Looking for subject matter experts / consultants in clinical research, clinical trial, risk management, audit and inspection, gcp, clinical outsourcing, trial design and management,ethics fraud and misconduct, patient recruitment , documentation and management, clinical laboratories, facility/hospital , hospital clinical compliance, billing and coding for clinical services , patient/third-party coding and billing, sponsors, cros, clinical quality control/cqc for speaking engagements with over 25+ years of experience. Feel free to reach out to me.+20 Other Responses
Outsourcing Clinical Research
Looking for subject matter experts / consultants in clinical research, clinical trial, risk management, audit and inspection, gcp .Feel free to reach out to me.+46 Other Responses
Clinical Research Coordinator
Job title: clinical research coordinator
job location: phoenix, az
job type: full time
**education, certification/licensure, and/or experience**:
- position requires a certified tumor registrar (ctr) or a certified clinical research coordinator with 3-5 years of experience in data collection activities within a gcp/clinical research regulatory environment.
- clinical study experience in oncology
- prior experience in a healthcare or laboratory environment strongly desired.
- strong medical terminology understanding.
- experience in both small and large scale project planning and reporting with strong communication and presentation skills.
- experience in providing training for both internal and external staff with a mentorship approach for less experienced team members.
- a high degree of human relation skills are required to interact across multiple facilities at various levels.
- knowledgeable about the critical elements for success in clinical trials. Gcps, federal regulations and clinical trial process. Strong and demonstrable communication, collaborative, and analytical skills are required.
- a demonstrated ability to communicate effectively at all levels.
- strong experience with edc systems and ivrs.
- proposes, implements, and evaluates appropriate resolution.
- the clinical research coordinator (crc) is responsible for clinical data management activities for the caris medical affairs protocols and projects.
- primary responsibilities include clinical data review and query initiating thru resolution.
- responsibilities involve management of all clinical investigative sites according to the federal code of regulations, good clinical practices, ich guidelines, local regulations, and clinipace sops and/or sponsor sops, support of enrollment of new client sites, orientation and training of clinical data procurement and all associated project sponsor tasks as related to clinical data management.
- maintain ongoing clinical research site correspondence and site files.
- clinical research coordination certification, clinical research professional certification, and/or certified tumor registrar experience is preferred to follow quality assessment methodologies associated with data collection, while adhering to national data standards and requirements.
- provides support to external research coordinators in their function of patient enrollment, data collection, and data query activities.
- coordinates project activities to ensure data compliance and timely collection of data endpoints to achieve project milestones.
- adheres to sop’s, good clinical practice (gcp), and good registry practice (grp).
This job does not provide visa sponsorship.+13 Other Responses
Oncology Clinical Research Associate
The clinical research associate completes project activities associated with monitoring functions of phase i-iv clinical research studies. Perform investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (sops).
-knowledge of applicable sops, guidelines and study procedures.
-assist with protocol and crf review.
-develop informed consent forms.
-conduct study feasibility and site selection activities.
-assist with the development of study manuals, annotated crfs, monitoring conventions, tracking forms, site study tools, and other study materials.
-develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities.
-assist with investigator meeting activities including organization, preparation and attendance.
-conduct site management activities, including but not limited to site qualification visits, site initiation visits, site training, site interim monitoring visits, and site close out visits.
-perform co-monitoring visits and performance assessment visits, when properly trained and delegated by clinical research manager
-ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.
-establish and maintain good rapport with study sites.
-write study visit reports and follow up letters within the timeline established by applicable sops and guidelines
-coordinate timely shipment of clinical supplies and study drug to sites.
-ensure proper storage, dispensation and accountability of clinical supplies and study drug.
-maintain adequate site tracking records.
-follow up of drug safety issues and safety reports in timely manner, if applicable.
-communicate site study issues, concerns, and progress to clinical research manager, project manager and clinical team lead accordingly.
-assist with data query form (incl. Query process).
-perform telephone monitoring activities in order to obtain study status information.
-development and implementation of corrective actions when appropriate.
-prepare/review all patient tracking records.
-input and maintain study information concerning subject status of financial reimbursement to sites.
-mentor for site manager and/or site manager ii, when assigned
-conduct on the job training and formal training to other site managers.
-collaborate with clinical research manager/ study teams to resolve site issues
-review study visit reports, follow-up letters and site communication generated by other site managers for timeliness, quality, consistency, and appropriate documentation and resolution of issues, with support from clinical team lead or clinical research manager as needed.
-bachelor’s degree, preferably in allied health fields: medical, nursing, pharmacy, psychology, veterinary or health science.
-minimum of 4 years of clinical research experience; preferably in clinical research monitoring of international, multi-center clinical trials in multiple therapeutic areas.+19 Other Responses
Clinical Research Organization
we are a prominent nyc-based expert network and an authorized zintro partner
our client has an immediate need to conduct phone consults with multiple experts knowledgeable about contract / clinical research organization (cro) industry. More specifically, they are hoping to better understand the overall market growth, trends & outlook, as well as key segments.
Here's more information on the type of people they are looking to speak with:
• a cross-section of pharma and biotech players of different sizes
o expert must have ownership of development pipeline
o have expertise related to key large/growing tas (therapeutic areas) and regions – initial hypothesis is focused on oncology, infectious diseases/vaccines, immunology
o we would probably like to speak to mostly us players, some european and a couple in asia
• sponsor members who own (or influence) outsourcing decisions (e.G., operations, clinical research)
• cro members responsible for strategy/planning and pricing decisions
• potentially across other segments of the value chain
tj+19 Other Responses
Business Development For Contract/clinical Research Organisation
Looking for an expert to help in business development strategies and tactics for a niche cro (contract/clinical research organisation), specifically as it relates to exploiting scientific expertise and connecting to scientific decision makers in pharma and biotech+18 Other Responses
Clinical Research Regulations
Looking for an expert in clinical research and regulatory issues, with preference in latin america.+5 Other Responses
Clinical Research Associate
This is a full time employment opportunity in the northeast, usa.
responsible for management of clinical trial sites ensuring compliance with regulations, protocol(s), and overall clinical objectives. Analyzes clinical data. Maintains a high level of professional expertise through familiarity with clinical literature.
Position can be located in pa
conduct site pre-study, initiation, routine monitoring, and study closeout visits.
Monitor, track, and manage all study related tasks at study sites ensuring compliance with gcp, ich, applicable regulations and company sops.
Collect, review, track, and ensure appropriate completion of site-specific study/essential documents. Performs ongoing reconciliation of the trial master file (tmf) content to site files.
Primary contact for study site personnel.
Provide training to site personnel.
Track and report progress of study sites.
Responsible for quality data from study sites. Ensures appropriate source documentation, training, and accurate transcription of data into the study case report form (crf) as evidenced by minimal data query rates. Ensures timely reconciliation of data queries and implementation of process improvement/corrective action when needed.
Participate in team meetings.
May take meeting minutes, develop and maintain study trackers, or assume other tasks to support study team.
Coordinate, assemble, and ship study related supplies as needed.
Assist with creation and review of study tools/documents.
Maintains awareness of overall development in the field of clinical research based on current literature, attendance at professional meetings, continuing education, etc.
Skills, education and experience:
requires a bachelor’s degree (ba, bs or bsn) from a four-year college or university in a scientific discipline or equivalent combination of education and work experience plus minimum of two years pharmaceutical clinical research experience.
Knowledge of gcp/fda/ich regulations required.
Have a broad understanding of clinical research. Have a working knowledge of the relevant sops.
must be able to travel with overnight stays both domestic and internationally. Must have the quality-service attitude and be willing to work additional hours to meet deadlines.
Position location and/or territory and travel
position can be located in pa , ny, nj
required to make site visits.
Position may require approximately 50-75% travel with some overnight travel.+30 Other Responses
Clinical Research Regulatory Service
• study objective:
to assess the clinical research consulting space with special emphasis on independent review board (irb) services. The aim is to understand the dynamics in the service/product offerings (regulatory compliance, medical writing, strategic affairs, electronic consent manager, meeting scheduler etc.). In addition, we would also like to understand the market overview of irb services comprising of market size, recent trends, drivers, barriers, etc. Focus would be to understand the customer needs, competitive landscape, pricing and market landscape for irb consulting services (regulatory compliance, medical writing, strategic affairs etc.).
• following are some of the key questions:
o what are the different services offered under regulatory consulting in clinical research?
O who are the key users / customers of regulatory consulting services?
O what are the needs for these services of different customers
o what are the factors that influence the customer’s purchase decision of consulting services / products?
O who are the top players providing consulting services and what is their market share?
O what are the billable rates charged on an hourly basis by the companies?
O why, if at all, do the rates differ across various services?
O are there different rates for different customer types? What are the reasons?
O how is the pricing structured for software products such as electronic consent form, meeting scheduler etc.?
o what are the key market trends, growth drivers and barriers to growth etc.?
o where are the key opportunities within the regulatory consulting market?
Preferred expert should meet the following criteria:
o location: us
o industry experience of 15+ years in the clinical research industry
o worked in coordinating clinical trials, device trails and observational studies, regulatory & irb submission, recruitment, data collection and input, source documentation creation, and overseeing good clinical practices (gcp) and ich guidelines
o understanding of clinical studies to ensure compliance with ich/gcp guidelines and federal regulations
o knowledge of regulatory consulting services as well as software offerings specific to clinical trial / research
o understanding of purchase process and pricing structure of consulting services+12 Other Responses
Clinical Research Coordination
We are seeking a clinical research coordinator for a full time career opportunity in arizona, usa.
-must have clinical study experience in oncology.
-position requires a certified tumor registrar (ctr) or a certified clinical research coordinator with 3-5 years of experience in data collection activities within a gcp/clinical research regulatory environment.
The clinical research coordinator (crc) is responsible for clinical data management activities for protocols and projects. Primary responsibilities include clinical data review and query initiating thru resolution. Responsibilities involve management of all clinical investigative sites according to the federal code of regulations, good clinical practices, ich guidelines, local regulations, and clinipace sops and/or sponsor sops, support of enrollment of new client sites, orientation and training of clinical data procurement and all associated project sponsor tasks as related to clinical data management. Maintain ongoing clinical research site correspondence and site files.+16 Other Responses
Clinical Research Organization (cro)
**please respond to the following request with a proposal if:
1) you currently, or within the last year, work at a pharmaceutical or biotech firm.
2) you are familiar with phase 1 clinical trials.
Familiarity with and understanding of how biopharma and pharmaceutical companies decide which cros to use for early stage phase 1 clinical research. Will be able to speak to growth trends related to spending on r&d in industry and spending on cro services. To the extent possible, will be able to speak to how this may differ for innovator versus generic drugs. Will be able to speak to the reputations of different cro service providers for early stage phase 1.
1) how has your spending on cro early stage services trended in the past few years? What is your outlook for demand for cro services? Why? To the extent you can speak to this, how has this differed for generic vs. Innovator drugs?
2) what is the decision process for determining which early stage phase 1 cro to use?
3) what factors are considered when determining which early stage phase 1 cro to use?
4) what are the early stage phase 1 cros that come to mind? Which cros have you considered? How do cro reputations differ across the different stages of clinical research (early vs. Late)? For different clinical services?
5) what are the trends for early stage phase 1 cro services moving overseas?
Areas of expertise:
seeking experts with knowledge of clinical trials, phase 1-4; clinical trials; early clinical research; cro; early stage clinical research; cros; clinical research organization; clinical research+7 Other Responses
Consumer Healthcare And Clinical Research
I am looking for an expert on consumer healthcare r&d clinical spend.
Please note best practices need to be from consumer healthcare industry only and not from pharmaceutical or any other industry
how do fmcg/consumer healthcare companies manage this category?
Does msp (managed service provider - msp) model exist in this industry?
What size and number of cros are being used by fmcg/consumer health companies?
Are there any global cros able to support niche areas such as skin, nutrition and oral health?+14 Other Responses