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Job Description
POSITION SUMMARY
The Project Associate (PA) will perform basic project management tasks in the planning, execution, and oversight of single and multi-site clinical trials in ProSciento s CRO division. The PA will also function as a subject matter expert for the electronic Trial Master File (eTMF) and Clinical Trial Management (CTMS) system. This position requires an understanding of the basic skills necessary for the application of regulatory requirements, ICH/GCP guidelines, contractual/budgetary guidelines, and CRO level methodologies. The PA performs duties in accordance with company s values, policies, and procedures.
DUTIES AND RESPONSIBILITIES
Performs the following study-level start-up activities, including but not limited to; Creates the study folder structure in SharePoint Assigns study-specific training to all applicable study team members Requests applicable study-specific system builds following established processes Creates the meeting invitations for; external Kickoff Meeting, Sponsor meetings, and vendor meetings if applicable Creates the agenda template for recurring sponsor meetings Drafts forms, logs, manuals, and plans that are Project Management related Finalizes study-specific plans, manuals, and forms; routes them for signature and submits them to Ensur for team member training as applicable Participates in vendor oversight and management (throughout the entire study) Distributes study documents to the vendors (Protocol, IB, etc ) Inform vendors of site activation dates (e.g., IP, PV, Labs) Prepares eTMF Plan and sets up the system Performs study-level maintenance activities, including but not limited to; Attends all internal, sponsor, and vendor meetings while documenting key decisions and actions Updates the agendas for sponsor and vendor meetings Updates calendar sponsor meeting invitations for appropriate team members as changes occur Reviews and updates contact lists for assigned studies as changes occur (within a few days of change occurring) and quarterly for study level personnel and vendors Initiates the annual review process for study plans and forms as applicable Maintains study-specific training submissions to Ensur and performs periodic reviews of the training tracker Responsible for the eTMF health check, including collection of trial-specific documents, filing of documents in accordance with ProSciento s SOPs Conducts QC of documents in the eTMF throughout the life of the clinical trial Updates the study milestones in Microsoft Project and CTMS, per the direction of the PM Maintains data entry in CTMS for applicable fields Assists PM with Investigator and Vendor invoice reviews and approvals Attends internal, sponsor, and vendor close-out meetings while documenting key decisions and actions. Reconciles final site invoices at the direction of the PM Completes a final contact list reconciliation for study-level personnel and vendors Performs the final eTMF Health Check Responsible for the final eTMF Preparation, QC, and delivery to Sponsor Coordinates the final system and documentation archival process
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 are a bonus. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education and Experience:
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
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.
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. 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.
