Director Of Clinical Research Resume Samples

Description :

1. Developed and implemented strategic plans for clinical research programs in alignment with organizational goals and objectives.
2. Oversaw the design, development, and execution of clinical research protocols, ensuring adherence to ethical standards and regulatory requirements.
3. Managed clinical trial operations, including site selection, investigator recruitment, patient enrollment, and data collection.
4. Provided leadership and guidance to clinical research staff, including training, performance management, and professional development.
5. Collaborated with internal and external stakeholders, including physicians, scientists, regulatory agencies, and vendors, to drive research initiatives forward.
6. Ensured compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and other relevant regulations and standards.
7. Managed clinical research budgets, including forecasting expenses, tracking expenditures, and optimizing resource allocation.

Experience

7-10 Years

Level

Consultant

Education

DCR

Description :

1. Provided medical and scientific insight to the publications, supporting Medical Affairs activities, and representing Crinetics to a diverse range of academic, regulatory, and patient organizations.
2. Developed a Clinical Development Plan (CDP) for the indication of interest, built consensus and got approval from the Executive Team. 
3. Contributed to the Strategic plans and Target Product Profile (TPP). This will involve focused multidisciplinary internal and external consultation and strategic planning.
4. Led the design, planning, and implementation of clinical trials consistent with this CDP and presented for feedback/approval to internal executive committees.
5. Authored clinical protocols (and in its early stages clinical trial outlines (CTO) and synopses) amendments and related documents.
6. Collaboratively assisted in drawing up project development timelines in coordination with other functions represented on the development team, and provided timely updates to the development team.
7. Provided medical monitoring for clinical studies in collaboration with CRO medical monitors.

Experience

5-7 Years

Level

Executive

Education

MD

Description :

1. Participated in ongoing and formal data analyses and reviews for CSR completion and planned/actual filing activities.
2. Contributed to the development of clinical sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND/BLA submission documents, and responses to Health Authorities questions.
3. Led trial-related advisory boards, investigator meetings, and protocol training meetings.
4. Collaborated with medical affairs and commercial members to develop effective working relationships with key investigators, key opinion leaders, and patient advocates to optimize scientific quality/innovation of clinical study design, execution, reporting, and publication.
5. Provided medical/clinical expertise to publications planning and drafting.
6. Provided oversight and project management of clinical programs including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Crinetics SOPs.
7. Attended conferences and remained current with relevant therapeutic area information.

Experience

7-10 Years

Level

Senior

Education

MD

Description :

1. Attended and participated in study-specific meetings such as Site Initiation Visits, Dose Review Committee Meetings, Investigator Meetings, and/or Safety Review Committee Meetings.
2. Performed medical review, assessment, and interpretation of clinical and safety data to evaluate regulatory reporting requirements and ensure appropriate medical interpretation.
3. Worked closely with Pharmacovigilance and Safety representatives, providing medical input into safety reports including SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs), and Suspected Unexpected Serious Adverse Reaction (SUSAR) reports.
4. Developed study-specific Medical Monitoring Plan.
5. Reviewed the patient lab and adverse event line listings for coding, protocol deviations, and safety issues.
6. Attended regular internal and sponsor team meetings.
7. Developed departmental processes to achieve objectives towards department and corporate goals.

Experience

7-10 Years

Level

Senior

Education

MD

Description :

1. Reviewed and comprehended the protocol, investigator brochures (when applicable), and all study-related manuals/guidelines and assisted study staff in understanding of these items.
2. Reviewed and developed a familiarity with the protocol, such as study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
3. Prepared and/or oversaw the creation of study-related documentation, including but not limited to source documents, adverse event reports, and progress notes.
4. Oversaw the establishment and organization of study files, including but not limited to study-specific source documentation and other materials.
5. Attended investigator meetings as required or requested by the PI.
6. Provided availability as requested by management for after-hours urgent calls from study subjects to ensure subject safety.
7. Assisted PI in communicating study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members documents the date of training and signatures of study personnel trained on the study-specific training log.

Experience

7-10 Years

Level

Consultant

Education

DCR

Description :

1. Obtained appropriate signatures and dates on forms in appropriate places. 
2. Assured that amended consent forms were appropriately implemented and signed.
3. Conducted procedural aspects of studies, including standards of care, informed consent procedures, and documentation procedures.
4. Screened subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
5. Recorded adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies.
6. Collected data as required by the protocol and ensured timely completion of Case Report Forms.
7. Notified appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events.

Experience

10+ Years

Level

Management

Education

DCR

Description :

1. Maintained all study records, including but not limited to case report forms, drug dispensation records, or regulatory forms following sponsor requirements and Clinical Trials Center of Middle Tennessee, LLC policies and procedures.
2. Tracked enrollment status of subjects and documented dropout information such as dropout causes and subject contact efforts.
3. Participated in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. 
4. Identified protocol problems, informed investigators of problems, or assisted in problem-solving efforts such as protocol revisions.
5. Collaborated with PI and Institution to respond to audit findings and implement approved recommendations.
6. Notified appropriate institutional officials of external audits by the FDA and sponsors and assisted the CEO with Human Resource responsibilities including interviewing, onboarding, and training of new employees, as well as providing ongoing oversight and support.
7. Led the direct negotiation of clinical trial agreements and provided oversight of the applicable amendments and site-level negotiation process to ensure ethical, fair, and compliant practices were followed when developing, negotiating, and executing clinical agreements.

Experience

5-7 Years

Level

Executive

Education

MD

Description :

1. Provided the study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance, and patient safety at the trial, site, and patient level.
2. Ensured development of and adherence to the Safety Surveillance Review Plan (SSRP). 
3. Performed and documented regular review of individual subject safety data, and reviewed cumulative safety data with the safety risk lead.
4. Monitored study safety issues and provided input to serious adverse events (SAEs) reports.
5. Provided appropriate medical context in terms of risk factors, medical history, and other important medical factors required to put the SAE or AE into the appropriate medical context required for benefit-risk assessments.
6. Participated in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications.
7. Reviewed literature as needed to respond to safety questions or those posed by the Safety Review Team, Data Monitoring Committee (DMC), or other individuals or bodies involved with the study.

Experience

7-10 Years

Level

Senior

Education

MD

Description :

1. Provided clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, and data quality planning, as needed (ultimately oversees work of protocol/study team).
2. Contributed to contract research organization/vendor selection to ensure the study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines, this includes ensuring medical/technical requirements for data integrity are applied.
3. Worked with the study team to ensure high quality of data appropriate patient population, and adequacy of clinical assessments as the study is ongoing.
4. Conducted medical review and interpretation of efficacy and safety data from clinical trials, this may include delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountability for overall quality and timeliness of analysis and reporting.
5. Ensured the medical and scientific validity of the study report, especially conclusions regarding efficacy and safety, responsible for disclosure of appropriate safety and efficacy data and conclusions.
6. Provided protocol-specific training to the study team, investigators, clinical research associates, and others.
7. Interacted with healthcare professionals at sites (leveraging the RMMs when assigned) during the conduct of the study to enable quality, compliance, and patient safety at the trial, site, and patient levels.

Experience

5-7 Years

Level

Executive

Education

MD

Description :

1. Served as a Medical Director for the oncology clinical trials.
2. Led multidisciplinary teams of trial operations and development experts to provide medical input and support.
3. Provided input on scientific and/or medical considerations for proposals and/or protocols.
4. Participated in bid defense meetings for potential projects.
5. Provided applicable therapeutic area training to the team.
6. Provided therapeutic area and/or protocol training for site staff.
7. Provided medical oversight for assigned clinical trials including review of subject eligibility, cohort management, and/or review and responding to protocol-related questions.

Experience

7-10 Years

Level

Senior

Education

MD