- Develop and maintain expertise in the use of Clinical Research IO (CRIO) using available training tools and specialized instruction, particularly in source design.
- Understand the source data requirements of all assigned studies through reading protocols, attending relevant meetings, and coordinating with the medical, clinic, data, compliance, and finance teams.
- Perform Quality Control reviews on source documents created by other members of the Source Design Team, as assigned.
- Gather all required tools for the creation of source documents, including Electronic Data Capture (EDC) snapshots and guidelines, study protocol, study operations manuals, and other relevant documents that guide the collection of sponsor-required data points.
- Design initial source documents with lead oversight for all assigned studies prior to the Site Initiation Visit (SIV), to allow for clinical and financial review of source documents prior to their use.
- Attend all assigned SIVs and ensure that all questions affecting source documentation are adequately answered prior to the site being granted green light status.
- Maintain and update the tracking system to facilitate documentation of the creation and maintenance of all source documents, including dates, versions, and reviews by both clinical and financial parties.
- Update all assigned site source documents as required for all study protocol amendments prior to their next required use following the Institutional Review Board (IRB) approval of the amendment.
- Collaborate closely with the Source Manager to assist with the implementation of systems and procedures to continue to improve the source design process.
- Perform other duties as assigned or required.
- Strong knowledge of clinical research protocols and documentation requirements.
- Strong computer skills and an interest in learning to utilize new applications and functions.
- Exceptional critical thinking.
- Ability to determine and prioritize workload.
- Ability to handle multiple tasks/projects simultaneously.
- Exceptional communication skills, both verbal and written.
- Ability to collaborate with other team members to achieve results.
- Excellent organizational skills.
- Strong drive and personal initiative.
- Bachelor's degree required.
- At least 2 years of clinical research experience is required.
- Clinical Research Coordinating experience is preferred.
- Prolonged periods of sitting at a desk and working on a computer.
- Prolonged periods of standing, bending, and reaching.
-
Source Designer
2 weeks ago
Charter Research Orlando, United StatesCOMPANY DESCRIPTION · Charter Research is a highly experienced and quickly growing clinical research company, based in The Villages and Orlando, FL that is looking to add to our team to help us fulfill our mission of discovering future medicines. Our company is locally owned and ...
-
Exterior Designer
1 week ago
Martin Aquatic Orlando, United StatesMartin Aquatic is seeking an Exterior Designer, who is responsible for implementing creative outdoor plans for Martin Aquatic's waterpark, poolscape, and splashpad concept designs. Working as a part of the engineering firm's Creative Studio, this professional will assist the desi ...
-
Kitchen Customer Service Representative
2 weeks ago
LIOHER Enterprise Corp Orlando, United StatesThe **Kitchen Customer Service Representative** is responsible for **promoting and selling** the diverse range of products and services offered by the company to both existing and prospective clients. In this role, the representative will also demonstrate expertise in creating fu ...
-
Registered Nurse
6 days ago
Mederi Caretenders Orlando, United States Full timeWe are hiring for a Full Time RN to cover our Orlando patients · At Mederi Caretenders, a part of LHC Group, we embrace a culture of caring, belonging, and trust and enjoy the meaningful connections that come from it: for the whole patient, their families, each other, and the com ...
-
Bim Specialist
2 weeks ago
Conti Federal Services Orlando, United StatesConti Federal Services is a leading global construction and engineering company that has delivered some of the most demanding projects for the U.S. federal government. With roots dating back more than 115 years, Conti Federal specializes in military construction, critical infrast ...
-
Bim Drafter
2 weeks ago
Conti Federal Services Orlando, United StatesConti Federal Services is a leading global construction and engineering company that has delivered some of the most demanding projects for the U.S. federal government. With roots dating back more than 115 years, Conti Federal specializes in military construction, critical infrast ...
-
Narrow Aisle Sales Specialist
1 week ago
Ring Power Corporation Orlando, United StatesMain Duties & Responsibilities: · **Primary Job Role** · Develop specific direct account targets based on marketing supplied SIC Code list. · Assist in new machine deliveries and customer training after delivery is made. Conduct trade in inspections on an as needed basis. · Assis ...
-
Web Content Administrator
2 weeks ago
FIS Global Orlando, United States**Position Type**: · Full time · **Type Of Hire**: · Experienced (relevant combo of work and education) · **Education Desired**: · Bachelor of Communications · **Travel Percentage**: · 0% · Are you curious, motivated, and forward-thinking? At FIS you'll have the opportunity to wo ...
-
Capability Developer
2 weeks ago
US United States Army Futures Command Orlando, United States**Duties**: · - Serving as the Subject Matter Expert regarding the capability's development process for the Synthetic Training Environment Cross Functional Team. · - Advocating for the evolution of new or substantially new training equipment, augmented reality, artificial intelli ...
-
Proposal Manager
2 weeks ago
Soar Technology Orlando, United States**About Us** · At SoarTech, our focus is in the development of artificial intelligence (AI) that reasons like humans do, to automate complex tasks, simplify human-machine interactions, or model human behaviors. Our philosophy is three-fold: to be an augmentation to, not a replace ...
-
Surgical Scrub Tech
3 weeks ago
Orlando Ophthalmology Surgery Center (10626) Orlando, United StatesUSPI was founded in 1998 with a promise to deliver high-quality, lower-cost solutions in our communities, and in doing so, form collaborations with other like-minded institutions and physicians. Today we are the largest ambulatory surgery platform in the country, with more than 3 ...
-
Surgical Scrub Tech
3 weeks ago
United Surgical Partners International Inc (USPI) Orlando, United StatesUSPI was founded in 1998 with a promise to deliver high-quality, lower-cost solutions in our communities, and in doing so, form collaborations with other like-minded institutions and physicians. Today we are the largest ambulatory surgery platform in the country, with more than 3 ...
-
Distribution Manager
2 weeks ago
HII Orlando, United States**Date**:May 3, 2024 · **Location**: Orlando, FL, Florida, United States · **Company**:HII's Mission Technologies division · Requisition Number: 18887 · Required Travel: 0 - 10% · Employment Type: Full Time/Salaried/Exempt · Security Clearance: TS/SCI · Level of Experience: Senio ...
-
Analyst, Research- Consumer Insights
1 week ago
Universal Orlando Resort Orlando, United States**Universal Orlando Resort believes in-person collaboration is key to our success. Many of our Team Members work in a hybrid capacity, contributing from the workplace a minimum of three days per week. There are also roles that require being on-site full time. Limited remote oppor ...
-
Talent Acquisition Specialist
6 days ago
OneBlood Orlando, United StatesOverview: · Responsible for high volume recruiting and the strategic sourcing of talent that are aligned with the organization's business needs as it relates to staffing trends and best practices. This position plays a critical role in ensuring that the organization is recruiting ...
-
The Assistance Fund Orlando, United States**Summary of Position**: · The VP of Development and Strategy plays a key role at The Assistance Fund (?TAF?) in helping set and deliver the strategic objectives of the organization. Reporting to the Chief Development Officer and has primary responsibilities for designing and exe ...
-
Asst Men's Soccer Coach Ii
6 days ago
Seton Hall University South Orange, United StatesAsst Men's Soccer Coach II · **Job no**: 496294 · **Full time/Part time**: Full-time · **Location**: South Orange · **Categories**: Administrator · The assistant coach for soccer will assist the head coach in all aspects of the program that participates in NCAA Division I competi ...
-
Subcontract Manager, Staff
6 days ago
Lockheed Martin Corporation Orlando, United States**JOB ID**: 665897BR · **Date posted**: Apr. 29, 2024 · **Program**: Various · **Description**: · **WHAT WE'RE DOING** · Join Lockheed Martin Rotary and Mission Systems (RMS) where innovation and integrity drive our mission. We uphold the highest standards of business ethics and ...
-
Equipment Operations Manager
5 days ago
Hubbard Construction Company Orlando, United States100 Years of Experience at Work for You · Since 1920, the professional men and women of Hubbard Construction have literally paved the way for hundreds of public and private projects that have supported Florida's rise to prominence. · Hubbard is one of Florida's largest heavy civi ...
-
Fraud Prevention Analyst Ii
5 days ago
FIS Global Orlando, United States**Position Type**: · Full time · **Type Of Hire**: · Experienced (relevant combo of work and education) · **Education Desired**: · Bachelor's Degree · **Travel Percentage**: · 0% · Are you curious, motivated, and forward-thinking? At FIS you'll have the opportunity to work on som ...
Source Designer - Orlando, United States - CHARTER RESEARCH
Description
Job Description
Job DescriptionCOMPANY DESCRIPTIONCharter Research is a highly experienced and quickly growing clinical research company, based in The Villages and Orlando, FL that is looking to add to our team to help us fulfill our mission of discovering future medicines. Our company is locally owned and prides itself on providing exceptional patient experience to our participants, as well as offering agile recruitment strategies to our sponsors. Above all, we are a team, and we are seeking the right team member to add to our foundation in Orlando.
POSITION OVERVIEW
The Source Designer is responsible for creating and maintaining source document templates for the collection of all study protocol related data. The person in this role will collaborate closely with the source manager, medical, clinic, data, compliance, and finance team members to create source documents that gather the data elements required by the sponsor, provide adequate documentation to support the site's compliance with all relevant regulatory requirements, and ensure proper invoicing and payments related to work completed.
RESPONSIBILITIES
Education
PHYSICAL REQUIREMENTS