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Clinical Research Coordinator I
Summary
This position is for someone interested in joining a research coordination team within the Clinical Trials Office (CTO) at the MaineHealth Institute for Research, Scarborough, ME. This position provides clinical research coordination support for a dynamic and fast-paced team within the CTO. The clinical research coordination team contributes to research by facilitating clinical research – ensuring research is conducted in a manner to protect research participant safety and promote the ethical conduct of research throughout the MaineHealth network. Under the supervision of the Manager – Non Oncology, the Clinical Research Coordinator I will facilitate studies by coordinating study related activities with other departments and staff. This responsibility will extend to the preparation of personnel, study materials and files to ensure study visits and procedures are run efficiently and that study procedures are completed according to protocol. The Clinical Research Coordinator I is expected to effectively collaborate with study Principal Investigators, Clinical Coordinators, and external and internal regulatory bodies. Strong organizational and communication skills as well as attention to detail are necessary for success. This role requires general knowledge of clinical research coordination, initiative, independent judgment, and discretion.
A flexible on-site/off-site work schedule may be available for this position.
The MaineHealth application, cover letter and a resume or CV are all required elements for application to this position.
Required Minimum Knowledge, Skills, and Abilities
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Education: High School Diploma preferred. Associate’s Degree preferred.
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License/Certifications: Certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred.
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Experience: N/A
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Ability to function independently and as part of a team.
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Excellent communication skills, verbal and written.
#178620
Clinical Research Coordinator II – Oncology Trials
Summary
This position is for someone interested in joining a dynamic and fast-paced team within the Oncology Clinical Trials Office at the MaineHealth Institute for Research, Scarborough, ME. This team is contributing to research at MaineHealth by managing the studies that take place at multiple MaineHealth Cancer Care Network (MHCCN) sites/clinics. Our team is specifically responsible for successful implementation of many of the cancer screening and prevention studies. This is a clinical and technical position responsible for coordinating clinical research. Under the general supervision of the team’s Research Program Manager, this Clinical Research Coordinator II will coordinate the activities of enrollment and data collection for a wide range of protocol designs, while ensuring patient safety and protocol compliance. They will be expected to collaborate with study Principal Investigators, Program Coordinators, Study Centers, and colleagues in relevant MaineHealth departments. Strong organizational and communication skills are necessary for success.
The 1) MaineHealth application, 2) a cover letter and 3) a resume or CV are all required elements for application to this position.
This position may be accomplished fully onsite in Scarborough, ME or after an introductory period, by a hybrid schedule of onsite/offsite work.
Required Minimum Knowledge, Skills, and Abilities
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Education: Bachelor’s degree in a health science or related field required.
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License/Certifications: Certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred.
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Experience: 2 years of clinical experience in a healthcare setting required.
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Knowledge of basic statistical principles and methods.
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Ability to function independently and as part of a team.
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Excellent communication skills, verbal and written.
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Demonstrable computer competency in Microsoft Word and Excel.
#180360
Clinical Research Nurse Coordinator
Summary
- Position Summary
- The Research Nurse Coordinator is responsible for the execution and conduct of Clinical trials while following FDA and GCP regulations and guidance. The Research Nurse Coordinator will collaborate with the Sponsor, Regulatory team, Principal Investigator, Sub-investigators, other study personnel and the outpatient departments where this study is being conducted. Study coordination tasks include identifying, screening and confirming eligibility of potential study patients, conducting an informed consent discussion with potential patients, coordinating study visits and procedures, following patients for safety throughout the study, collecting and entering data into appropriate electronic data capture systems, maintaining regulatory documents and closing out the study at its completion.
- Regulatory/Compliance Management
- Conducts all research activities within an ethically based framework and in accordance with good clinical practice, i.e. federal, state, and institutional requirements; maintains all institutional and regulatory documents, including IRB documents, grants, contracts, study data, patient charts, and financial records.
- Develops and/or evaluates new research protocols, considering feasibility of conduct as the site.
- Collaborates with other departments to plan and implement relevant aspects of the protocol.
- Assures subject safety throughout the clinical trial.
- Research Project Management
- Participates in all aspects of a research study, including but not limited to: assist in budget development, site initiation, informed consent process, test articles accountability, study closeout.
- May perform other duties as assigned.
Required Minimum Knowledge, Skills, and Abilities
- Education: See “License/Certifications”
- License/Certifications: Current license to practice as a Registered Nurse in the State of Maine.
- Experience: N/A
- Interpersonal and communication skills to interact effectively with patients, families and other healthcare providers. Ability to collaborate with multiple disciplines and departments.
- Knowledge of current research related policies and procedures as well as appropriate process for initiating revisions.
- Thorough knowledge of theory, practice, principles, processes and issues of nursing usually acquired through 2-3 years of clinical experience.
- Analytical ability necessary to keep records, maintain inventory levels and perform data entry.
- Ability to manage complex projects through all phases of development, implementation, and follow-up.
#175295
Clinical Research Nurse Coordinator – Oncology
Summary
- This position is for someone interested in joining a hands-on team at the MaineHealth Institute for Research, which is contributing to biomedical research in the area of Oncology. Our team is specifically interested in therapeutic trials testing various combinations of chemotherapy, immunotherapy, targeted therapy, and radiation therapy. The Research Nurse Coordinator position involves all aspects of research coordination, actively pre-screening and enrolling patients, scheduling study assessments, clinical data management, and communication with the study sponsor. This includes collaboration with the Principle Investigator, Program Coordinator, Study Center, and relevant MMC Departments. The primary responsibilities include study coordination and acting as a hospital educator/resource person for studies. The primary characteristics of a successful Clinical Research Nurse Coordinator include attention to detail, highly organized, and excellent communication skills.
- A hybrid work schedule is available for this position.
Required Minimum Knowledge, Skills, and Abilities
- Education: See “License/Certifications”
- License/Certifications: Current license to practice as a Registered Nurse in the State of Maine.
- Experience:N/A
- Interpersonal and communication skills to interact effectively with patients, families and other healthcare providers. Ability to collaborate with multiple disciplines and departments.
- Knowledge of current research related policies and procedures as well as appropriate process for initiating revisions.
- Thorough knowledge of theory, practice, principles, processes and issues of nursing usually acquired through 2-3 years of clinical experience.
- Analytical ability necessary to keep records, maintain inventory levels and perform data entry.
- Ability to manage complex projects through all phases of development, implementation, and follow-up.
#170701
Clinical Trials Budget Analyst II
Summary
This position is for someone interested in joining a financial operations team within the Clinical Trials Office at the MaineHealth Institute for Research, Scarborough, ME. The Financial Operations team contributes to research at MaineHealth by collaborating with clinical research and project teams on forecast preparation, variance analysis, and collecting and analyzing data to implement strategies for cost savings and planning. Under the general direction of the Manager of Clinical Trials Research Operations, the Budget Analyst II will take on primary responsibility for managing the daily business and financial activities of clinical trials assigned to them. The Budget Analyst supports a broad range of research operations management including Research Counsel, Sponsored Research, Accounting Management, and Financial/Business Operations. Successful support will require skills in RedCap, EMR, and CTMS navigation and fiscal reporting, for timely study and project status updates. This role requires general knowledge of clinical research coordination, initiative, independent judgment, and discretion.
A fully remote or flexible on-site/off-site work schedule is available for this position.
The MaineHealth application, cover letter and a resume or CV are all required elements for application to this position.
Required Minimum Knowledge, Skills, and Abilities
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Education: Bachelor’s Degree in a related field or 3 years experience as a Clinical Trials Budget Analyst. Master’s Degree preferred.
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License/Certifications: N/A
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Experience: A minimum of 3-5 years of work experience with clinical trials, or a combination of clinical trials and relevant work experience required; A minimum of 2-3 years direct experience budgeting and estimating clinical trials costs; Must have working knowledge of clinical trials via 1-2 years of industry or site experience
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Must understand what is standard of care or routine care and what is considered research-related in the context of a clinical trial
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Excellent organizational skills, ability to prioritize work independently with strong attention to detail and superior analytical and problem-solving skills
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Ability to work in collaboration with ancillary teams, departments, investigators, research staff, supporting administration, and sponsors/funding agencies.
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Provide excellent customer service while maintaining accurate results in a fast-paced, deadline-driven team environment.
#179256
Leade Clinical Research Coordinator – Regulatory Trainer
Summary
- This position provides comprehensive staff training support for a dynamic and fast-paced team within the Clinical Trials Office at the MaineHealth Institute for Research, Scarborough, ME. The training team contributes to research by ensuring research personnel have the appropriate training and education to protect research participant safety and promote the ethical conduct of research throughout the MaineHealth network. Responsibilities include taking a lead role in training and ongoing operations support of other Research Coordinators. Under the supervision of the Manager – Regulatory Affairs and Quality, the Lead Research Coordinator Trainer will plan, coordinate and implement initial orientation and ongoing training, education and professional development programs for Research Staff. They are expected to effectively collaborate with study Principal Investigators, Clinical Coordinators, and external and internal regulatory bodies. Strong organizational and communication skills as well as attention to detail are necessary for success.
- The MaineHealth application, cover letter and a resume or CV are all required elements for application to this position.
Required Minimum Knowledge, Skills, and Abilities
- Education: Bachelor’s degree in a health science or related field required.
- License/Certifications: Certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred.
- Experience: 2 years of clinical experience in a healthcare setting required.
- Knowledge of basic statistical principles and methods.
- Ability to function independently and as part of a team.
- Excellent communication skills, verbal and written.
- Demonstrable computer competency in Microsoft Word and Excel.
#176013
Research Assistant I – Rosen Lab/RECOVER Study
Summary
This is a clinical and technical position important for coordinating clinical research. This position is for someone interested in joining a research coordination team within the MaineHealth Institute for Research – Rosen Lab – RECOVER Study Team, Scarborough, ME. RECOVER is a government-funded study that aims to understand Long COVID. This position provides research coordination that involves:
– Lab data entry into study database (REDCap)
– Transporting bio-specimen from NorDx to MHIR (lab)
– Labeling bio-specimen KITs for in-person visits
– Survey follow-up for participants via email
– Copying Informed Consent Forms and scanning documents into EPIC
– Attending weekly calls
– Submitting weekly notification emails to MHIR finance group
– Uploading participant reimbursements for completed testing
– Liaison for participant diagnostic scheduling
– Uploading Chest CT’s, ECHO’s and Brain MRI imaging to database
– Completing some office-based test with study participants (i.e. 6-minute walk test, Vision test and Smell test)
RECOVER is a human (non-animal) study, and this position supports the study fully on-site at our Scarborough, ME location.
Required Minimum Knowledge, Skills, and Abilities
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Education: High school diploma preferred. Bachelor’s degree preferred.
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License/Certifications: N/A
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Experience: No prior years of relevant experience required.
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Interpersonal skills necessary to communicate and work effectively.
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Visual acuity, manual dexterity, math skills and a scientific acumen are required.
#178949
Research Fellow – Guntur Lab
Summary
Required Minimum Knowledge, Skills, and Abilities
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Education: A doctoral degree (e.g. PhD, MD, DO, DVM, PharmD)
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License/Certifications: N/A
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Experience: N/A
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The ability to comply with research regulations, standards, and policies, and established skills in good laboratory practice, data collection and analysis.
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Communication skills that are sufficiently developed that the individual at this level will be able to present research results at regional and national research conferences
#180425
Research Fellow – Pinz Lab
Summary
Required Minimum Knowledge, Skills, and Abilities
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Education: A doctoral degree (e.g. PhD, MD, DO, DVM, PharmD)
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License/Certifications: N/A
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Experience: N/A
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The ability to comply with research regulations, standards, and policies, and established skills in good laboratory practice, data collection and analysis.
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Communication skills that are sufficiently developed that the individual at this level will be able to present research results at regional and national research conferences
#177133