Monitor the progress of clinical studies at investigative sites, ensuring studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Coordinate activities to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Identify potential study risks and propose solutions on how to mitigate them.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve therapies for patients, with a focus on Oncology and Rare Disease. They cultivate a culture, and have high CRA retention rates.
Accountable for study level tracking as assigned by the Clinical Project Manager.
Ensures patient enrollment activities are conducted in a timely manner and is comfortable communicating with site personnel.
Acts as QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services.
Akero Therapeutics, a Novo Nordisk company, is focused on discovering and developing transformational treatments for patients with serious metabolic diseases. They are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients.
Assist with investigator recruitment activities and site feasibility tasks.
Perform essential document collection, review, and maintenance activities.
Act as site contact for study and site management issues.
Precision for Medicine supports life sciences companies in the use of precision medicine by helping them design and execute clinical trials. They focus on biomarker-led strategies and have expertise in data science, clinical trial management, and laboratory services.
Conduct and report all types of onsite monitoring visits as well as remote visits.
Perform CRF review, source document verification and query resolution.
Be responsible for site communication and management.
PSI is a dynamic, global, mid-size company founded in 1995, bringing together more than 3,000 driven, dedicated, and passionate individuals. They work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Responsible for timely and quality delivery of site activation readiness, mitigating risks.
Prepare Clinical Trial Application Forms and submission dossiers for regulatory bodies.
Maintain project plans, trackers, and regulatory intelligence tools.
Precision for Medicine is a Clinical Research Organization with an integrated offering that combines clinical trial designs, operational and medical experts, and biomarker and data analytics solutions. They have a passion for rare diseases and oncology, and are growing their team.
Ensure the quality and compliance of clinical trials.
Interpret regulatory requirements.
Lead the development and implementation of quality assurance strategies.
Jobgether is a company, posting this job on behalf of a partner company. They use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements.
Identify and qualify new clinical trial opportunities.
Maintain an accurate early‑stage opportunity pipeline in Salesforce.
Support B2B marketing initiatives by developing materials.
Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. They deliver uncompromising data quality, safety, and diverse enrollment to advance healthcare, believing their people make the difference.
Conduct outbound customer acquisition and marketing activities including emails, calls, and other methods to meet stated goals
Document activity within CRM system (Salesforce)
Achieve minimum productivity goals that include scheduled meetings, and RFPs
Peachtree BioResearch Solutions is a global specialized full-service CRO providing highly specialized study operations teams for pharmaceutical, biotech, and medical device companies. They invest in people who thrive in an environment where their experience and contributions can be felt throughout the organization.
Work with Equip’s Data Science Team and Clinical Leadership to lead the end-to-end design of internal research projects.
Work with Equip’s Data Science Team and Clinical Leadership to meet Equip’s research mission and objectives by performing advanced statistical modeling and analysis.
Manage the lifecycle of IRB submissions and ensure all internal projects adhere to the highest ethical and regulatory standards.
Equip is the leading virtual, evidence-based eating disorder treatment program with a mission to ensure that everyone with an eating disorder can access treatment that works. Founded in 2019, Equip has been a fully virtual company since its inception and is proud of its highly-engaged, passionate, and diverse Equisters that have created Equip’s culture.
Perform discovery visits to access sites for research partnerships.
Provide protocol and product/procedural training to clinical sites.
Assist sites with pre-screening patients to ensure appropriateness for clinical study, as applicable.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our 114,000 colleagues serve people in more than 160 countries, providing a portfolio of life-changing technologies across the spectrum of healthcare.
Responsible for delivery of site activation readiness within the assigned country/sites.
Preparation of Clinical Trial Application Forms and submission dossier for submission to CA, EC, and other applicable local bodies.
Act as SME for collection and maintenance of site level critical path to Site Activation data points.
Precision Medicine Group is an organization that works in the medical field. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Considered as the primary point of contact for the investigative site and strengthens AbbVie’s positioning.
Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision.
Develop solid knowledge of therapeutic area, asset and clinical landscape to enable successful patient recruitment.
AbbVie discovers and delivers innovative medicines and solutions that solve serious health issues. They strive to have a remarkable impact on people's lives across several key therapeutic areas.
Lead the planning, execution, and management of clinical trials.
Ensure compliance with FDA, ICH-GCP, and other regulatory standards.
Supervise and mentor Clinical Research Associates (CRAs) and study coordinators.
Jobgether leverages AI to match candidates with fitting roles, ensuring quick and fair application reviews. They connect top candidates directly with hiring companies, who then manage the final decision-making process.
Serves as the clinical trial lead responsible for the planning, conduct and oversight of clinical studies.
Develop study related clinical documents and generate potential site list from key stakeholders.
Manage processes for investigational product including drug accountability and reconciliation.
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences to improve the speed, cost and success rate of bringing therapies to patients. They focus on Oncology and Rare Disease, providing deep scientific knowledge.
Support Dosing Program Lead across assets and may serve as dosing program representative on clinical trial teams
Contribute to the writing and editing of clinical study protocols, clinical study reports, manuscripts, and other study-related documents
Contribute to ongoing data review and cleaning, data summarization and analysis in support of abstracts, manuscripts and presentations for external meetings and conferences
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding their presence and global footprint with a team of patient-centric, intelligent individuals.
Bring medical and scientific expertise to the design, execution, and interpretation of clinical studies ensuring patient safety and scientific integrity
Author and oversee key clinical documents including protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions
Review, analyze, and interpret emerging clinical data (safety, efficacy, PK/PD) to identify trends and issues, ensuring timely resolution through cross-functional collaboration
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding our presence and global footprint, searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team.