Current jobs related to Clinical Specialist - Albany - Master Compliance

  • Clinical Specialist

    2 months ago

    Albany, United States Catholic Charities of the Dioscese of Albany Full time

    We're looking for great people like you! Clinical Specialist, Albany General Information Job Title: Clinical Specialist Location: Albany, NY, 12203, United States Base Pay: $18.55 - $18.55 / Hour Job Category: Catholic Charities Disabilities Services Description Catholic Charities is an organization that values helping others at any stage in their life,...

  • Clinical Specialist

    1 week ago

    Albany, New York, United States Catholic Charities Full time

    Clinical Specialist Job DescriptionAbout the Role:We are seeking a skilled Clinical Specialist to join our team at Catholic Charities. As a Clinical Specialist, you will be responsible for assisting the Nurse Manager, RN's and LPN's with managing the healthcare needs of individuals served in our Residential Program.Key Responsibilities:* Assist with managing...

  • Clinical Specialist

    2 weeks ago

    Albany, New York, United States Catholic Charities Full time

    Clinical Specialist Job DescriptionCatholic Charities is a leading organization dedicated to providing support and services to individuals in need. We are seeking a highly skilled Clinical Specialist to join our team in our Catholic Charities Disabilities Services agency.Key Responsibilities:Collaborate with Nurse Managers, RNs, and LPNs to manage the...

  • Clinical Nutrition Specialist

    1 month ago

    Albany, New York, United States RD NUTRITION CONSULTANTS LLC Full time

    Job Title: Clinical Nutrition SpecialistRD Nutrition Consultants LLC is seeking a highly skilled Clinical Nutrition Specialist to join our team. As a key member of our team, you will be responsible for providing comprehensive nutrition care to patients in a clinical setting.Key Responsibilities:Conduct comprehensive nutrition assessments using the Nutrition...

  • Clinical Quality Specialist

    3 days ago

    Albany, New York, United States Baptist Health Full time

    Job Description:The Clinical Quality Specialist at Baptist Health conducts on-site clinical reviews of cases referred by case management staff and/or other healthcare professionals to meet regulatory requirements and in accordance with the hospital's objectives for assuring quality patient care and effective, efficient utilization of healthcare services.The...

  • Clinical Nutrition Specialist

    1 week ago

    Albany, New York, United States RD NUTRITION CONSULTANTS LLC Full time

    Nutrition Care SpecialistRD Nutrition Consultants LLC is seeking a Clinical Nutrition Specialist to join our team. As a Clinical Nutrition Specialist, you will be responsible for conducting comprehensive nutrition assessments, developing and implementing individualized plans for Medical Nutrition Therapy (MNT), and providing nutrition education and...

  • Clinical Services Specialist

    7 days ago

    Albany, New York, United States Northern Rivers Family of Services Full time

    Job SummaryClinical Services Specialist - Day TreatmentNorthern Rivers Family of Services is seeking a skilled Clinical Services Specialist to provide clinical services to children and their families in a Day Treatment setting. As a key member of our interdisciplinary team, you will work collaboratively to develop and implement comprehensive treatment plans...

  • Clinical Specialist

    3 days ago

    Albany, New York, United States Catholic Charities of the Dioscese of Albany Full time

    Catholic Charities of the Diocese of Albany is seeking a Clinical Specialist to join our team in the Disabilities Services agency. As a Clinical Specialist, you will be responsible for assisting the Nursing Supervisor, RNs, and LPNs with managing the healthcare needs of individuals served in our Residential Program.Key responsibilities include:Assisting with...

  • Clinical Support Specialist

    3 weeks ago

    Albany, New York, United States CDPHP Full time

    Job Title: Clinical Support SpecialistClinical Support Specialists play a vital role in ensuring the smooth operation of our healthcare services. As a member of our team, you will provide administrative support to clinical staff, adhering to established customer service standards of accuracy, courtesy, and professionalism.Key Responsibilities:Provide timely...

  • Clinical Nurse Specialist

    1 month ago

    Albany, New York, United States Albany Medical Center Full time

    Clinical Nurse Specialist **Job Summary:** We are seeking a skilled Clinical Nurse Specialist to join our Surgical Care team at Albany Medical Center. As a key member of our team, you will be responsible for providing high-quality patient care and contributing to the development of our surgical services. **Responsibilities:** * Assess and evaluate...

  • Clinical Nutrition Specialist

    1 month ago

    Albany, Georgia, United States MLee Healthcare Staffing and Recruiting, Inc Full time

    MLee Healthcare Staffing and Recruiting, Inc is seeking a skilled Clinical Nutrition Specialist to collaborate with a dynamic team at a reputable hospital in Georgia. As a key member of the healthcare team, you will work closely with physicians, nurses, and other professionals to provide comprehensive nutrition assessment and intervention for patients. Your...

  • Clinical Prevention Specialist

    7 days ago

    Albany, New York, United States Catholic Charities of the Diocese of Albany Full time

    Job SummaryCatholic Charities of the Diocese of Albany is seeking a skilled Clinical Prevention Specialist to join our Clinical Prevention Team. The successful candidate will work with families in Albany County who are at risk of foster care placement, providing assessment, treatment planning, case management, and home-based counseling.Key responsibilities...

  • Clinical Nurse Specialist

    4 days ago

    Albany, New York, United States Albany Medical Center Full time

    Job Summary:We are seeking a compassionate and caring Clinical Nurse Specialist to administer medications, perform treatments, and collaborate with the nursing team to create a Plan of Care for all patients.Key Responsibilities:Administer medications and perform treatments as prescribed by physiciansCollaborate with the nursing team to develop and implement...

  • Clinical Laboratory Specialist

    3 weeks ago

    Albany, New York, United States Albany Medical Center Full time

    Job SummaryAlbany Medical Center seeks a skilled Clinical Technical Specialist to join our team. As a technologist in clinical laboratory/cytology/histology, you will perform procedures/tests to aid in the detection and diagnosis of disease and/or monitor progress of defined illnesses or treatments initiated by a physician.Key ResponsibilitiesExercise...

  • Clinical Office Specialist

    2 weeks ago

    Albany, New York, United States Samaritan Health Services Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Office Specialist to join our team at Samaritan Health Services. As a key member of our neuropsychology department, you will be responsible for providing exceptional administrative support to our clinical staff and patients.Key ResponsibilitiesProvide receptionist duties and clerical...

  • Clinical Assessment Specialist

    4 days ago

    Albany, New York, United States AltaStaff Full time

    Job SummaryWe are seeking a skilled Nurse Practitioner to join our team at AltaStaff. As a Clinical Assessment Specialist, you will be responsible for reviewing and making recommendations on consumer assessments for long term care services and supports.Key Responsibilities• Review and validate assessment outcomes• Maintain current knowledge of regulatory...

  • Clinical Laboratory Specialist

    4 weeks ago

    Albany, New York, United States Albany Medical Center Full time

    Job SummaryThe Clinical Technical Specialist is a key member of our laboratory team, responsible for performing complex laboratory tests and procedures to aid in the detection and diagnosis of diseases. This role requires strong technical expertise and the ability to work independently with minimal supervision.Key Responsibilities* Perform a variety of...

  • Hematology Clinical Account Specialist

    4 weeks ago

    Albany, New York, United States AbbVie Full time

    Job Title: Hematology Clinical Account SpecialistAbbVie is seeking a highly motivated and experienced Hematology Clinical Account Specialist to join our team. As a key member of our sales team, you will be responsible for building and maintaining strong relationships with hematologists and oncologists, as well as other healthcare professionals, to promote...

  • Clinical Care Specialist

    4 days ago

    Albany, New York, United States Atlas MedStaff Full time

    Atlas Medstaff OpportunityWe are seeking a skilled Clinical Care Specialist to join our team in the Albany, New York area for a 26 week contract. Our commitment to excellence and consultative approach has helped us become a premier leader in the staffing industry.The estimated compensation package is based on a usual week of work, inclusive of taxable hourly...

  • Oncology Haematology Clinical Nurse Specialist

    2 months ago

    Albany, New York, United States Government of Western Australia Full time

    Clinical Nurse Specialist - Oncology HaematologyCompany Name: Government of Western AustraliaAre you a dedicated healthcare professional seeking a fulfilling role in a vibrant regional setting?This is an excellent opportunity for qualified international candidates looking to contribute to healthcare excellence.About UsThe Government of Western Australia is...

Clinical Specialist

2 months ago

Albany, United States Master Compliance Full time

Only W2 (No C2C)


Job Description:


One of our Clients is a large biotechnology company looking for a SME to help them support their batch record releases. They have commercial sites in the US and are working on their commercial space in Canada. Their site in Canada has several clinical studies that they are doing a first-time release. They need someone who knows the Health Canada Guidelines well, and someone who has or can make trainings for them. They want to understand what the difference is between what they are currently doing and what they are expected to be doing (like a gap assessment).


Responsibilities:


  1. Knowledgeable of GUI-0036 Guidance Document - Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines Drugs Used in Clinical Trials
  2. Especially section, 10.0 Release of batches and how to execute and document the requirements of this section
  3. Able to produce documentation that satisfies section 11, step 44: Investigational medicinal products should remain under the control of the Sponsor until after completion of a two step release procedure: certification by the Qualified Person; and release following fulfillment of the relevant requirements. The sponsor should ensure that these are consistent with the details considered by the Qualified Person. Both releases should be recorded and retained in the relevant trial files held by or on behalf of the sponsor.
  4. Experience generating label reviews
  5. Understanding of what is required for label reviews and potentially have pre-prepared templates that can be utilized.
  6. Expert in GUI-0036 and GUI-0100 regulations
  7. Understanding of Clinical GMP expectations, and systems in place that REGN can utilize for release by the consultant
  8. Experienced in hosting Audits by Health Canada
  9. And their processes be in place and in use for previous clients that have been audited
  10. Able to provide training to Client Personnel on GUI0036 and GUI-0100, including Health Canada audit expectations, and differences between FDA and Health Canada expectations
  11. Able to consult Client for setting up of applicable inhouse systems
  12. Able to identify gaps in Client’s processes, so that they can be remediated
  13. Potential to write reports identifying gaps and other applicable requirements that are necessary.