Medical researcher job description
This post includes 3 parts: duties list, job qualification and job description writing tips for Medical researcher in details. A complete jo...
https://teachingtips247.blogspot.com/2013/07/medical-researcher-job-description.html
This post includes 3 parts: duties list, job qualification and job description writing tips for Medical researcher in details. A complete job description concludes Medical researcher key duties/responsibilities, Medical researcher job qualifications (knowledge, education, skills, abilities, experience…KSA model) and other ones such as daily tasks, key activities, key/core competencies, job functions/purpose…
I. List of Medical researcher duties:
1) Develop (with the Executive Director of Clinical Research) a comprehensive pre-clinical and clinical research strategy covering near and long-term actions for development of DHA products consistent with marketing needs
2) Handle design and implementation of preclinical and clinical studies conducted under IND regulations and/or for support for NDA submissions (as needed)
3) Present aspects of the medical clinical research program to the Research Management Committee – Clinical
4) Develop written reports and make oral presentations
5) Work with Discovery Team to evaluate potential new or under-explored benefits of DHA
6) Develop and maintain plans for staffing and budget for Medical Research in consultation with the Executive Director of Clinical Research
7) Support the research program based upon a pre-determined strategy of what capabilities the company must have in–house and what may reasonably be outsourced
8) Build and maintain the Medical Research staff and assist with training
9) Maintain Clinical Research as a Good Clinical Practice operation with active, up to date, SOPs and training of staff
10) Provide medical review, input and oversight to development of protocols, Investigator brochures, regulatory filings, study summaries/ reports and manuscripts for publication
11) Provide critical medical review and analysis of Investigator-initiated protocols
12) Seek and work with thought leaders and most renowned clinical experts in fields of interest to the company to obtain advice and guidance on clinical research plans and to gain insight into FDA review requirements
13) Oversee Investigator network to be involved in future company-sponsored trials
14) Ensure successful and timely completion as well as regular reporting to management of progress for company-sponsored trials
15) Review, assess and report to management/business units or regulatory agencies (as appropriate) any adverse events reported to company
16) Work with Regulatory Affairs to develop appropriate SOPs to support the business
17) Provide adequate support, documentation, oversight and monitoring of investigator-initiated trials (as needed)
18) Establish relationships with key investigators in evaluating benefits of DHA outside of company's core application areas
19) Support new technology and business development through evaluation and due diligence relating to the medical benefits of new, non-DHA products which may be acquired or licensed
20) Facilitate good communication and coordination between Clinical Research, Sales & Marketing, Regulatory Affairs, Operations and Quality Assurance
21) Maintain medical and scientific skills by attending educational courses (as appropriate)
22) Ensure that all reports maintain skills appropriate to their jobs
23) Participate in academic and administrative organizations (as appropriate) for the current needs of the company and its clinical research program
24) Keep abreast of scientific literature relating to the company’s current and future products
25) Perform other duties as assigned by management
26) Oversee and direct the activities of others on the Medical Research Team, such as clinical project managers and clinical research scientists
27) Delegate project tasks as well as establish goals and timelines for team members
28) Lead and direct the work of other Medical Research staff on projects
29) Manage the performance and development of Medical Research staff and any outside consultants or contract service providers who may be involved in medical/clinical research
30) Guide team members to write manuscripts, reports or abstracts for publication
2) Handle design and implementation of preclinical and clinical studies conducted under IND regulations and/or for support for NDA submissions (as needed)
3) Present aspects of the medical clinical research program to the Research Management Committee – Clinical
4) Develop written reports and make oral presentations
5) Work with Discovery Team to evaluate potential new or under-explored benefits of DHA
6) Develop and maintain plans for staffing and budget for Medical Research in consultation with the Executive Director of Clinical Research
7) Support the research program based upon a pre-determined strategy of what capabilities the company must have in–house and what may reasonably be outsourced
8) Build and maintain the Medical Research staff and assist with training
9) Maintain Clinical Research as a Good Clinical Practice operation with active, up to date, SOPs and training of staff
10) Provide medical review, input and oversight to development of protocols, Investigator brochures, regulatory filings, study summaries/ reports and manuscripts for publication
11) Provide critical medical review and analysis of Investigator-initiated protocols
12) Seek and work with thought leaders and most renowned clinical experts in fields of interest to the company to obtain advice and guidance on clinical research plans and to gain insight into FDA review requirements
13) Oversee Investigator network to be involved in future company-sponsored trials
14) Ensure successful and timely completion as well as regular reporting to management of progress for company-sponsored trials
15) Review, assess and report to management/business units or regulatory agencies (as appropriate) any adverse events reported to company
16) Work with Regulatory Affairs to develop appropriate SOPs to support the business
17) Provide adequate support, documentation, oversight and monitoring of investigator-initiated trials (as needed)
18) Establish relationships with key investigators in evaluating benefits of DHA outside of company's core application areas
19) Support new technology and business development through evaluation and due diligence relating to the medical benefits of new, non-DHA products which may be acquired or licensed
20) Facilitate good communication and coordination between Clinical Research, Sales & Marketing, Regulatory Affairs, Operations and Quality Assurance
21) Maintain medical and scientific skills by attending educational courses (as appropriate)
22) Ensure that all reports maintain skills appropriate to their jobs
23) Participate in academic and administrative organizations (as appropriate) for the current needs of the company and its clinical research program
24) Keep abreast of scientific literature relating to the company’s current and future products
25) Perform other duties as assigned by management
26) Oversee and direct the activities of others on the Medical Research Team, such as clinical project managers and clinical research scientists
27) Delegate project tasks as well as establish goals and timelines for team members
28) Lead and direct the work of other Medical Research staff on projects
29) Manage the performance and development of Medical Research staff and any outside consultants or contract service providers who may be involved in medical/clinical research
30) Guide team members to write manuscripts, reports or abstracts for publication
II. List of Medical researcher qualifications
1) MD/MD, Ph. D. with minimum 5 years of experience in clinical research leadership roles
2) Board certification and a US license a plus
3) Successful track record in clinical research including experience in pharmaceutical product development as well as successful FDA negotiation for new Rx product labeling and release
4) Nutritional products experience
5) Experience in products in pediatrics, neurology, nutrition or cardiology preferred
6) Experience in performing clinical research in a smaller company environment a plus
2) Board certification and a US license a plus
3) Successful track record in clinical research including experience in pharmaceutical product development as well as successful FDA negotiation for new Rx product labeling and release
4) Nutritional products experience
5) Experience in products in pediatrics, neurology, nutrition or cardiology preferred
6) Experience in performing clinical research in a smaller company environment a plus
III. Tips to write job description
1. Too-long job description:
Looking at a too-long job description can frighten the candidates off and drive the away. A job description, no matter how important the job is, should not be included in more than 3 pages. If one focuses on too many things at a time, he shall definitely lose focus on the main items and get overwhelmed by the remaining; So, keep it concisely.
2. Too-short job description:
While too-long can be a problem, too-short is more a problem. It will ruin the meaning of the job description. A too-short one means it lacks necessary details and therefore, the candidate will not be able to understand while reading it.
3. Listing unnecessary functions or job duties:
Just classifying these into the “others” category will save you a lot of effort and space. On the other hand, the job description will become more dilute and easy to be neglected.
4. Key functions
Not listing key functions as required for the job can be a fatal mistake to a job description.
5. Grammar and spelling
Poor grammar and having spelling errors can ruin the job description, too. Never think that as you are the employer, you may have the right to make grammar or spelling errors while requires other not to. A job description with such errors is easily to be mistaken as a fake or ghost ads; as a result, the candidate will turn away from it.
6. Not specific enough:
Be specific and concise; if you don’t address the specific, then what the job description is for. It is for the candidate to understand just exactly what he needs to do or needs to have. Lacking details can confuse the candidates very well.
7. Not having the job description reviewed by others:
This is also a common mistake. One may be subject to bias, but more than one, especially with the help of those external advisor, the job description can be more perfect.
8. Using buzzwords or abbreviations:
In fact, it is not necessary at all to use such in a job description.
9. Using slang or legal words:
Just use common wording to communicate with others and don’t do anything extraordinarily.
10. Not updating the job description:
The same job may require different duties and responsibilities in different times, so, you cannot use the same job description for 2 different times.
