Remote Clinical Research Specialist Jobs

Assist with essential documents collection, review and archiving (TMF management)

Provide project management support for PTX project team, including vendor oversight

Conduct Site Initiation, Routine, and Close-out monitoring site visits, either on-site or remotely, prepare visit correspondence and records including trip reports

Oversee the conduct of assigned study sites, including ensuring compliance with SOPs, federal and local regulations, and ICH and GCP guidelines

Assist in the review and /or development of clinical trial documents such as study plans and training materials

Participate in and assist with facilitation of project team meetings

Clinical experience, perfusion, and organ procurement preferred.

Excellent communicator, delivering powerful presentations to diverse audiences, and building and maintaining relationships.

Travel to visit clients onsite for demonstrations, support, and training. Coordinate all travel logistics to ensure efficient and successful engagements.

Calling all Organ Procurement Coordinators and Specialists interested in moving into medical device!

Soft skills that create high-end customer service experiences with internal and external stakeholders.

Outstanding communication skill and achievement of search requests.

Working knowledge of grants and grant research techniques.

Ability to understand and interpret funding needs and requirements, including understanding budgets.

Able to manage time effectively.

Able to manage numerous tasks and clients simultaneously and effectively.

Experience with Clinical Trials Management System (i.e., OnCore, Velos, etc.)

Organize and manage time and tasks independently

2 years of health care operations experience preferably in clinical research

Demonstrated skills in critical thinking and problem solving

Strong written and verbal communication skills

2 years of clinical research experience

Effectively lead/manage low- to mid-level institutional or national projects that have tight timelines and limited visibility.

Act as a "go-to" resource for internal and external colleagues with less experience.

Exhibit excellent interpersonal and communication skills in collaborating with internal and external customers.

The responsibilities listed are a general overview of the position and additional duties may be assigned.

Lead programmatic efforts to locally produce videos, animated info graphics, and other educational materials.

Bachelor’s degree or equivalent experience (required)

3 years of previous clinical research field monitoring experience OR, quality assurance/control and regulatory compliance experience, required

Experience working in a medical device or regulated industry, preferred

Experience with electronic data capture, preferred

Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required

Demonstrated problem-solving and critical thinking skills

Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting

Organize the procurement and management of tools which will increase efficiency and scale research.

Collect and share research insights through the management of multiple research repositories.

Experience working with research CRM and recruiting platforms (e.g. Rally, User Interviews, Respondent, etc.)

In-depth experience scheduling sessions for multiple parallel studies and communicating with internal and external participants/stakeholders.

Knowledge of organizing and maintaining accessible research repositories (e.g. Dovetail, Coda, Confluence, etc.)

Excellent written and verbal communication skills.

Excellent customer service skills, knowledge of insurance providers and plans.

Completes any additional job duties as assigned.

High School Diploma or equivalent experience required.

1-2 years of experience in medical or related field required.

Knowledge of multi-modalities imaging reports.

Knowledge of medical terminology and knowledge of the reading and interpreting of radiology reports.

Five to eight years related experience required.

BA/BS – Bachelors Degree or equivalent required. MA/MS - Masters Degree or equivalent strongly preferred.

Proficiency in Microsoft Office Excel, Word, Access; Lotus Notes; Internet, PowerPoint, Visio and adaptability in learning new technology.

Follow established protocols and processes, with an eye towards improving operational processes to provide the best patient experience.

Be willing to take on additional clinical projects or responsibilities when necessary.

Demonstrated attention to detail and problem-solving skills.

Preferred, but not required: Knowledge of testosterone deficiency in men.

Own patient communications for clinical questions (e.g. side effects, prescriptions, labs) and know when to escalate the issue.

Work with the clinical and operations team to make sure the patient receives fast resolution to any concerns.

Skilled in calendar management and scheduling

Knowledge of internet marketing including email and forum management

Possess strong administrative and organizational skills

Ability to multitask and perform data entry and analysis

Experience in minutes and notes taking

Knowledge of telephone and conference calling

Develop and implement contract management policies and procedures

Manage contracts, global IP portfolio, and litigation matters

Register copyrights and manage annuity payments

Manage all aspects of legal holds and maintain reporting on litigation matters

Manage relationship with insurance providers about claims

Completion of paralegal school/certification highly desired

Strong organizational and time management ability.

Manage the study website, update content, and respond to queries from external investigators and NIH clients.

Prepare documents and power points, draft reports, and manage IRB submissions for multiple sites.

Minimum of 2 years of job experience in clinical/scientific research.

Excellent communication and collaboration skills.

Support research committees by organizing virtual and in-person meetings, preparing agendas, materials, meeting minutes, and action items.

Skills & Experience (top 3 skills):

•Quality Management System/Regulatory Compliance Program

Location:100% remote – EST support Henry Ford in Detroit (Remote)

Work Experience (do not edit):

•Regulatory certification from AAAHRP, SOCRA, PRIM&R or similar organizations

Insert major accountabilities in chart

Experience in site monitoring/central monitoring skills, site qualification, and site training

Data management experience or analytics

Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution

3 years of previous experience with regulatory documentation for clinical studies, required

Experience in cardiac clinical research

Sponsor industry experience with clinical trial operations/research

Serves as liaison between Physician Advisor/Medical Director, Finance, Case Management and CDCI

Identifies potential patient class mismatches based on planned OR Surgical CPT-4 assignment

Ensures that appropriate IP patient class is obtained for IP only Medicare cases prior to date of service

Conducts reviews of cases lost with feedback to respective departments

REMOTE Clinical Research Specialist ( Medical Device)- 6 months contract- May go perm

o Preferred, experience with electronic file system, Medidata and Sharepoint & Smartsheet.

5 + years, BA required. o Working as CRA (clinical research associate.)

o Familiar GDP (good documentation practices)

o Filling clinical trial documents ETMF