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Clinical Research Associate II (Dallas, TX)
$67k-89k (estimate)
Full Time | Ancillary Healthcare
Just Posted
AlloSource is Hiring a Clinical Research Associate II (Dallas, TX) Near Dallas, TX
How would you like to grow your skills working for a mission-driven organization while playing an important role in doing more with life? AlloSource is a BioTech company headquartered in Centennial, Colorado.
Here at AlloSource we’re not looking for jobseekers. We want people dedicated to our mission of restoring hope to donor families, and helping patients heal through our innovative cellular and tissue allografts. This takes a special person with a strong desire to help make a tremendous impact on people’s lives. Regardless of which department you work in at AlloSource, we value your efforts, your top-notch skills, and your abilities to contribute to our ultimate goal of saving or enhancing human life! What better reward is there than knowing you contributed, in some way, to save or enhance a person’s life! If this sounds like an organization you wish to be a part of, then we invite you to apply.
SummaryThe Clinical Research Associate II is responsible for the planning, execution, and management of clinical research studies in adherence with GCP and all applicable regulations and guidelines. Develops credible relationships with opinion leaders, sites, and clinical investigators. Acts as a liaison between AlloSource third-party vendors, CRO’s, labs, and IRB’s. Responsible for managing all project deliverables in accordance with established timelines and budgets. Contributes to the development of protocols, relevant study documents, clinical study reports, publications, and leads a clinical team.
Application Deadline May 31, 2024 (100PM MST) Pay $65,836 - $84,398/yr. based upon relevant years of experience
Shift Monday-Friday 800am to 500pm
Benefits Medical, Dental, Vision, Life Insurance. Click link for more benefits details https//cloud.3dissue.net/40523/40398/40838/101256/index.html.html
Location Remote
Essential Duties and Responsibilities
It is the policy of AlloSource not to discriminate against qualified individuals with disabilities in regard to application procedures, hiring, advancement, discharge, compensation, training or other terms, conditions and privileges of employment. When needed we will provide reasonable accommodations to qualified applicants and employees so that they may perform the essential job duties of the position. If you require special accommodations, please contact us at 720-873-0213. For consideration you must apply online, submit a current resume and meet the minimum requirements. AlloSource is a Fair Chance Employer. Candidates within a 50 mile radius of the hiring zip code may receive first consideration.
Equal Opportunity Employer/Veterans/Disabled AlloSource uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
Here at AlloSource we’re not looking for jobseekers. We want people dedicated to our mission of restoring hope to donor families, and helping patients heal through our innovative cellular and tissue allografts. This takes a special person with a strong desire to help make a tremendous impact on people’s lives. Regardless of which department you work in at AlloSource, we value your efforts, your top-notch skills, and your abilities to contribute to our ultimate goal of saving or enhancing human life! What better reward is there than knowing you contributed, in some way, to save or enhance a person’s life! If this sounds like an organization you wish to be a part of, then we invite you to apply.
SummaryThe Clinical Research Associate II is responsible for the planning, execution, and management of clinical research studies in adherence with GCP and all applicable regulations and guidelines. Develops credible relationships with opinion leaders, sites, and clinical investigators. Acts as a liaison between AlloSource third-party vendors, CRO’s, labs, and IRB’s. Responsible for managing all project deliverables in accordance with established timelines and budgets. Contributes to the development of protocols, relevant study documents, clinical study reports, publications, and leads a clinical team.
Application Deadline May 31, 2024 (100PM MST) Pay $65,836 - $84,398/yr. based upon relevant years of experience
Shift Monday-Friday 800am to 500pm
Benefits Medical, Dental, Vision, Life Insurance. Click link for more benefits details https//cloud.3dissue.net/40523/40398/40838/101256/index.html.html
Location Remote
Essential Duties and Responsibilities
- Manage all aspects of the study monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study, initiation visit, conducting on-site and remote monitoring visits.
- Responsible for all aspects of site management as detailed in the project plans.
- General on-site and/or remote monitoring responsibilities.
- Ensure principal investigators and site research staff assigned to study have been properly educated and trained on protocol, have proper material to conduct study, and can safely identify and enroll patients.
- Ensure the protection of study patients by verifying informed consent process and protocols as defined by the regulatory requirements.
- Oversee preparation of Institutional Review Board (IRB) submissions and EC submissions, notification of regulatory authorities, translation of study related documentation, and communication to research study sites.
- Ensure the integrity of the data submitted on (electronic) case report forms by thorough verification of careful and complete source document review.
- Serve as a lead monitor for the project and assist in establishing monitoring plan.
- Monitor data for missing or implausible data and generate queries through resolution.
- Collect, report, and follow-up on serious adverse experiences at clinical research sites.
- Responsible for the oversight of the identification and selection process of investigator sites.
- Responsible for planning and conducting investigator’s meetings in cooperation with the respective departments.
- Contributes to and authors clinical study documents, including but not limited to protocol development, informed consent form, case report forms, clinical study reports, and publications.
- Participate in writing clinical trial reports as assigned.
- Collaborates cross functionally across the organization to achieve corporate goals.
- Develops credible relationships with opinion leaders, sites, and clinical investigators.
- Organize and make presentations at Investigator Meetings.
- Leads, influences, and project manages multiple studies that deliver positive patient and investigator site experiences and quality data.
- Develops and maintains clinical research operating processes, policies, and procedures in support of regulatory compliance.
- Perform interim statistical review and final analysis as assigned and prepare reports.
- Negotiate study budgets with potential investigators and assist in the completion of agreements as assigned.
- Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies.
- May perform other related duties and responsibilities as assigned.
- May travel up to 50% of the time.
- Bachelor’s degree (BS or BA) or Bachelor of Science Nursing Degree (BSN)\
- 2-4 years of clinical trial experience within an FDA regulated industry, specifically tissue banking, medical device, biologics, pharmaceuticals, or CRO industries
- 3 years of project management experience
- Advanced site monitoring skills
- Advanced study site management skills
- Advanced regulatory administration skills
- Ability to work with minimal supervision
- Excellent planning and organizational skills
- Excellent verbal and written communication skills
- Experience working with cross-functional teams
- Ability to train and supervise direct reports
- Ability to resolve project-related problems and priorities workload for self and team
- Work efficiently and effectively in a matrix environment
- Independent, on-site, and remote monitoring experience
- Proficiency in Microsoft Office applications including Word, Excel, PowerPoint
- Graduate degree (life science preferred)
- Project Management Professional (PMP)
- ACRP-PM
- Project Management Certification (PMC)
- Clinical Trial Certification (CCRA, CCRC, CRP)
- Direct experience with all aspects of Clinical Trial Management, and
- Indirect experience with related business functions (regulatory affairs, operations/manufacturing, research & development, marketing & sales)
It is the policy of AlloSource not to discriminate against qualified individuals with disabilities in regard to application procedures, hiring, advancement, discharge, compensation, training or other terms, conditions and privileges of employment. When needed we will provide reasonable accommodations to qualified applicants and employees so that they may perform the essential job duties of the position. If you require special accommodations, please contact us at 720-873-0213. For consideration you must apply online, submit a current resume and meet the minimum requirements. AlloSource is a Fair Chance Employer. Candidates within a 50 mile radius of the hiring zip code may receive first consideration.
Equal Opportunity Employer/Veterans/Disabled AlloSource uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Ancillary Healthcare
SALARY
$67k-89k (estimate)
POST DATE
06/01/2024
EXPIRATION DATE
06/16/2024
WEBSITE
allosource.org
HEADQUARTERS
MARYLAND HEIGHTS, MO
SIZE
200 - 500
FOUNDED
1994
TYPE
Private
REVENUE
$50M - $200M
INDUSTRY
Ancillary Healthcare
Related Companies
About AlloSource
AlloSource is a provider of skin, bone and soft tissue allografts for the medical community.
Show more
The job skills required for Clinical Research Associate II (Dallas, TX) include Clinical Research, Clinical Trial, Integrity, Planning, Organizational Skills, Written Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Research Associate II (Dallas, TX). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Research Associate II (Dallas, TX). Select any job title you are interested in and start to search job requirements.
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The following is the career advancement route for Clinical Research Associate II (Dallas, TX) positions, which can be used as a reference in future career path planning. As a Clinical Research Associate II (Dallas, TX), it can be promoted into senior positions as a Scientist - Clinical Research that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Research Associate II (Dallas, TX). You can explore the career advancement for a Clinical Research Associate II (Dallas, TX) below and select your interested title to get hiring information.
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