1+ months

Senior Clinical Study Coordinator

Kelly Services
Rockville, MD 20851
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a direct hire opportunity to work as a **Senior Clinical Study Coordinator** located in **Rockville, MD** .

**Shift: Monday-Friday, 8am-5pm**

**20% Travel required**

**Job Description:**

A privately held, pre-IPO clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy using UNITE. Powered by LAMP (Lysosomal Associated Membrane Protein), ITIs UNITE platform is designed to utilize the bodys natural biochemistry to develop vaccines that have the potential to generate broad immune responses. The UNITE platform has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy, and autoimmune diseases. ITI is primarily focused on applying the UNITE platform in oncology, where it could potentially have broad applications, including antigen-derived antibodies as biologics. The company has built a pipeline of four wholly owned oncology programs, the lead of which is in a Phase 2 clinical study for Glioblastoma Multiforme (GBM).

The Incumbent will serve as a clinical representative for assigned projects. In association with his/her immediate supervisor, the Incumbent will manage the development and implementation process of the compan clinical operation services involving the Clinical Operations department or cross-functional teams focused on the delivery of new or existing projects. The Incumbent will proactively monitor projects from concept through completion. The Incumbent will organize and coordinate interdepartmental and outside vendor activities ensuring completion of the projects on schedule and within budget constraints to achieve success of the goals set forth at all stages in the clinical process. The incumbent will also ensure compliance with applicable company Standard Operating procedures and GCP guidelines, as well as Federal Regulations.

**Essential Functions**

Development of study timelines and budgets and obtain approvals from senior clinical leadership

Manage the progress of clinical studies in accordance with agreed upon timelines and budgets

Assure clinical study conduct is in compliance with SOPs,

Good Clinical Practice Guidelines and federal regulations governing the conduct of clinical studies

Identify issues affecting study conduct and work with department leads on satisfactory resolution

Develops requests for proposal (RFP) and coordinates the selection of CROs and outside vendors

Manages outside vendors and contractors

Tracks key project metrics and action items

Oversee the development, setup, and progress of all clinical study activities, including clinical management, Trial Master

File maintenance, regulatory compliance, site selection, enrollment, site monitoring, drug supply, adverse events/serious adverse events, data management, biostatistics, and medical writing

Oversee study activities by internal staff, vendors, and contractors

Oversee and manage the development of study protocols and all associated study documents

Track vendor and site payments

Develop and/or coordinate the development of documents in support of clinical studies (protocol, CRFs, ICFs, manuals, SAP, IB, etc.)

Work with internal departments and external vendors to establish appropriate study processes to ensure compliance with guidance documents and regulations.

Reports progress of clinical projects to clinical management

Participate in the development, review and approval of vendor agreements and budgets

Supports site management and monitoring efforts as needed

Monitoring of select sites to assure protocol & GCP compliance

The Incumbent will assist in preparing clinical documents for regulatory submissions

Mentor and train more junior level team members as needed

Participate in cross functional team meetings, representing the department and providing clinical updates

Assisting with financial planning and forecasting for assigned projects

Assisting with vendor identification and selection, including but not limited to Request for Proposal (RFP) development, Proposal review, working with potential vendors to refine assumptions for their proposals, compiling quotes for comparison of tasks/costs

Assisting with identification and/or development of needed SOPs, templates, systems

**Required Education and Experience**

RN or Bachelors degree within a health/biomedical sciences field, or related field and equivalent experience.

6+ years experience in working in clinical research and possessing 4+ years experience monitoring and/or management of clinical studies in the pharmaceutical industry or at a CRO. Experience managing study set-up and execution in multiple therapeutic areas preferred. Previous small to mid-size biotech experience preferred.

Knowledge of GCP, ICH guidelines and US FDA regulatory requirements for the conduct of clinical trials.

Proficient in basic computer programs such as MS Office Suite and MS Project.

Excellent written and verbal communication skills; ability to tactfully communicate sensitive information and demonstrated leadership capabilities

Ability to work independently and in a cross-functional team environment.

Must demonstrate excellent planning and organizational skills and an ability to generate creative solutions for complex problems.

Understanding of clinical development, regulatory and QA, CMC, clinical trials operations and project management methodology.

Understanding of basic protocol design and ability to implement/conduct phase I-IV clinical studies from start-up through closeout

Previous experience as a CRA or in data management helpful

Experience with budget and timeline management

Experience in drafting and review of monitoring plans, risk plans and other internal documents needed for study start-up and management

Experience in successfully participating in audits/inspections of assigned studies

Ability to travel at least 20% of the time if needed.

Ability to effectively manage internal and external teams

In depth understanding of the drug development process and how each step is connected

Prior experience in assisting in the development and deployment of clinical study supplies. This would include working with packaging and labeling vendors, collaborating on label text, etc.

Prior experience in assisting in the development and deployment of electronic case report forms. The incumbent would have a high-level understanding of how data management develops and deploys and eCRF system and what steps are necessary

Prior experience in working with and/or managing biostatisticians, data management personnel, medical writers to obtain needed data outputs, clinical study reports (CSRs), datasets and programs



**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.


Posted: 2022-07-18 Expires: 2022-10-10

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Senior Clinical Study Coordinator

Kelly Services
Rockville, MD 20851

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