

During Study Start-up:

• Manages the CDA execution process with sites and coordinate the Feasibility Questionnaire process
• Assists with the selection of investigators
• Provides study-specific details for the CTMS system set-up
• Delivers Regulatory Packet and trial-specific documentation
• Collects site essential documents for activation
• Compiles the package of documents for IEC/IRB and forwards to either the investigator or IEC/IRB as directed (throughout the entire study)
• Performs the first review of the Essential Document Packet and completes the SIV Authorization Form
• Populates and updates the Contact List in CTMS
• Prepares and ships Regulatory Binders to sites
• Coordinate initial shipment of lab kits, IP, and supplies to sites
• Ensures all documents for eTMF upload are in correct location, named and labeled appropriately upon site activation
• Participates in the SSU-to-Clinical Operations handover process

During Trial Maintenance:

• Responsible for collection of site-specific documents, including filing of documents in accordance with ProSciento's SOPs
• Performs central monitoring activities in collaboration with the site CRAs
• Reviews, maintains, and monitors lab kit supplies/inventory at the sites
• Tracks IP shipments and ensures adequate delivery timelines
• Contacts sites and vendors to facilitate the resolution of queries and data discrepancies
• Performs other Clinical or Site Management activities at the direction of the study CTM/PM

During Study Close-out:

• Ensures all site trial eTMF documentation is collected
• Performs the final site contact list reconciliation for trial
• Assists in the reconciliation of study supplies and document collection
• Assists in protocol deviation and vendor query reconciliation

Job Requirements / Qualifications/Education:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Familiarity with Good Clinical Practices (GCP), ICH guidelines and FDA regulations is preferred. The requirements listed below are representative of the knowledge, skill, and/or ability required:

• Bachelor's degree in health, biological science, or other related field and 1-year related experience in clinical research or other comparable combination of education, training, and experience. Technical skill in clinical software such as CTMS is preferred.

Knowledge, Skills, and Competencies Required:

Competencies:

• Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
• Learning on the Fly: Learns quickly when facing new problems; a relentless and versatile learner; open to change; analyzes both successes and failures for clues to improvement; experiments and will try anything to find solutions; enjoys the challenge of unfamiliar tasks; quickly grasps the essence and the underlying structure of anything.
• Planning: Accurately scopes out length and difficulty of tasks and projects; sets objectives and goals; breaks down work into the process steps; develops schedules and task/people assignments; anticipates and adjusts for problems and roadblocks; measures performance against goals; evaluates results.
• Dealing with Ambiguity – Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty.
• Priority Setting: Spends his/her time and the time of others on what's important; quickly zeros in on the critical few and puts the trivial many aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.

Skills, Knowledge, and Abilities:

• Basic knowledge and understanding of CRO clinical systems and procedures. Basic knowledge and understanding of applicable regulatory regulations. Working knowledge of clinical research; ICF review; IRB submissions; regulatory review/submissions; clinical site oversight; protocol review; and use of clinical systems.

Language Ability:

• Good communication skills, both verbal and written. Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

To perform this job successfully, an individual should have knowledge of MS Office software. Experience with clinical systems such as CTMS and eTMF preferred.

Conditions of Employment:

• Verification of educational requirements, employment history, professional references, and certifications/training and U.S. work authorization.

Working Conditions and Physical Effort:

Work Environment:

The work environment characteristics described here are representative of those encountered while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Work is normally performed in a typical interior/office work environment, remotely or in a hybrid arrangement based on approval from the department manager/supervisor.
• The noise level in the work environment is usually moderate.

Physical Demands:

The physical demands 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.

Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is frequently required to walk. The employee is occasionally required to stand.

The above job description does not imply these outlined duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.

ProSciento reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and company.

ProSciento is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.