Clinical Trials Contracts Specialist Jobs

Possess a minimum of 7 years of clinical trial management experience, with a focus on recent Oncology trials.

Train team members and partners, maintain study files, provide regular updates to management, and ensure compliance with GCP.

Lead study teams, foster relationships with external partners (CROs, labs, IRBs, sites), and identify/manage risks.

Assist in site selection, create RFPs, negotiate contracts, manage budgets, and oversee invoicing.

Show experience in international trials and managing external providers, including CROs.

Efficiently oversee clinical trials, managing multiple studies within a development program.

Degree level qualification or equivalent experience plus a minimum of one years’ experience in a related role

Arrange and track system access for project team (Project Managers, Lead CRAs, CRAs, etc.)

Strong organizational and problem-solving skills

Excellent skills in MS Office applications including Outlook, Word, Excel and PowerPoint

Skill sets and proven performance equivalent to the

Maintain and quality audit to assure the most recent revisions of documents are on project portals

Minimum 3 years of document management experience.

5+ years of document management experience

Experience working with clinical electronic databases, preferably Medidata Rave

Experience in organizing documents for internal and external audits

Facilitate the design and development of data collection forms, instructions and procedures.

Develop and maintain flow diagrams developed to document coding processes around eligibility and randomization.

At least 5 years of clinical trial management experience; Recent Oncology trial

Effective trial management of a clinical study or multiple studies within a clinical

Management of the study team for assigned studies or programs and of relationships with

Provide management with routine updates regarding the status of ongoing studies

Understanding of cross-functional areas including data management / biostatistics,

Brochures, Study Manuals, Statistical Analysis Plans, CRFs, Data Management Plans, and

Experience with the following computer applications: OnCore, EPIC, Advarra EDC, other clinical trial management systems and electronic data capture system.

Assist PI and CTO Project Managers in incorporating multi-site requirements/aspects into a developing protocol.

Supporting CTO Project Managers With Study Study Monitoring and Management:

Manage SAE/DLT information. Prepare and submit reports to the FDA, drug manufacturer and/ or participating sites, as applicable.

2-4 years of experience as a Clinical Research Coordinator (CRC), Clinical Research Associate (CRA) and/or Research Project Associate.

Working knowledge of state and federal guidelines as they apply to the conduct of clinical research.

Assist PI and CTO Project Managers in incorporating multi-site requirements/aspects into a developing protocol.

Supporting CTO Project Managers With Study Study Monitoring and Management:

Manage SAE/DLT information. Prepare and submit reports to the FDA, drug manufacturer and/ or participating sites, as applicable.

2-4 years of experience as a Clinical Research Coordinator (CRC), Clinical Research Associate (CRA) and/or Research Project Associate.

Working knowledge of state and federal guidelines as they apply to the conduct of clinical research.

Knowledge of GCPs governing clinical research.

Desired Experience, Skills and Abilities:

Enter country level information in BI Clinical Trial Management System (CTMS) and related systems.

Under the direction of the CTL/CTM or Feasibility Manager (depending on the task/activity), the CTO will:

Create trial specific slide decks, training material, etc. in accordance with BI requirements.

Excellent communication skills (written and oral)

In addition to the CTO responsibilities and duties, they may provide assistance in leading the trial team:

Bachelor’s degree in Life Sciences or related field and at least 2 years of clinical research and project management experience

Knowledge of clinical trials, and experience applying applicable clinical research regulatory requirements (i.e. GCP and ICH guidelines)

Knowledge of project finances including experience managing, contractual obligations and implications

Knowledge of EDC systems and technology enabled solutions (EMR/Health Record Experience, Hybrid trials) with respect to use in clinical trials.

Identify changes in scope and manage the change control process, as necessary

Experience collaborating with others to deliver results to meet timeline, metrics and budget.

Operations Management: 2 years (Required)

The successful applicant will have access to all Re:Cognition Health’s benefits.

Chicago, IL 60611: Reliably commute or planning to relocate before starting work (Required)

Clinical Trials Coordinating: 3 years (Required)

Clinical research: 4 years (Required)

The post holder is responsible for:

Perform monitoring of the Clinical Contract Management “CCM” mailbox..

Ensure all fully executed clinical contracts are uploaded onto Seagen Contract Lifecycle Management (“CLM”) system on behalf of Shared Services

Complete training assigned including general training requirements, SOPs, and system and process related training.

Provide list of effective Master Non-Disclosure Agreements and Master Clinical Trial Agreements (MNDA/MCTA) for site on new studies to key stakeholders.

Perform Known Clinical Site (“KCS”) verification and re-verification.

Submit contract request in Seagen systems when support is needed.

Needs to be communicative and responsive and know when to escalate and communicate issues to management.

Oncology clinical research experience is required.

Any experience working with solid tumors is a big plus.

Demonstrated computer skills with Microsoft Office applications.

Vitalief is offering a $3,500 sign-on bonus for this position!

You'll impact clinical research in various therapeutic areas, including oncology, and improve outcomes for diverse populations.

Manage and effectively communicate Firm’s travel needs to vendors/resources.

Work on developing internal processes to enhance travel experience for attorneys and staff.

A minimum of 5 years of experience in travel or hotel sales and a Bachelor’s Degree.

Establishment and promotion of strong working relationships with external contacts and suppliers to ensure the Firm’s needs are understood and met.

Creation and dissemination of travel resource communication to the Firm.

Develop relationships with paralegals to assist with their trial related travel needs including contracting hotel guest room and meeting space.

Knowledge, Skills And Abilities (required)

Experience with Electronic Data Capture (EDC)

Some knowledge of medical terminology

Strong clerical, interpersonal, and organizational skills.

Ability to exercise judgment and employ basic reasoning skills.

Extraction and entry of required clinical data from medical records and patient research charts/reports to Clinical Research Forms (eCRFs/CRFs).

Evaluates patients’ progress toward attaining expected outcomes. Demonstrates the ability to reflect knowledge of current professional practice standards, laws and regulations.

All other duties as assigned within the scope and range of job responsibilities

Education Master Degree Master Degree Master Degree Science Health Care Related field

Credential Certified Clinical Research Associate

Ensure client satisfaction through continued relationship management

1+ years of experience in the clinical research industry, or similar 

Salesforce experience is a plus

Experience with clinical trials is a plus

A self-starter and a hunter’s mentality 

Bachelor's of Science, is a plus 

Stay abreast of project management certification standards and industry principles through professional associations and implements practices. 4

Creates project in designated project management software and ensure all necessary staff have access.

Recommend and support routine project management meetings, updates and prepare a variety of status reports and dashboards.

Assist staff coordinate project management activities, to include routine meetings and development of reports.

Conducts project analysis and reports to upper management.

Develop summaries of project status and performance for review with upper management.

Experience in clinical trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB.

Knowledge, Skills And Abilities (required)

Bachelor’s degree and three years of related experience or a combination of education and relevant experience.

Manage and oversee new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support.

Excellent communication skills and superb attention to detail.

Experience with MS Office products and database applications required.

·5 years’ Experience of Study Management within a pharmaceutical or clinical background

·Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management

o Manager would like to see candidates with Clinical Research experience.

·This position necessitates providing leadership, direction, and guidance through process improvement, interactive communication and stakeholder management.

Job Title:Pricing and Contract Strategy Manager (Clinical Contracts)

o Looking for someone that has experience that has negotiating contact language and budgets with clinical contracts.

5 years of specific RFI, RFP, Contracting and/or Budget management experience

Other duties as assigned by management.

Clinical Contracts Manager - REMOTE

Works with Supplier Relationship Manager and Legal to establish Master Services Agreement (MSA) for as many suppliers as possible.

Works with Supplier Relationship Manager to incorporate Key Performance Indicators into contracts for applicable suppliers.

Bachelor's Degree in Business / Finance or industry related field

Assist in the collection and management of clinical data and collection of source documents

Review CPRS (Computerized Patient Record System) patient charts to screen for possible subjects and to compile data

Perform tasks to ensure smooth clinic flow including organization of supplies, preparation of paperwork, and communication with study and clinical staff

Recruit and consent research participants for various clinical trials and research projects

Trouble-shoot and modify protocol implementation when necessary

Obtain various measurements from participants including vital signs and waist and hip circumference