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Senior Clinical Research Associate
Clinical Research Manager
Job Descriptions
TITLE: Senior Clinical Research Associate
Summary:
Responsible for overseeing all clinical activities related to one or more clinical trials and performing or managing daily in-house operations associated with the trials. This position should be able to independently handle various clinical study assignments.
Major Responsibilities:
- Research, prepare, and update clinical protocols, instructions for use, informed consents, reports of prior investigations, bibliography, case report forms, clinical trial reports, and other study-related documents in consultation with the cross-functional project team, investigators, data management, and biostatistics.
- Responsible for coordination/execution of all operational aspects of clinical studies, including study start-up, patient enrollment and follow up, study closure activities.
- Develop and manage study budgets, timelines, and resource requirements. Manage all outsourced activities for assigned trials. Provide management level representation during audits.
- May perform monitoring and auditing at participating sites, CROs, Core Labs, etc., to ensure compliance with the Investigational Plan and appropriate regulations, guidelines, and policies.
- Conduct ongoing review of adverse event information. Compile and update adverse event logs. May interface with regulatory agencies, as appropriate.
- Conduct/supervise training of investigators, site staff, and internal clinical staff. Conduct/supervise site initiation activities. Set-up and maintain (or supervise) accurate study status and accountability logs.
- Review data listings and tables. Educate internal/external data management on the clinical context of these documents and provide oversight of data reconciliation.
- Evaluate clinical data/information, write, and revise annual, interim, and final reports and clinical sections of regulatory submissions.
- May organize investigator conferences to review findings and advise on study direction, as needed.
- May provide input and support for post-clinical activities and market launch of products.
Requirements:
- Minimum BS in biology or healthcare required. M.S. or Ph.D. preferred.
- Clinical Research 2 - 5 years, in device, biotech, pharma, or CRO setting. Experience managing clinical trials from protocol development to final report.
- Strong understanding of plastic and reconstructive surgery, implants, prostheses, and related products.
- Strong knowledge of Good Clinical Practice (GCP) and US and international regulations for clinical trials.
- Ability to travel up to 50%, internationally and within the US.
Personal Attributes:
- Organized and detail-oriented.
- Strong motivator/communicator in a compact clinical team working with aggressive timelines.
- Good communication/negotiation skills with clinical investigators and academic thought leaders; highly professional demeanor.
- Advanced written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.
- Strong Computer skills (MS Office products, word processing, spreadsheets, etc.).
- Ability to multi-task. Strong prioritization and organizational skills.
- Strong problem solving skills.
TITLE: Clinical Research Manager
SUMMARY:
Responsible for overseeing all clinical activities related to one or more clinical trials and performing or managing daily in-house operations associated with these trials. This position should be able to independently handle various clinical study assignments. May have supervisory responsibility for Clinical Research Associates and/or Clinical Research Assistants, as required.
MAJOR RESPONSIBILITES:
- Research, prepare, and update clinical protocols, instructions for use, informed consents, reports of prior investigations, bibliography, case report forms, clinical trial reports, and other study-related documents in consultation with the cross-functional project team, investigators, data management, and biostatistics.
- Responsible for coordination/execution of all operational aspects of clinical studies, including study start-up, patient enrollment, follow up, and study closure activities. Develop and manage study budgets, timelines, and resource requirements. Manage all outsourced activities for assigned trials. Provide management level representation during audits.
- May perform monitoring and auditing at participating sites, CROs, Core Labs, etc., to ensure compliance with the Investigational Plan and appropriate regulations, guidelines, and policies.
- Conduct ongoing review of adverse event information. Compile and update adverse event logs. May interface with regulatory agencies, as appropriate.
- Conduct/supervise training of investigators, site staff, and internal clinical staff. Conduct/supervise site initiation activities. Set-up and maintain (or supervise) accurate study status and accountability logs.
- Review data listings and tables. Educate internal/external data management on the clinical context of these documents and provide oversight of data reconciliation.
- Evaluate clinical data/information, write, and revise annual, interim, and final reports and clinical sections of regulatory submissions.
- May oversee clinical research staff and perform personnel related supervisory duties (e.g., performance assessments, development of staff goals and objectives).
- May organize and direct investigator conferences to review findings and advise on study direction, as needed.
- May co-author results of studies for medical literature and/or presentations at scientific meetings.
- Provide input and support for post-clinical activities and market launch of products.
- As clinical research management representative, interface with representatives from other key functional groups including Research and Development, Regulatory Affairs, Marketing, Legal and other groups.
REQUIREMENTS:
- Minimum BS in biology or healthcare required. M.S. or Ph.D. preferred.
- Clinical Research 5 - 7 years, in device, biotech, pharma, or CRO setting. Experience managing clinical trials from protocol development to final report. Experience with post-marketing studies would be advantageous.
- Management experience 2 - 3 years.
- Experience working with international and US regulatory bodies, such as Notified Bodies, Competent Authorities, EMEA, or FDA.
- Strong understanding of plastic and reconstructive surgery, implants, prostheses, and related products.
- Additionally, understanding of interventional cardiology or cardiac surgery is advantageous but is not necessary.
- Knowledge of principles of clinical research study design and approaches to statistical analysis.
- Strong knowledge of Good Clinical Practice (GCP) and US and international regulations for clinical trials.
- Ability to travel up to 50%, internationally and within the US.
PERSONAL ATTRIBUTES:
- Organized and detail-oriented.
- Strong motivator/communicator in a compact clinical team working with aggressive timelines.
- Good communication/negotiation skills with clinical investigators and academic thought leaders; highly professional demeanor.
- Advanced written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.
- Strong Computer skills (MS Office products, word processing, spreadsheets, etc.).
- Ability to multi-task. Strong prioritization and organizational skills.
- Strong problem solving skills.